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74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.0-999.0, Coronary Artery Disease Stable, unstable angina pectoris or ACS Significant lesion* of LMCA ostium, mid-shaft and/or bifurcation and with no more than three additional non-complex** PCI lesions Patient eligible to be treated by CABG and by PCI Signed informed consent. *Visually assessed diameter stenosis >50% or fractional flow reserve <0.80. **Length <25 mm, non-CTO, non-2-stent bifurcation, non-calcified and non-tortuous vessel morphology coronary lesion ST-elevation infarction within 24 hours CABG clearly better treatment option (LMCA stenosis and >3, or complex** additional coronary lesions) Patient is in too high risk for CABG Expected survival <1 year Allergy to aspirin, clopidogrel or ticlopidine Allergy to Biolimus. **Length >25 mm, CTO, 2-stent bifurcation, calcified or tortuous vessel morphology coronary lesion | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 30.0-80.0, Carotid Artery Disease Stroke Myocardial Infarction Angina Pectoris Consecutive patients with coronary artery disease admitted in our hospital Patients with history of previous cerebrovascular event History of vasculitis, intermittent inflammatory, infectious, or neoplastic conditions likely to be associated with an acute-phase response | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 50.0-999.0, Fractured Neck of Femur Fractured neck of femur surgical fixation performed under spinal anaesthesia ASA I to III Patient refusal Coagulation disorders Head injury or other associated injuries Previous vascular surgery in the femoral area Loss of consciousness and signs of acute coronary syndrome Mini-Mental Score < 25 (see appendix 3) Allergy to lignocaine Skin lesions/infection at site of injection Sepsis | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 65.0-75.0, Adaptation Reaction 75 year old men healthy non-smoking non-hypertension non cardiac disease smoking cardiac disease biomechanical disorders cardiac medication | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-55.0, Migraine Is between the ages of 18 and 55 years Has been previously diagnosed as suffering from migraine, in accordance with the ICHD-2 Classification (2nd), with or without aura Experiences at least 2 migraines per month, but less than 15 headache days per month (over the last 3 months) Has age of onset of migraine less than 50 years old Is able to give written Informed Consent Has a history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma Has a lesion (including lymphadenopathy) at the GammaCore™ treatment site Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of TIA or CVA), congestive heart failure (CHF), coronary artery disease or recent myocardial infarction Has a history or baseline ECG that identifies the presence of a clinically significant unstable cardiac arrhythmia, second degree heart block type II, history of ventricular tachycardia or ventricular fibrillation, or known cardiac syndromes that may be associated with increased risk of sudden death in otherwise healthy people Has had a previous bilateral or right cervical vagotomy Has a clinically significant irregular heart rate or rhythm Has uncontrolled high blood pressure Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant Has a history of carotid endarterectomy or vascular neck surgery on the right side Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore™ stimulation site | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 40.0-999.0, Osteoarthritis of the Knee Patient is at least 40 years of age Clinical diagnosis of osteoarthritis of the knee for greater than 6 months based on clinical and radiographic Female patients of childbearing potential must have a negative pregnancy test prior to study enrollment and must agree to remain abstinent, and use barrier, intramuscular, or implanted contraceptives from Visit 1 until 28 days after the last dose of study medication Patient is of American Rheumatism Association (ARA) functional Class I, II, or III Patient is willing to limit alcohol intake to 2 or less drinks per day during study and the follow-up period Patient is willing to avoid unaccustomed physical activity for the duration of the study and follow-up period With the exception of osteoarthritis, the patient is judged to be in good general health based on medical history, physical exam, and routine laboratory tests Patient is able to read, understand and complete study questionnaires, including questions requiring a visual analog scale (VAS) response Patient provides written informed consent for the trial For prior non-steroidal anti-inflammatory drug (NSAID) users only, the patient has a history of positive therapeutic benefit with NSAIDs and has taken an NSAID prior to study enrollment and at a therapeutic dose level prior to study enrollment (Visit 1) Patient has a concurrent medical/arthritic disease that could confound or interfere with evaluation of efficacy Patient is legally incompetent (e.g., a minor or mentally incapacitated), or has active psychosis, or significant emotional problems at the time of the study which in the view of the investigator are sufficient to interfere with the conduct of the study Patient has a history of gastric or biliary surgery (including gastric bypass surgery), or small intestine surgery that causes clinical malabsorption Patient is allergic to, or has a history of a significant clinical or laboratory adverse experience associated with etoricoxib or celecoxib or any of their constituents Patient is allergic to acetaminophen/paracetamol, or has hypersensitivity (e.g., bronchoconstriction in association with nasal polyps) to aspirin or NSAIDs Patient has an estimated glomerular filtration rate is less than or equal to 30 ml/min Patient has Class II-IV congestive heart failure Patient has established ischemic heart disease, cerebrovascular disease, or peripheral vascular disease Patient has uncontrolled hypertension with an diastolic exclusionary limit of > 90 mm Hg and a systolic exclusionary limit of > 140 mm Hg Patient has moderate or severe hepatic insufficiency defined as Child Pugh score > 6 | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 30.0-999.0, Cerebrovascular Disease TIA or stroke in the MCA territory refractory to aggressive anti-platelet and regular statin therapy in 3 months 2. Symptomatic MCA M1 segment stenosis ≥ 70% confirmed with DSA 3. Successfully treated with PTAS without acute surgical complications in 12 hours after operation 4. All patients provided fully informed consent Using angiotensin-converting enzyme inhibitors 2. Severe cardiopulmonary dysfunction, chronic liver disease (A / G inversion, ALT increased 2-fold greater than normal), abnormal renal function (serum creatinine greater than 1.5 times normal) 3. Allergies, the history of allergy to multi-drug 4. The history of cerebral hemorrhage, brain tumors, brain trauma, cerebral embolism and other brain lesions 5. During pregnancy or breast-feeding 6. Not expected to complete follow-up | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.5-6.0, Nursemaid Elbow Pulled Elbow Pulled elbow suspected in any child presenting one of the following: 1. History of an adult or bigger person that had pulled the child's elbow non-intentionally 2. Presence of intense pain at the arrival at the emergency department and unwilling to move the arm Any suspect of injury that could be intentional (child abuse) Any suspicion child of suffering a possible fracture (the mechanism of the injury was not from pulling the child's arm, the arm presents obvious deformity, ecchymoses, edema, etc.) The mechanism was from multiple trauma Any chronic disease affecting the adequate bone mineralization (vitamin D deficiency, osteogenesis, etc.) | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 50.0-90.0, Carotid Stenosis symptomatic and asymptomatic patients with finding of significant carotid stenosis patients with acute injuries to the baseline MRI of the brain patients with active bleeding contraindications to statin therapy and MRI contraindications (pacemaker/claustrophobic) | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 55.0-999.0, Cognitive Impairment, no Dementia (CIND) Age 55 years or older Sedentary Score of 19-25 on the Montreal Cognitive Assessment Battery or verbal fluency score of =< 12 or animal fluency score of =<15 At least one cardiovascular risk factor (hypertension, diabetes, cholesterol, obesity, current smoking, or family history) or a documented history of cardiac disease (myocardial infarction, coronary artery bypass grafting, peripheral vascular disease, >70% stenosis, or mild stroke without residual deficit) Any significant neurological disease other than CIND, such as Parkinson's disease, multi-infarct dementia, Huntington' s disease, progressive supranuclear palsy, brain tumor, normal pressure hydrocephalus, subdural hematoma, seizure disorder, multiple sclerosis, or history of head trauma with persistent neurological deficits Psychotic disorder within the past two years (DSM IV criteria) or acutely suicidal History of alcohol or substance abuse or dependence within the past two years (DSM IV criteria) History of schizophrenia Any significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol including a history of systemic cancer within the past 5 years (nonmetastatic skin cancers are acceptable) Myocardial infarction (within the past 3 months) or unstable or severe congestive heart failure (e.g. class III-IV heart failure) End-stage pulmonary disease; uncontrolled diabetes mellitus or uncontrolled hypertension(systolic BP>170 or diastolic BP >100 mm Hg on medication) Musculoskeletal disorders precluding the ability to exercise (e.g. severe arthritis) | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.0-999.0, Knee Arthroplasty recommended total knee arthroplasty Unwilling to participate 2. Unable to complete questionnaire in English | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 40.0-80.0, Internal Carotid Artery Stenosis stenosis of internal carotid artery indication to endarterectomy or stenting age 40-80 years sufficient temporal bone window for TCD with detectable blood flow in MCA independent patient (modified Rankin score 0-2) informed consent signed by the patient contraindication to MRI examination (pace-maker, implanted metal material, claustrophobia) | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 40.0-90.0, Coronary Artery Bypass Graft Redo Heart Valve Diseases age 40-90 years sufficient temporal bone window for TCD with detectable blood flow in MCA independent patient (modified Rankin score 0-2) informed consent signed by the patient CS will be performed as an elective surgery with an extracorporeal circulation contra-indication for MRI examination (pace-maker, implanted metal material, claustrophobia) emergent surgery acute myocardial infarction combined cardiac surgery combined cardiac and carotid surgery | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 19.0-90.0, Carotid Stenosis Femoral Arterial Stenosis Carotid Bruit Asymptomatic Carotid Murmur age 19-90 years having clinical ultrasound evaluation of carotid or femoral artery under age 19; over age 90 years | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-80.0, Coronary Heart Disease Use of a standard-of-care statin at a stable dose, or intolerance of statins, without use of other lipid modifying therapies Fasting LDL cholesterol 90-250 mg/dL on the statin regimen above And at least one of the following Coronary heart disease (CHD) with a history of myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), or prior coronary angiography demonstrating coronary atherosclerosis A CHD risk equivalent condition, including diabetes mellitus (type 1 or 2), chronic kidney disease, prior stroke, carotid disease, peripheral arterial disease, or abdominal aortic aneurism >/=2 CHD risk factors (age >/= 45 years for men or >/= 55 years for women; smoking; hypertension; low HDL cholesterol; family history of premature CHD) and a high risk of a CV event based on risk estimation systems Severe congestive heart failure (NYHA Class III-IV) or left ventricular ejection fraction </= 35% Recent (within 3 months) MI, unstable angina, stroke, transient ischemic attack, CABG, PCI, hospital admission for heart failure, major surgery, uncontrolled cardiac arrhythmia (other than atrial fibrillation or flutter), or initiation of renal replacement therapy (dialysis) Fasting serum triglyceride level >/= 400 mg/dL Homozygous familial hypercholesterolemia Poorly controlled diabetes mellitus, hypertension or thyroid disease Liver or muscle disease, including abnormal test results at screening Pregnant or lactating The above list is not intended to contain all factors relevant to a patient's for the study | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Diabetes Mellitus type 2 diabetes mellitus documented coronary artery disease treatment with aspirin for at least 7 days before randomization one of the following additional defined from our previous study9: current smoking, hs-CRP > 4mg/L, fibrinogen > 4g/L and/or platelet count > 270 103/mm3 oral anticoagulants, heparin, thrombolytic agents, non-steroidal anti-inflammatory drugs, prasugrel family or personal history of bleeding or thrombophilic disorders platelet count > 600x103/mm3 or < 150x103/mm3 hematocrit > 50% or < 25% creatinine clearance < 30mL/min low compliance before enrollment cancer considered not in remission or those having undergone major surgery within the month prior to enrollment | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 45.0-999.0, Cardiovascular Diseases Any evidence of coronary artery disease (CAD) over the preceding 10 years, as defined by any of the following defined by previous myocardial infarction stable or unstable angina history of atherosclerotic stenosis ≥70% of the diameter of any coronary artery on conventional or computed tomographic (CT) coronary angiography history of angioplasty, stenting, or coronary artery bypass surgery) Any evidence of stroke in the preceding 10 years Peripheral Arterial Disease over the preceding 10 years, as defined by any of the following ankle/arm ratio <0.9 of systolic blood pressure in either leg at rest, angiography or Doppler demonstrating >70% stenosis in a cardiac artery intermittent claudication vascular surgery for atherosclerotic disease Refusal to provide Informed Consent Statement neurocognitive or psychiatric condition that may hinder collection of reliable clinical data (defined at the trial investigator's discretion) Life expectancy less than 6 months Pregnancy or lactation Liver failure with a history of encephalopathy or anasarca Renal Failure with indication for dialysis Congestive heart failure Previous organ transplantation Wheelchair use Any restrictions to receiving an oral diet | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 65.0-999.0, Muscle Weakness Syndrome; Institutionalization Other Diagnoses, Comorbidities, and Complications clinically stable residents, institutionalized at least 1 year Barthel Index less than 95 points inability to independently walk more than 10 meters or inability to effectively use a wheelchair Mini-Mental Status Examination score of at least 20 points (i.e., subjects without moderate or severe cognitive deterioration) significant chronic cardiorespiratory diagnoses (e.g. moderate-severe COPD) an acute cardiorespiratory episode during the last 2 months prior to the study neurological, muscular, or neuromuscular problems interfering with the capacity to engage in the tests and training protocols active smokers or former smokers who had stopped smoking less than 5 years ago a terminal disease | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Renal Cell Carcinoma Locally recurrent or metastatic RCC requiring systemic therapy following treatment (tx) with sorafenib, sunitinib, pazopanib, or placebo on an adjuvant study Required to have primary or recurrence tumor samples containing clear cell variant RCC with <50% of any other histology Recurrence must occur ≥ 3 months following end of exposure to the adjuvant intervention Received ≥ 3 six week cycles of prior adjuvant tx with sorafenib, sunitinib, pazopanib or placebo in the adjuvant setting on a clinical trial, or recurrence >3 months of tx on an adjuvant placebo arm Required to have measurable recurrent or metastatic disease that is not curable by standard radiation therapy or surgery Male or female, ≥ 18 years old ECOG PS 0 or 1 Blood pressure (B/P) must be controlled at time of enrollment. Tx with antihypertensive medication(s) is allowed. Controlled B/P is defined as in clinic measurement of systolic B/P ≤ 140 mm Hg AND diastolic B/P ≤ 90 mm Hg. If B/P is uncontrolled at time of planned enrollment, tx or optimization with antihypertensive medication(s) may be initiated in order to control B/P. Patient may be considered for enrollment when this has happened Women must not be pregnant or breastfeeding Men and women who are of reproductive potential must be willing to employ an effective method of birth control/contraception | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-65.0, Chronic Migraine Is between the ages of 18 and 65 years Has been previously diagnosed as suffering from migraine, in accordance with the ICHD-2 Classification (2nd), with or without aura Experiences at least 15 headache days per month (over the last 3 months) Has age of onset of migraine less than 50 years old Agrees not to use any migraine prevention treatments (including Botox injections) and/or medications (exclusive of medications taken for acute relief of migraine symptoms) Is able to provide written Informed Consent Agrees to refrain from changing the type or dosage of any prophylactic medications for indications other than chronic migraine that in the opinion of the clinician may interfere with the study Has a history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the GammaCore treatment site Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of TIA or CVA), congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction Has an abnormal baseline ECG (e.g. second and third degree heart block, atrial fibrillation, atrial flutter, recent history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction) Has had a previous bilateral, right, or left cervical vagotomy Has uncontrolled high blood pressure Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant Has a history of carotid endarterectomy or vascular neck surgery on the right side Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore stimulation site Has a recent or repeated history of syncope | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Carotid Artery Disease Patient must meet one of the following regarding neurological symptom status and degree of stenosis Symptomatic: Stenosis must be greater than or equal to 50% as determined by angiogram and the patient has a history of stroke (minor or non-disabling), TIA and/or amaurosis fugax within 180 days of the procedure Asymptomatic: Stenosis must be greater than or equal to 70% as determined by angiogram without any neurological symptoms within the prior 180 days. 2. Target vessel must meet diameter requirements for stent (refer to selected stent IFU for diameter requirements). 3. Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA). 4. Patient is greater or equal to 18 years of age. 5. Patient has no childbearing potential or has a negative pregnancy test within one week prior to the study procedure. 6. Patient understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Investigational Review Board/Ethics Committee of the respective clinical site prior to the procedure. This will be obtained prior to participation in the study. 7. Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations. 8. Patient meets at least one of the anatomic or clinical high-risk criteria Patient has chronic atrial fibrillation. 2. Patient has had any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation. 3. Patient has an evolving stroke. 4. Patient has severe dementia. 5. Patient has a history of spontaneous intracranial hemorrhage within the past 12 months. 6. Patient has had a recent (<7 days) stroke of sufficient size (on CT or MRI) to place him or her at risk of hemorrhagic conversion during the procedure. 7. Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days. 8. Patient has active bleeding diathesis or coagulopathy or will refuse blood transfusion. 9. Patient had or will have CABG, endovascular stent procedure, valve intervention or vascular surgery within 30 days before or after the intervention. 10. Patient has had a recent GI bleed that would interfere with antiplatelet therapy. 11. Life expectancy of < 12 months post procedure. 12. Patient has history of intolerance or allergic reaction to any of the study medications or stent materials (refer to stent IFU), including aspirin (ASA), ticlopidine, clopidogrel, prasugrel, statin or contrast media (that can't be pre medicated). Patients must be able to tolerate statins and a combination of ASA and ticlopidine, ASA and clopidogrel or ASA and prasugrel. 13. Myocardial Infarction within 72 hours prior to the intervention. 14. Presence of a previous placed intravascular stent in target vessel or the planned arteriotomy site. 15. Patient has had neurologic illnesses within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke (e.g. partial or secondarily generalized seizures, complicated or classic migraine, tumor or other space-occupying brain lesions, subdural hematoma, cerebral contusion or other post-traumatic lesions, intracranial infection, demyelinating disease, moderate to severe dementia, or intracranial hemorrhage). 16. Patient with a history of major stroke (CVA or retinal embolus) with major neurological deficit likely to confound study endpoints within 1 month of index procedure. 17. Patient has Hgb <10 g/dl, platelet count <125,000/μl, uncorrected INR >1.5, bleeding time >1 minute beyond upper limit normal, or heparin-associated thrombocytopenia. 18. Patient has an intracranial tumor. 19. Patient is actively participating in another drug or device trial (IND or IDE) that has not completed the required protocol follow-up period. 20. Patient has inability to understand and cooperate with study procedures or provide informed consent. 21. Occlusion or [Thrombolysis In Myocardial Infarction Trial (TIMI 0)] "string sign" >1cm of the ipsilateral common or internal carotid artery. 22. Patient has vertebrobasilar insufficiency symptoms only, without clearly identifiable symptoms referable to the study carotid artery. 23. Knowledge of cardiac sources of emboli.e.g. left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma). 24. Recently (<60 days) implanted heart valve (either surgically or endovascularly), which is a known source of emboli as confirmed on echocardiogram. 25. Ostium of Common Carotid Artery (CCA) requires revascularization. 26. Presence of extensive or diffuse atherosclerotic disease involving the proximal common carotid artery that would preclude the safe introduction of the study device. 27. The patient has less than 5cm between the clavicle and bifurcation, as assessed by duplex Doppler ultrasound. 28. Bilateral carotid stenosis if intervention is planned within 37 days of the index procedure. 29. An intraluminal filling defect (defined as an endoluminal lucency surrounded by contrast, seen in multiple angiographic projections, in the absence of angiographic evidence of calcification) that is not associated with an ulcerated target lesion. 30. Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis greater in severity than the lesion to be treated, cerebral aneurysm > 5 mm, AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal angiographic findings. 31. Patient has had a previous intervention in the ipsilateral proximal CCA. 32. Patient has had a TIA or amaurosis fugax within 48 hours prior to the procedure. 33. Patient has contralateral lateral recurrent, laryngeal or vagus nerve injury. 34. Patient is otherwise unsuitable for intervention in the opinion of the investigator | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 70.0-999.0, Non Small Cell Lung Cancer (NSCLC) Signed written informed consent Male or female patient Greater than or equal to 70 years of age Diagnosis of NSCLC histologically or cytologically confirmed Internal Association for the Study of Lung Cancer Version 7 Stage IV disease or recurrence after prior surgery or radiotherapy Progression following one line of prior chemotherapy consisting of a platinum agent plus a standard cytotoxic partner agent other than a taxane, typically pemetrexed gemcitabine or vinorelbine A single agent non cytoxic regimen if the patient has a molecular change that the non cytotoxic regimen would be expected to be efficacious for epidermal growth factor receptor (EGFR) mutation for erlotinib and (EML4) anaplastic lymphoma kinase (ALk) or ROS1 for crizotinib Eastern Cooperative Oncology Group performance status 0 to 2 Adequate organ and bone marrow function as defined by Absolute neutrophil count greater than or equal to 1500 cells/mm3 Prior taxane therapy for any indication Less than 3 weeks elapsed since prior exposure to chemotherapy Pre existing neuropathy greater than grade 1 Other active invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years localized squamous cell carcinoma of the skin basal cell carcinoma of the skin, carcinoma in situ of teh cervix or other malignancies requiring locally ablative therapy only will not result in Concomitant anticancer therapy immunotherapy or radiation therapy within prior 4 weeks Have received treatment within the last 30 days prior to study entry with any drug that has not receive regulatory approval for an indication at the time of study entry Uncontrolled intercurrent illness including but not limited to ongoing or active infection requiring IV antibiotics symptomatic congestive heart failure unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situations that would limit compliance with study requirements Pregnant women are excluded due to the potential for teratogenic or abortifacient effects of nab paclitaxel because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued prior to participation of the mother on study Known hypersensitivity to protein bound paclitaxel Any other concurrent condition that in the investigators opinion would jeopardize compliance with the protocol | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Stroke Upper Extremity Paresis post-acute stroke patients with unilateral first-time MCA stroke sustained . (more than 6 months ago prior to the enrolment to the study) Patients' residual motor impairments in the affected hand and arm should be greater than stage 3 on the Chedoke McMaster scale Patients with moderate apraxia, aphasia or dementia, and patients with severe sensory loss in the paretic hand, severe language-communication disability, posture problems, involuntary movements, high-blood pressure, depression or other psychological disorders, metal in body that interferes with MEG and MRI measurements | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Ischemic Cardiomyopathy Coronary Artery Disease years of age or older Patients with ischemic heart disease manifested by Canadian class II or greater angina and/or New York Heart Association class II, III or IV exercise intolerance AND who have undergone diagnostic coronary angiography demonstrating at least 70% diameter narrowing of at least 2 major coronary arteries or branches or at least 50% diameter narrowing of the left main coronary artery Left ventricular systolic dysfunction evaluated by echocardiography or LV angiography (LV ejection fraction less than or equal to 49%) No contraindications or exclusions (see below) Willingness to participate and ability to provide informed consent Contraindications to magnetic resonance imaging Need for emergent revascularization Need for concomitant surgical procedure at the time of CABG (e.g. valve repair or replacement, aneurysm resection, etc.) Hemodynamically unstable patients Patients with confirmed transmural myocardial infarction within 4 weeks, and/or rising cardiac biomarker proteins (i.e. troponin), and/or worsening ECG changes Prior CABG surgery Stroke within 1 month prior to planned CABG Diagnosed with human immunodeficiency virus (HIV) or any other immune disorder or immunosuppressive medication (e.g. prednisone, cyclophosphamide, etanercept, etc.) Organ dysfunction Contra-indication for bone marrow aspiration (Thrombocytopenia < 50.000 mm3, INR > 2.0, use of antiplatelet agents other than aspirin) | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Hypertension Arthritis Coronary Artery Disease Hepatitis Diabetes Asthma Hyperlipidemia HIV On CMHC roster of active patients Presence of a serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder, major depression, obsessive-compulsive disorder, or post-traumatic stress disorder Chronic Medical Condition as noted in the CMHC chart or via self-report: (hypertension; arthritis; heart disease; diabetes; and asthma/COPD) cognitive impairment based on a score of > 3 on a 6-item, validated screener developed for clinical research | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 50.0-999.0, Dizziness at least 50 years of age documented balance or mobility problems normal vestibular function, including otolith function cognitive impairment progressive medical issues that would impact mobility (e.g., Parkinson's disease, cerebellar atrophy) dizziness due to orthostatic hypotension or Benign Paroxysmal Positional Vertigo (BPPV) | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 40.0-74.0, Carotid Atherosclerosis Men aged 40 to 74 years Subclinical carotid atherosclerosis detected by B-mode ultrasound (increased intima-media thickness 1100-2000 mcm) Arterial normotension or mild arterial hypertension (systolic blood pressure <160 mm Hg, diastolic blood pressure <90 mm Hg) Absence of chronic diseases demanding permanent drug administration (more than 2 month per year) Personal history or diagnostic of following diseases: 1. Transient ischemic attacks 2. Presence of chronic diseases demanding permanent drug administration (more than 2 month per year) 3. Condition of patients moderate to severe Indications for surgical treatment of atherosclerotic lesions localized in the extracranial brachiocephalic system Individual intolerance of Allicor or appearance of side effects | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-35.0, Vestibulodynia non pregnant women between 18-35 naïve to HCs or other hormonal medications Patients able to provide Informed Consent and complete questionnaires Patient intends to use HCs for at least one year On exam before initiation of HCs, patient does not have primary PVD, pelvic floor hypertonicity, vaginismus or congenital abnormalities Patient will be available for follow up appointments Patient is willing to undergo gynecologic examination, if dyspareunia develops Patients with endocrine disturbances (including PCOS), liver diseases and eating disorders Patients who suffer from Hypertension, Migraine with aura or clotting disturbances Patients that experience pain with intercourse or tampon insertion Patients that have other contraindications for HCs use | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-75.0, Pain Disorder Sensory Deficit Adults ASA physical status I-III BMI<30 No contraindications to study procedures Pediatric patients ASA physical status IV BMI>30 Contraindications to study procedures Hypersensitivity to local anesthetics | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-65.0, Carotid Artery Occlusion Middle Cerebral Artery Occlusion Stroke Age ranging between 18 and 65 years Digital subtraction angiography imaging studies demonstrating occlusion of unilateral ICA or MCA Digital subtraction angiography imaging studies demonstrating less than 50% stenosis of any other vessels especially contralateral ICA and MCA Modified Rankin Scales (mRS) 0-2 Qualifying TIA or ischemic stroke in the territory of the occluded ICA or MCA must have occurred within the past 12 months The most recent stoke attacked more than 3 weeks ago The neurological deficit must be stable for more than 1 month No massive cerebral infarction (>50% of the MCA territory) in CT or MRI study CT Perfusion demonstrates "misery perfusion" Competent to give informed consent Other neurovascular disease (such as cerebral aneurysm or arteriovenous malformation) conditions likely to cause focal cerebral ischemia Known unstable angina or myocardial infarction within recent 6 months Pregnant or perinatal stage women Blood coagulation dysfunction Any diseases likely to death within 2 years Past history of EC-IC bypass surgery Any contraindications or allergy to aspirin or clopidogrel Any heart disease likely to cause cerebral ischemia including prosthetic valves, infective endocarditis, atrial fibrillation, sick sinus syndrome, myxoma and cardiomyopathy with ejection fraction less than 25% Allergy to iodine or radiographic contrast media Serum creatinine > 3mg/dl | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.0-999.0, Ischemic Heart Disease Congestive Heart Failure Peripheral Vascular Disease Cerebrovascular Disease Atrial Fibrillation Cerebrovascular Atherosclerosis Clinical Diagnosis of the following: Ischemic Heart Disease,MI,non-MI,congestive heart failure,peripheral vascular disease, cerebrovascular disease CVA,TIA,patients with first AMI diagnosis from community physicians if they were hospitalized for lasting at least 3 days during a 30-day period prior to diagnosis Patients with prior coronary artery bypass grafting(CABG) or percutaneous coronary intervention (PCI), using relevant Current Procedural Terminology (CPT) codes patients who were diagnosed as suffering from CHD by primary physician or general hospitals prior to 2000 with no further indication Patients whose primary physician reported that the patient is CHD-free providing adequate medical records | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Systolic Heart Failure Peripheral Chemoreceptor Hypersensitivity History of heart failure class II-III according to NYHA within at least 6 months prior to Stable clinical state within at least 4 weeks prior to Subject >= 18 years old Left ventricular ejection fraction ≤ 45% evaluated by transthoracic echocardiography (Simpson's method) Carotid body present in computer cervical angiotomography History of exacerbated peripheral chemoreceptor sensitivity determined as >0.6L/min/%SpO2 Able and willing to give written informed consent Unstable angina pectoris, coronary attack, coronary revascularization, exacerbation of heart-failure requiring hospitalization, clinically significant infection, surgery under general anesthesia within 3 months prior to History of stroke, transient ischemic attack (TIA), or clinically significant chronic neurological disorder History of heart transplant Pregnancy or anticipation of pregnancy Hemodialysis or peritoneal dialysis patients Obstructive carotid atherosclerotic disease with >50% stenosis COPD stage III and IV according to GOLD 2007 Unable to perform the spiroergometric assessment Any significant anomaly in additional investigation which may increase the risk of study procedure | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Chemotherapeutic Agent Toxicity Multiple Myeloma Peripheral Neuropathy Patients with a diagnosis of multiple myeloma who received bortezomib at a dose of 1.3mg/m2 SQ weekly No evidence of severe pre-existing peripheral neuropathy, NCI-CTCAE v4.03 =< 2 Performance status =< 2 on the Eastern Cooperative Oncology Group (ECOG) performance scale Concurrent use of thalidomide, vincristine, platinum compound, or other agent known to cause significant neuropathy (concurrent lenalidomide will be allowed) Hospitalization with clinical evidence of active infections as manifested by recurrent fevers, positive blood culture results, or requiring intravenous antibiotic therapy Inadequate liver and renal function with liver transaminases 3x the upper limit of normal Glomerular filtration rate (GFR) according to Cockcroft-Gault < 30 mL/min Uncontrolled congestive heart failure Uncontrolled mood disorders Fasting blood glucose >150mg/dL or blood sugar (non-fasting) >200mg/dL if no history of diabetes. Uncontrolled diabetes with HgA1C greater 7% with last evaluation Seizure disorder Monosodium glutamate (MSG) allergy or soy allergy Life expectancy of shorter than 3 months based on clinical laboratory parameters and the investigator's opinion | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Carotid Artery Diseases Stroke years of age Anticipated patient life expectancy of at least 1 year Patient or authorized representative, signed a written Informed Consent form Patient is willing to comply with the protocol requirements Candidate for catheter-based therapy of a single stenosis located in the internal carotid artery (ICA) or the carotid bifurcation, suitable for treatment with a single FDA-approved stent with a carotid use indication Reference vessel diameter for intended filter location between 3.5mm and 6.0mm An adequate "landing zone" of at least 30mm Patients with severe symptomatic or asymptomatic carotid artery stenosis, to be ≥ 50% for symptomatic patients OR ≥ 80% for asymptomatic patients At least one high surgical risk either anatomical or co-morbid risk factors, as listed below: Category I Anatomical high risk factors Total occlusion or near-occlusion of the target vessel Severe lesion calcification Presence of an alternate source of emboli Presence of a filling defect, or angiographically visible thrombus, at target site A greater than 50% CCA lesion proximal to the target or a distal (intracranial) lesion more severe than the target lesion Evolving, acute or recent stroke within the last 30 days Major stroke with a residual neurological deficit that would confound neurologic assessment Vertebrobasilar insufficiency symptoms only Major operation 30 days before or after the index procedure Ipsilateral intracranial stenosis that requires treatment | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Waldenström's Macroglobulinemia Clinicopathological diagnosis of WM as defined by consensus panel one of the Second International Workshop on WM. Pathological diagnosis has to occur before study and randomization. In addition, pathological specimens have to be sent to the national pathological reference center at study and randomization. The positivity for CD20 can be assumed from any previous bone marrow immunohistochemistry or flow cytometry analysis performed up to 6 months prior to enrollment. in the study will be based on morphological and immunological criteria. Immunophenotyping will be performed in each center and saved locally. Flow cytometry of bone marrow and blood cells will at least one double staining and assess the expression of the following antigens: surface immunoglobulin, CD19, CD20, CD5, CD10 and CD23. Patients are eligible if tumor cells express the following antigens: CD19, CD20, and if they are negative for CD5, CD10 and CD23 expression. Patients with tumor cells positive for CD5 and/or CD23 and morphologically similar to WM cells may be included after ruling out other low grade B-cell malignancies Presence of at least one criterion for initiation of therapy, according to the 2nd Workshop on WM Recurrent fever, night sweats, weight loss, fatigue Hyperviscosity Lymphadenopathy which is either symptomatic or bulky (≥5 cm in maximum diameter) Symptomatic hepatomegaly and/or splenomegaly Symptomatic organomegaly and/or organ or tissue infiltration Peripheral neuropathy due to WM Symptomatic cryoglobulinemia Cold agglutinin anemia Prior systemic treatment of the WM (plasmapheresis and short term administration of corticosteroids < 4 weeks administered at a dose equivalent to < 20 mg/day prednisone is allowed) Patient with hypersensitivity to dexamethasone Serious medical or psychiatric illness likely to interfere with participation in this clinical study Uncontrolled bacterial, viral or fungal infection Active HIV, HBV or HCV infection Known interstitial lung disease Prior allergic reaction or severe anaphylactic reaction related to humanized or murine monoclonal antibody Central Nervous System involvement by lymphoma Prior history of malignancies unless the subject has been free of the disease for ≥ 5 years. Exceptions the following | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-100.0, Takayasu's Arteritis Giant Cell Arteritis Arteritis Vasculitis Aortitis Male and female patients >18 years Diagnosis of Takayasu's arteritis or giant cell arteritis Suspicion of common carotid involvement on the basis of physical examination (cervical bruit), carotidynia, documented CCA involvement on an imaging study (MRA, CTA, or ultrasound), or documented upper extremity large vessel involvement on an imaging study (MRA or CTA or ultrasound) Ability to provide informed consent Prior stroke, carotid surgery or angioplasty Pregnant (or trying to become pregnant) Nursing Known or suspected cardiac shunt Documented hypersensitivity to the contrast agent Severe pulmonary hypertension or unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias, or respiratory failure) | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 30.0-85.0, Carotid Stenosis Cerebral Hyperperfusion Syndrome Blood Pressure Age from 30 to 85 years; 2. Had a middle-grade symptomatic carotid stenosis (more than 50%) or a high-grade asymptomatic carotid stenosis (more than 70%); 3. Underwent CEA 30 days after the last ischemic cerebrovascular event in the case of symptomatic carotid stenosis; 4. Signed the ethical information consent form 5. Underwent TCD study intraoperative and immediately after CEA; 6. The degree of carotid stenosis will be assessed by CT angiography or cerebral digital subtraction angiography (DSA). (The method document came from the North American Symptomatic Carotid Endarterectomy Trial study.) Emergency CEA within 30 days of stroke onset in the case of symptomatic carotid stenosis; 2. No temporal windows to measure the MCAV. 3. Restenosis after CEA or CAS 4. Stenosis caused by non-atherosclerotic diseases 5. Combined severe systematic diseases that markedly decrease the life cycle 6. Allergy to medicines of the study such as Aspirin or Statin 7. Refuse to sign the ethical information consent form | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-75.0, Cancer of the Rectum Histologically proven rectal adenocarcinoma Stages cT3 with risk of local recurrence or cT4, M0 and for which a multidisciplinary meeting recommend preoperative CRT Resectable tumor, or considered as potentially resectable after CRT No distant metastases Patient eligible for surgery Patient aged from 18 to 75 years World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status 0/2 No heart failure or coronary heart disease symptoms (even controlled) No peripheral neuropathy > grade 1 No prior radiotherapy of the pelvis for any reason and no previous CT Metastatic disease Unresectable rectal cancer, including prostatic involvement or extension to pelvic floor muscles Contraindication to 5-FU, or to oxaliplatin or to irinotecan, including Gilbert disease or genotype UGT1A1 Medical history of chronic diarrhea or inflammatory disease of the colon or rectum Medical history of angina pectoris or myocardial infarction Progressive active infection or any other severe medical condition that could jeopardize treatment administration Other concomitant cancer, or medical history of cancer other than treated in situ cervical carcinoma or basocellular carcinoma or spinocellular carcinoma Patient included in another clinical trial testing an investigational agent Pregnant or breast-feeding woman Persons deprived of liberty or under guardianship or incapable of giving consent | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 21.0-999.0, Coronary Artery Disease Cerebral Vascular Disease Peripheral Artery Disease Renal Insufficiency Diabetes COPD Hypertension Active Smoker Cancer CHF Prior DVT/PE • ≥ 21 years of age Subjects undergoing open orthopedic surgery of the hip, knee or spine High-risk subject cohort Coronary artery disease (CAD), or Cerebrovascular disease (CVD) (prior stroke, TIA or carotid artery disease (>70% stenosis), or Peripheral artery disease (PAD), or Age ≥ 60 years and any 2 of the following Renal insufficiency (creatinine clearance < 60ml/min) Diabetes Chronic Obstructive Pulmonary Disease (COPD) • Severe co-morbid condition with life expectancy < 6 months Inability to give informed consent or adhere to follow-up as per protocol | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 65.0-85.0, Acute Myeloid Leukemia Patient > 65 years old and < 85 years old Newly diagnosed Acute Myeloid Leukemia (AML) or post myelodysplastic syndrome diagnosed within 6 months prior to study enrollment Unfit for intensive chemotherapy (at risk to suffer treatment related pejorative toxicities /early death) due to the presence of one or more of the following Dependence in activities of daily living owing to the presence of comorbidities other than those resulting from the deterioration caused by the neoplastic disease. Presence in the patient's medical history of three or more of the following comorbidities, even if they are under control with proper treatment: Congestive heart failure, other chronic cardiovascular diseases, chronic obstructive pulmonary disease, cerebrovascular disease, peripheral neuropathy, chronic kidney failure, hypertension, diabetes mellitus, systemic vasculitis, severe arthritis Presence of geriatric syndromes such as fecal or urinary incontinence, spontaneous bone fractures, mild and moderate dementia, or patients who fall repeatedly, or, patient unwilling to receive intensive chemotherapy Eligible to receive low-dose cytarabine treatment ECOG performance status ≤ 2 Female patients of childbearing potential and males must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and for 6 months after the last dose of Cytarabine or 3 months after last dose of (whichever is the longest) Negative serum pregnancy test at study entry for female subjects of childbearing potential Subscription to social security insurance (if applicable, in accordance with local regulations) Ability to understand, and willingness to sign, a written informed consent document and to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures Patients with M3 AML of FAB classification (APL, acute promyelocytic leukemia) Patients with AML involving chromosome 16 abnormalities or translocation (8:21) (CBF-AML) Patient with secondary AML subsequent to prior malignant blood disorder such as: Myelodysplastic syndrome diagnosed more than 6 months before study entry or Myeloproliferative syndrome Prior therapy to AML (standard therapy or investigational agents) Inadequate organ function : Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis, Serum creatinine concentration > 2 x ULN (Upper Limit of Normal), AST or ALT levels > 3.5xULN or 5xULN if related to AML, Total bilirubin > 2 x ULN, INR > 1.5, unless patient under chronic treatment with anticoagulants (in this case, INR should be within expected ranges for the specific condition), Insulin-dependent or uncontrolled diabetes mellitus Concurrent malignancies other than AML requiring chemotherapy Severe active infection, HIV seropositivity, or known active type B or C viral hepatitis Known or suspected hypersensitivity or intolerance to mannitol Breastfeeding or lactating women | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-75.0, Hypertension Atrial Fibrillation Individual is ≥ 18 and ≤ 75 years of age. 2. More than half a year for definite hypertension. 3. AF is a common superventricular arrhythmia that is characterized by chaotic contraction of the atrium. An electrocardiogram (EGG) recording is necessary to diagnose AF. At least 30 seconds on a rhythm strip in an EGG record and at least 1 AF outbreak which was recorded by EGG and Holter in half a year. 4. Paroxysmal AF Individual ,Paroxysmal AF is defined as recurrent AF (≧2 episodes) that terminates spontaneously within 7 days. Episodes of AF of ≤ 48 hours' duration that are terminated with electrical or pharmacologic cardioversion should also be classified as paroxysmal AF episodes. 5. Individual eligible conditions through renal artery CTA inspection, such as undoubled renal artery on one side, renal artery length≧2cm, diameter≧4mm, and distortion at incept sect. 6. Agree to attend clinic experiment and sign written informed consent Persistent AF Individual, Persistent AF is defined as continuous AF that is sustained beyond seven days. Episodes of AF in which a decision is made to electrically or pharmacologically cardiovert the patient after _≧48 hours of AF, but prior to 7 days, should also be classified as persistent AF episodes. 2. Individual with Severely enlarged left atria≥ 55 mm 3. Individual who reversibility mostly generated AF, such as abnormal hypothyroid or structural heart diseases 4. Individual has experienced renal artery stenosis ，or A history of prior renal artery intervention including balloon angioplasty or stenting. or ineligible conditions through renal artery CTA inspection, such as double renal artery on one side, renal artery length≤2cm, diameter≤4mm, and distortion at incept sect. 5. Individual has experienced a definite acute coronary syndrome in recent 3 months, or a cerebrovascular accident and alimentary canal bleeding within 3 months 6. Individual has experienced sick sinus syndrome 7. Pregnant Women or planning to be Pregnant Women, psychopathy Individual, individual who is sensitive to visualization, individual who can not cooperate with follow-up visit, or individual who researcher think it unsuitable to be included in this study | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.0-999.0, Cataract Type 2 Diabetes Mellitus patients undergoing phacoemulsification combined with IOL implantation for diabetic group: duration of type 2 diabetes mellitus (T2DM) for 10 to 15 years for diabetic group: therapy with oral hypoglycemic agents for glycemic control no other ocular (retinal) or systemic diabetic complications of T2DM patients who had cataract that could result from some other ocular condition, systemic disease (except T2DM for diabetic group) or trauma patients with immune disease, local or systemic inflammation which could affect cytokine concentration in serum or aqueous humor (AH) | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 40.0-999.0, Depression Intracranial Atherosclerosis Coronary Artery Disease Age: 40 years or older Will be having CABG surgery at the Yale New Haven Hospital Be able to provide informed consent Have a household telephone A fluent English speaker, and possessing no communication barrier Be able to come to the study site or to have the study team come to his/her home Has a family member or partner/ friend who could provide collateral information Has had previous CABG surgery History of dementia diagnosis or cognitive impairment (CDR >/= 1) Auditory or visual impairment that would interfere with study procedures Active alcohol or substance abuse problem based CAGE-AID (endorsing two or more items) History of Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, or any Psychotic Disorder by medical history or self-report Presence of non-cardiovascular conditions likely to be fatal within 1 year | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Pancreatic Cancer Understand and voluntarily sign an informed consent form Age greater than or 18 years at the time of signing the informed consent form Able to adhere to the study visit schedule and other protocol requirements Subjects must have a histologically confirmed pancreatic adenocarcinoma that has had an R0 (negative margins) or R1 (microscopically positive margins) resection Subjects must have finished adjuvant therapy, which can chemotherapy and/or chemoradiation therapy or have been determined to be unable to take adjuvant therapy. Although patients will be expected to complete chemoradiation or chemotherapy per physician recommendations, patients who are unable to complete chemotherapy ± radiation therapy secondary to dose limiting toxicities will be eligible provided they meet study criteria Subjects enrolled due to node + disease or R1 resection must be able to undergo randomization within 3 months of finishing adjuvant therapy or the decision that they are unable to take adjuvant therapy. Patients enrolling due to CA 19-9 elevations can enroll any time after adjuvant therapy has completed All previous cancer therapy including radiation, chemotherapy, and surgery, must have been discontinued at least 4 weeks prior to treatment in this study Subjects must either have a CA 19-9 value > the institutional ULN on two separate checks at least 2 weeks apart OR have had an R1 resection margin OR N1 nodal disease regardless of CA 19-9 level Subjects must be free of visible disease on imaging (CT, PETCT or MRI) evaluating chest, abdomen, and pelvis within 28 days of enrollment on the study Life expectancy of greater than 12 weeks Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Pregnant or breastfeeding women Use of any other chemotherapy, radiotherapy, or experimental drug or therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to enrollment on study or those who have not recovered from adverse events ≥ grade 1 due to agents administered more than 4 weeks earlier except for stable grade 2 neuropathy Subjects may not receive any other concomitant investigational agents Known or suspected hypersensitivity to 5-azacitidine or mannitol Known positive for HIV or infectious hepatitis, type B or C. HIV patients are at increased risk of lethal infections when treated with marrow-suppressive therapy Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Any known gastrointestinal disorders which would preclude oral administration of 5-azacitidine | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 45.0-80.0, Health Behavior Motor Activity Food Habits Patients who live in the catchment area of the health centers participating in the trial or that have their primary care physician in these centers. or Patients with a diagnosis of coronary heart disease, and / or transluminal angioplasty and / or coronary artery bypass grafting (CABG). These diagnoses must have occurred longer than six months from the time of inclusion. or Patients with a diagnosis of cerebrovascular accident (CVA), transient ischemic attack (TIA), carotid endarterectomy and / or carotid angioplasty. These diagnoses must have occurred longer than six months from the time of inclusion. or Patients with peripheral arterial disease with or without intermittent claudication, revascularization surgery, bypass placement of arterial and / or peripheral arterial angioplasty. These diagnoses must have occurred longer than six months from the time of inclusion. and Sedentary persons, defined as less than 90 minutes per week of moderate aerobic physical activity in their daily life (leisure, travel or work) Patients on chronic home monitoring and / or institutionalized before admission or living in a tertiary institution. or Moderate or severe limitation on functional capacity and / or mobility. or Patients with dementia. or Patients diagnosed with psychiatric illnesses that compromise patient autonomy. or Life expectancy less than 1 year. or Patients who do not want to take part in the program. or Patients who are participating in another research protocol at recruitment. or Patients with a diagnosis of intracranial hemorrhage secondary to aneurysmal rupture | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-80.0, Acute Ischemic Stroke ischemic stroke female or male gender mRS (modified Rankin Scale) 0-1 (min one month before the event) NIHSS ≥ 6 and ≤ 25 Age: 18-80 years initiation of therapy in the interval from 4.5 to 24 hours from onset of symptoms of ischemic stroke focal neurological deficit of at least 30 min, which was significantly obviously does not disappear before treatment patient will participate voluntarily and signed informed consent. Informed consent will be obtained from each patient, guardian or close relative patients who are unable to sign, but who are able to understand what means to participate in the study, may give informed consent through eyewitness willingness and ability to comply with the protocol intracranial hemorrhage confirmed by CT scan CT image heavy and extensive focal cerebral ischemia lacunar syndrome epileptic seizure at the beginning of ischemic stroke previous or planned treatment with intravenous, intra-arterial thrombolysis, mechanical recanalization or ultrasound assisted thrombolysis stroke, myocardial infarction, head trauma in the last 3 months tromboctov count below 100 000/mm ³ therapeutically uncontrolled blood pressure: systolic blood pressure> 185 mmHg or diastolic blood pressure> 110 mmHg therapeutically uncontrolled blood glucose ˂ 2.77 or> 22.15 mmol / l Known bleeding diathesis, other coagulopathies, severe hepatopathy, severe nephropathy | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 40.0-999.0, Atherosclerosis CEA Cohort Age ≥40years Scheduled to undergo CEA for clinically significant carotid stenosis CEA is being performed for carotid stenosis of one or more of the following vessels: Internal Carotid Artery (ICA), distal end of the Common Carotid Artery (CCA), and/or CCA bulb Pregnancy Prior surgery or intervention involving the carotid artery Prior stent in the carotid artery Unable to provide informed consent CEA for carotid stenosis for proximal CCA only (ICA and distal CCA are not involved) CEA is scheduled for non-atherosclerotic vascular disease (e.g.,. fibromuscular dysplasia or systemic vasculitis) Unable to understand English language. Normal Cohort Age ≥40years Pregnancy Prior surgery or intervention involving the carotid artery (including CEA) | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Carotid Artery Disease Carotid Artery Stenosis Patient is at least 18 years old at informed consent Patient is willing and capable of complying with all study protocol requirements, including specified follow-up period and can be contacted by telephone Patient is willing to provide written informed consent prior to enrollment in study Patient is either Symptomatic with carotid stenosis ≥50% as determined by angiography using methodology. Symptomatic is defined as amaurosis fugax ipsilateral to the carotid lesion; Transient Ischemic Attack (TIA) or non-disabling stroke within 180 days of the procedure within the hemisphere supplied by the target vessel; OR Asymptomatic with carotid stenosis ≥80% as determined by angiography using methodology Patient must be considered high risk for adverse events during carotid endarterectomy Note: Additional may apply Patient has life expectancy of less than one year Patient is experiencing (or has experienced) an evolving, acute, or recent disabling stroke Patient has anticipated or potential sources of emboli (e.g. atrial fibrillation, known previously symptomatic patent foramen ovale (PFO), mechanical heart valve, or Deep Vein Thrombosis (DVT) treated within 6 months) Patient has had an acute myocardial infarction within 72 hours prior to the index procedure Patient has a history of major, disabling ipsilateral stroke with residual deficit that may confound the neurological subject assessments Patient has known severe carotid stenosis contralateral to the target lesion requiring treatment within 30 days following the index procedure. Note: Additional | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 56.0-78.0, Prostate Cancer over 50 years old ASA class I or II Scheduled for robot assisted laparoscopic prostatectomy previous neurologic deficit history of psychiatric disease, alcoholism or other drug dependency Serious hearing or visual impairment or any other comorbidities which would preclude neuropsychological tests | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 40.0-999.0, Heart Failure Key 1. Chronic symptomatic Heart Failure (HF) documented by one or more of the following: 1. New York Heart Association (NYHA) Class II/III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion) at screening visit; or signs (Any rales post cough, Chest x-ray demonstrating pulmonary congestion,) within past 12 months; 2. One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify); 3. On-going management with recommended heart failure medications and comorbidities for several months according to the guidelines (2012 ESC Guidelines for diagnosis and Treatment of Acute and Chronic Heart Failure). 2. Age ≥ 40 years old 3. Left ventricular ejection fraction (obtained by echocardiography) ≥ 40% 4. Elevated left ventricular filling pressures with a gradient compared to CVP documented by : 1. PCWP or LVEDP at rest ≥ 15 mmHg, and greater than CVP, OR 2. PCWP during supine bike exercise ≥ 25mm Hg, and CVP < 20 mm Hg Key Severe heart failure defined as: 1. ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF; 2. Fick Cardiac Index < 2.0 L/min/m2 3. Requiring inotropic infusion (continuous or intermittent) within the past 6 months 4. Patient is on the cardiac transplant waiting list 4. Inability to perform 6 Minute Walk Test 5. Known significant coronary artery disease (stenosis >70%) 6. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months 7. Known severe carotid artery stenosis (> 70%) 8. Presence of significant valve disease defined by echocardiography as: a) Mitral valve regurgitation defined as grade >2+ MR b) Tricuspid valve regurgitation defined as grade ≥ 2+ TR; c) Aortic valve disease defined as ≥ 2+ AR or moderate AS | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Chronic Low Back Pain Patients with disc herniation or radiculitis who are over 18 years of age. 2. Patients with a history of chronic function-limiting low back pain and lower extremity pain for at least one months' duration. 3. Patients who are competent to understand the study and provide written informed consent and participate in outcome measurements Patients have previous lumbar surgery with metal instrument. Initial MRI shows spinal stenosis or without disc herniation. Patients have unstable opioid use, uncontrolled psychiatric disorders, uncontrolled acute medical illness, any condition that could interfere with the interpretation of outcome assessments, pregnant or lactating women or allergy to local anesthetics or steroid. Patients who are unable to perform MRI or fMRI will also be excluded | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-75.0, Cardiovascular Diseases Coronary Artery Disease Myocardial Ischemia Coronary Disease Coronary Restenosis Heart Diseases Coronary Stenosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases The recommendation to implant BVS in an individual patient in whom rotational atherectomy of a complex target lesion has been conducted, is purely based on clinical grounds. These are determined by the instructions for use (IFU) of the BVS and by the clinical experience accumulated so far from clinical studies.These studies suggest that the BVS should be implanted under certain conditions, which are determined by the patient and the coronary lesion treated: Eligible: Regarding to patient Patient ≥ 18 and ≤ 75 years with a live expectancy of at least 5 years with ischemic heart disease (chronic, and unstable angina) due to one or more complex de novo native coronary artery lesions Patients with evidence of myocardial ischemia Regarding to lesion Reference vessel diameter ≥ 2.5 mm and ≤ 3.8 mm, visually estimated or by online QCA Percent diameter stenosis ≥ 50% and < 100%, visually estimated or by online QCA TIMI ≥1 Previous interventions of target vessel lesions should have been done ≥ 6 months prior to index procedure and > 10 mm distal to the target lesion Previous interventions of non-target vessel lesions should have been done ≥ 30 days prior to index procedure Not eligible: Regarding to patient Patient in whom antiplatelet therapy and/or anticoagulant therapy is contraindicated Patient with a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, ticlopidine, prasugrel and ticagrelor, everolimus, poly (L-lactide), poly (D,L-lactide), or platinum, or with contrast sensitivity, who cannot be adequately premedicated | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, (Near) Syncope (near) syncope age < 18 years progressive impairment of consciousness use of mind-altering drugs non syncopal loss of consciousness: hyperventilation, hypoglycaemia, metabolic disorders, psychogenic pseudosyncope, TIA or stroke, seizure, transient loss of consciousness caused by craniocerebral injury | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 25.0-95.0, Ischemic Cerebrovascular Disease symptomatic ischemic cerebrovascular disease caused by Intracranial atherosclerotic atherosclerosis research database days had a stroke or transient ischemic attack is defined as symptomatic Intracranial atherosclerotic atherosclerosis stenosis ≥ 50% (MRI or CT angiography) Intracranial vascular stenosis measured according to the method reported Warfarin aspirin symptomatic intracranial disease research diffuse intracranial arterial stenosis cranial magnetic resonance imaging shows lesions as the branch artery blockage caused non-atherosclerotic lesions occurred within 6 weeks of vascular lesions in the region of intracranial hemorrhage potential cardiac thrombus source has concurrent intracranial tumors, intracranial aneurysm or arteriovenous malformation ipsilateral extracranial carotid or vertebral artery stenosis ≥ 50% known to heparin, aspirin, clopidogrel, anesthetics and contrast agents contraindications hemoglobin less than 10g/dL, platelet count <100000/dL responsibility left after cerebral vascular-related serious neurological dysfunction (mRS ≥ 3) | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Coronary Artery Disease Stroke Peripheral Arterial Disease Hypertension Diabetes Mellitus, Type 2 History of cardiovascular event (coronary carter disease, cardiovascular disease, transient ischemic attack, minor stroke peripheral artery disease , abdominal aortic aneurysm) Diabetes Mellitus type 2 Hypertension (Blood pressure>140/90 mm Hg) Known renal failure (defined as eGFR <46 ml/min/1.73 m2 estimated based on the modification of diet in renal disease (MDRD) formula) Previous allergic reaction to contrast, necessitating medical intervention Other contra-indication for CT-scanning (e.g. pregnancy, acute hypotension (<100 mm Hg systolic), clinical instability) Prior exposure to ionizing radiation for scientific purposes without advantage for the patient | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-100.0, Diabetes Mellitus Cardiovascular Disease Healthy Volunteer Inflammation Cardiovascular Disease Females and males 18 years of age or older Diagnosis of clinical CAD (including abnormal EKG with a prior infarction pattern, abnormal echo consistent with a wall motion abnormality or a referral note from cardiologist with diagnosis of CAD) CAD that is currently stable (defined by no change in medications for blood pressure, angina or diuretic therapy or in no new CV symptoms over the past month in a patient who has had a primary cardiac event or an abnormal EKG with confirmed wall motion abnormality) CAD which may be associated with chronic stable angina (defined by a clinical syndrome characterized by discomfort in the chest, jaw, shoulder, back, or arm by a physician) CAD that is found on CCTA which may be subclinical Pregnant women or lactating women For optional adipose biopsy, any subject with known bleeding disorder, current fever or on anti-coagulation For optional MRI, inability to participate due to metal within body, claustrophobia, or anything else that prohibits undergoing a MRI scan Any solid organ or liquid tumor within the past five years, with the exception of nonmelanomatous skin cancer Active infectious diseases within 3 months requiring antibiotics, collagen vascular diseases such as RA, psoriasis and mixed connective tissue diseases and immune-mediated lung diseases (e.g. IPF, BOOP) A BMI >40 kg/m(2) due to PET MRI restrictions Subjects with severe renal excretory dysfunction, estimated glomerular filtration rate < 30 mL/min/1.73m(2) body surface area according to the Modification of Diet in Renal Disease will not receive the cardiac CT angiography, or gadolinium contrast agent during the PET/MRI Subjects with second -or third-degree AV block or sinus node dysfunction will not receive the 13N-ammonia PET/CT imaging unless these patients have a functioning artificial pacemaker Subjects with any signs or symptoms of acute coronary syndrome, including vasoreactive hypertension with blood pressure exceeding 180/100, any concerning ST segment changes on ECG, or acute chest pain, will not receive the 13N-ammonia PET/CT imaging. Diabetes Mellitus Females and males 18 years of age or older | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Painful Myelopathy Painful Neuropathy Men or women 18 years or older. 2. Neuropathic pain due to peripheral neuropathy or myelopathy 3. Duration of condition greater than 6 months 4. Inadequate control with trials of three or more analgesic agents considered standard care for treatment of neuropathic pain; treatment failure can be either due to lack of efficacy or to intolerable side effects. 5. Documented normal CK and GFR within 6 months preceding screening. 6. Baseline BPI pain severity subscale score of >5/10 Renal insufficiency 2. History of Myopathy or persistently elevated CK levels 3. History of prior suicide attempt or ideation 4. History of Psychosis 5. Pregnancy or breastfeeding 6. Inability or unwillingness to use contraception 7. Inability to provide consent 8. Inability to tolerate lumbar punctures 9. Receiving systemic anticoagulation therapy (eg. Coumadin) 10. Inability/unwilling to self-catheterize if indicated 11. Change (start, stop, adjust) in home medications 30 days prior to screening visit. 12. Baseline CES-D score > 30 13. Subject has previously failed ziconotide treatment 14. Other factors that in the opinion of the PI would the subject from participation in the study | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Breast Cancer Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship) | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-65.0, Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 months | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/dL | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.0-999.0, Blood Pressure Depression Panic Attack Fibromyalgia POTS Inappropriate Sinus Tachycardia Coronary Heart Disease Acute Coronary Syndrome (ACS) Acute Myocardial Infarction (AMI) Cerebrovascular Disease (CVD) Transient Ischemic Attack (TIA) Atrial Fibrillation Diabetes Mellitus Cancer Systolic Heart Failure Diastolic Heart Failure Chronic Fatigue Syndrome Syncope Vasovagal Syncope Any patient regardless of the age of gender Any non-correctable secondary cause of increase or decrease in blood pressure or a pathology that alters the prognosis before the entrance of the patient into this registry nephropathy prior to the admission familial dyslipidemia previous gastric bypass pre-existing heart failure chemotherapy-induced cardiotoxicity arrhythmogenic right ventricular dysplasia long QT syndrome hypertrophic cardiomyopathy | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Peripheral Arterial Diseases Intermittent Claudication Age ≥ 18 years old Insured under the French social security system (according to French law) Presence of lower-extremity peripheral artery disease, defined by A resting ankle-brachial index (ABI) ≤ 0.90 OR if resting ABI > 0.90 and < 1.00, a decrease in recovery ankle systolic pressure or in recovery ABI from treadmill exercise higher than 30% or 20%, respectively (AHA recommendations) OR if resting ABI > 1.40, a toe pressure index ≤ 0.70 Maximal walking distance on treadmill (3.2 km/h, 10% grade) < 500m (a) Complain of exertional lower limbs pain that can begin or not at rest, causes the participant to stop walking and relieves or lessens within 10 minutes of rest (assessed using the San Diego questionnaire AND confirmed during treadmill testing) (b) 1. As assessed during the medical appointment. 2. According to our patients' leg symptoms that fell within the following leg symptom categories could be included in the study: i) Intermittent claudication. Patients that experience exertional calf pain that does not begin at rest and that forces them to stop walking and that relieves or lessens within 10 minutes of rest; ii) Atypical exertional leg pain/stop. This category can encompass diverse situations of exertional leg symptoms. In the present study, patients in this category were included if they experience exertional pain that does not begin at rest and that forces them to stop walking, but that do not involve only the calf(s) but also thigh(s) and/or buttock(s). Further, the exertional leg pain relieves or lessens within 10 minutes of rest; iii) Leg pain on exertion and rest. In this category, patients sometimes experience exertional leg pain at rest when they are standing still or sitting. On exertion, patients also experience a walking pain as described above. As reminded by Criqui et al., this category of patients with "pain at rest" should not be confused with patients that experience "rest pain", which usually refers to patients with such severe advanced PAD that ischemic pain is present even at rest. Patients with ischemic rest pain were not included in the study. Non-Inclusion Exercise limitation due to symptoms not related to an arterial insufficiency in the lower limbs (e.g., dyspnea, angina pectoris) Contraindication for walking (Abdominal aortic aneurysm > 4 cm) | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Chronic Low Back Pain Age 18 or older Patient with Chronic Low Back Pain Meets minimum pain level Ability to perform the experimental Task and Procedures MRI contraindication if an MRI exam is required per protocol TMS Contraindication History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher Neurologic illness that would interfere with brain integrity Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher Currently pregnant or planning to become pregnant On going legal action or disability claim | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-85.0, Stroke Able to provide informed consent Within 6-12 months of diagnosis of single ischemic or hemorrhagic stroke, confirmed with neuroimaging Fugl-Meyer Motor Score 19-55 in involved upper extremity Approval from patient's primary care physician Age between 18 and 85 years Hospitalization for myocardial infarction, congestive heart failure, or heart surgery (CABG or valve replacement) within 3 months of study enrollment Serious cardiac arrhythmia Hypertrophic cardiomyopathy Severe aortic stenosis Cardiac pacemaker Pulmonary embolus Other medical or musculoskeletal contraindication to exercise Significant cognitive impairment (unable to follow 1-2 step commands) or major psychiatric disorder (major depression, generalized anxiety) that will cause difficulty in study participation Anti-spasticity injection (botox) in upper extremity within 3 months of study enrollment Pregnancy | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.0-999.0, Coronary Artery Disease Chronic Total Occlusions Patient with angiographic diagnosis of significant CAD registered in SCAAR between January 2005 and january 2012 Previous CABG surgery Missing data on coronary anatomy Patients who underwent a procedure for ACS in whom the 100% occlusion was located in the same coronary artery as the culprit vessel Patients who underwent a procedure in the same vessel within the previous 3 months | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Head and Neck Neoplasms Malignant Neoplasm of Vertebral Column Participants must meet the following on screening examination to be eligible to participate in the study Participants must have histologically confirmed malignant tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective Participants with malignant locally recurrent and/or metastatic tumors will be eligible for cryoablation. All tumor shapes and sizes will be eligible for ablation Participants must have sustained all available treatment options (radiation, chemotherapy, surgery) as verified by the Dana Farber Cancer Institute's Head and Neck Tumor Board. These cases will be reviewed by a team of medical oncologists, radiologists, radiation oncologists, and surgical oncologists Participants must have an advanced head, neck or spine malignant tumor that would potentially benefit from a minimally invasive procedure Age 18 years or older - Because no dosing or adverse event data are currently available on the use of cryoablation in participants < 18 years of age, children are excluded from this study but will be eligible for future pediatric III trials Life expectancy of greater than 8 weeks in the opinion of the referring clinician Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix A) Participants must have normal organ and marrow function as defined below Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study Participants with tumors involving the optic chiasm, brain, or spinal cord will not be eligible for participation in this study. Furthermore, tumors that encase any major blood vessel (carotid, jugular, vertebral) will be excluded from the study due to inability to displace these masses Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier Participants may not be receiving any other study agents Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events History of allergic reactions attributed to compounds of similar chemical or biologic composition to gadolinium contrast agents, if contrast use is anticipated during the procedure Participants with a blood glucose level of > 200mg/dl prior to the baseline study, known ischemic disease, and/or impaired renal function (eGFR < 60ml/min) will not be eligible for this study Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women are excluded from this study because gadolinium is a contrast agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with gadolinium, breastfeeding should be discontinued if the mother is treated with gadolinium MRI-Guided Cryoablation | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 35.0-999.0, Carotid Stenosis General 1. Patients ≥35 years old. 2. Carotid stenosis defined as Stenosis ≥70% by catheter angiography (NASCET Criteria); OR by DUS with ≥70% stenosis defined by a peak systolic velocity of at least 230 cm/s plus at least one of the following: 1. an end diastolic velocity ≥100 cm/s, or 2. internal carotid/common carotid artery peak systolic velocity ratio ≥4.0, or 3. CTA with ≥ 70% stenosis, or 4. MRA with ≥ 70% stenosis. 3. No medical history of stroke or TIA ipsilateral to the stenosis within 180 days of randomization. Life-long asymptomatic patients will be defined as having no medical history of stroke or transient ischemic attack and negative responses to all of the symptom items on the Questionnaire for Verifying Stroke-free Status (QVSS).18 4. Patients must have a modified Rankin Scale score of 0 or 1 at the time of informed consent. 5. Women must not be of childbearing potential or, if of childbearing potential, have a negative pregnancy test prior to randomization. 6. Patients must agree to comply with all protocol-specified follow-up appointments. 7. Patients must sign a consent form that has been approved by the local governing Institutional Review Board (IRB)/Medical Ethics Committee (MEC) of the respective clinical site. 8. Randomization to treatment group will apply to only one carotid artery for patients with bilateral carotid stenosis. Management of the non-randomized stenosis may be done in accordance with local PI recommendation. Treatment of the non-study internal carotid artery must take place at least 30 days prior to randomization, or greater than 44 days after randomization and 30 days after the study procedure is completed (whichever is longer). 9. Carotid stenosis must be treatable with CEA, CAS, or either procedure. General Intolerance or allergic reaction to a study medication without a suitable management alternative. 2. GI hemorrhage within 1 month prior to enrollment that would preclude antiplatelet therapy. 3. Prior major ipsilateral stroke in the past with substantial residual disability (mRS ≥ 2) that is likely to confound study outcomes. 4. Severe dementia. 5. History of major symptomatic intracranial hemorrhage within 12 months that was not related to anticoagulation. 6. Prior Intracranial hemorrhage that the investigator believes represents a contraindication to the perioperative or periprocedural antithrombotic and antiplatelet treatments necessary to complete endarterectomy or stenting per protocol. 7. Current neurologic illness characterized by fleeting or fixed neurologic deficits that cannot be distinguished from TIA or stroke. 8. Patient objects to future blood transfusions. 9. Platelet count <100,000/microliter or history of heparin-induced thrombocytopenia. 10. Anticoagulation with Phenprocoumon (Marcumar®), warfarin, or a direct thrombin inhibitor, or anti-Xa agents. 11. Chronic atrial fibrillation. 12. Any episode of atrial fibrillation within the past 6 months or history of paroxysmal atrial fibrillation that is deemed to require chronic anticoagulation. 13. Other high-risk cardiac sources of emboli, including left ventricular aneurysm, severe cardiomyopathy, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area < 1.0 cm2), endocarditis, moderate to severe mitral stenosis, left atrial thrombus, or any intracardiac mass, or known unrepaired PFO with prior paradoxical embolism. 14. Unstable angina defined as rest angina with ECG changes that is not amenable to revascularization (patients should undergo planned coronary revascularization at least 30 days before randomization). 15. Left Ventricular Ejection fraction <30% or admission for heart failure in prior 6 months. 16. Respiratory insufficiency with life expectancy < 4 years or FEV1 <30% of predicted value. 17. Known malignancy other than basal cell non-melanoma skin cancer. There are two exceptions to this rule: patients with prior cancer treatment and no recurrence for >5 years are eligible for enrollment and cancer patients with life expectancy of greater than 5 years are eligible for enrollment. 18. Any major surgery, major trauma, revascularization procedure, or acute coronary syndrome within the past 1 month. 19. Either the serum creatinine is ≥ 2.5 mg/dl or the estimated GFR is < 30 cc/min. 20. Major (non-carotid) surgery/procedures planned within 3 months after enrollment. 21. Currently listed or being evaluated for major organ transplantation (i.e. heart, lung, liver, kidney). 22. Actively participating in another drug or aortic arch or cerebrovascular device trial for which participation in CREST-2 would be compromised with regard to follow-up assessment of outcomes or continuation in CREST-2. 23. Inability to understand and cooperate with study procedures or provide informed consent. 24. Non-atherosclerotic carotid stenosis (dissection, fibromuscular dysplasia, or stenosis following radiation therapy). 25. Previous ipsilateral CEA or CAS. 26. Ipsilateral internal or common carotid artery occlusion. 27. Intra-carotid floating thrombus. 28. Ipsilateral intracranial aneurysm > 5 mm. 29. Extreme morbid obesity that would compromise patient safety during the procedure or would compromise patient safety during the periprocedural period. 30. Coronary artery disease with two or more proximal or major diseased coronary arteries with 70% stenosis that have not, or cannot, be revascularized. Specific carotid endarterectomy Patients who are being considered for revascularization by CEA must not have any of the following 1. Serious adverse reaction to anesthesia not able to be overcome by pre-medication. 2. Distal/intracranial stenosis greater than index lesion. 3. Any of the following anatomical: radical neck dissection; surgically inaccessible lesions (e.g. above cervical spine level 2 (C2)); adverse neck anatomy that limits surgical exposure (e.g. spinal immobility inability to flex neck beyond neutral or kyphotic deformity, or short obese neck); presence of tracheostomy stoma; laryngeal nerve palsy contralateral to target vessel; or previous extracranial-intracranial or subclavian bypass procedure ipsilateral to the target vessel. Specific Carotid Artery Stenting Patients who are being considered for revascularization by CAS must not have any of the following 1. Allergy to intravascular contrast dye not amenable to pre-medication. 2. Type III, aortic arch anatomy. 3. Angulation or tortuosity (≥ 90 degree) of the innominate and common carotid artery that precludes safe, expeditious sheath placement or that will transmit a severe loop to the internal carotid after sheath placement. 4. Severe angulation or tortuosity of the internal carotid artery (including calyceal origin from the carotid bifurcation) that precludes safe deployment of embolic protection device or stent. Severe tortuosity is defined as 2 or more ≥ 90 degree angles within 4 cm of the target stenosis. 5. Proximal/ostial CCA, innominate stenosis or distal/intracranial stenosis greater than index lesion. Excessive circumferential calcification of the stenotic lesion defined as >3mm thickness of calcification seen in orthogonal views on fluoroscopy.(Note: Anatomic considerations such as tortuosity, arch anatomy, and calcification must be evaluated even more carefully in elderly subjects (≥ 70 years).) 6. Target ICA vessel reference diameter <4.0 mm or >9.0 mm. Target ICA measurements may be made from angiography of the contralateral artery. The reference diameter must be appropriate for the devices to be used. 7. Inability to deploy or utilize an FDA-approved Embolic Protection Device (EPD). 8. Non-contiguous lesions and long lesions (>3 cm). 9. Qualitative characteristics of stenosis and stenosis-length of the carotid bifurcation (common carotid) and/or ipsilateral external carotid artery, that preclude safe sheath placement. 10. Occlusive or critical ilio-femoral disease including severe tortuosity or stenosis that necessitates additional endovascular procedures to facilitate access to the aortic arch or that prevents safe and expeditious femoral access to the aortic arch. "String sign" of the ipsilateral common or internal carotid artery. 11. Angiographic, CT, MR or ultrasound evidence of severe atherosclerosis of the aortic arch or origin of the innominate or common carotid arteries that would preclude safe passage of the sheath and other endovascular devices to the target artery as needed for carotid stenting | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 60.0-999.0, Delirium Postoperative Cognitive Deficit (POCD) Study Group: 1. Patients aged ≥ 60 years 2. Male and female patients undergoing elective cardiac (elective CABG-surgery without valve surgery with left ventricular ejection fraction ≥ 30%) or pancreatic or hepatic or gastric or intestinal surgery of both Campus Charité Mitte and Campus Virchow - Klinikum, Charité Universitätsmedizin Berlin 3. Offered patient information and written consent by the patient (according to German Drug Law § 40 (1) 3b) 4. Premedication only with benzodiazepines 5. Pain therapy during the operation with regional procedures and/or Sufentanil/Fentanyl 6. Anesthesia in cardio surgery according to Heart-Lung-Apparatus 7. Anesthesia with hypnotic agent Propofol 8. Pain therapy after operation according to S3-Guideline 9. Postoperative medication for anxiolysis only with benzodiazepines Known drug intolerance/allergy: dexmedetomidine or to other ingredients 2. Lacking willingness to save and hand out pseudonymised data within the clinical trial 3. Accommodation in an institution due to an official or judicial order (according to AMG §40 (1) 4) 4. Employee of the Charité Universitätsmedizin Berlin CVK/CCM 5. Illiteracy 6. Inability to speak and/or read German 7. Minimal mental status examination (MMSE) < 24 8. Severe hearing loss or visual impairment 9. Acute brain injury 10. Intracranial haemorrhage within one year before participation in the study 11. Manifest psychiatric disease 12. Known illicit substance abuse 13. Acute intoxication 14. For women: Pregnancy or positive pregnancy test within the preoperative screening 15. Homeless or other circumstances, where the patient would not be reachable by telephone or postal services for the 3-months follow up 16. Participation in another interventional clinical trial according to the German Drug Law at time of and during the trial 17. Acute circulatory failure at time of randomisation (severe hypotension with mean arterial pressure < 55 mmHg despite vasopressors or optimal preload) 18. AV-conduction-block II or III (unless pacemaker installed) 19. Severe bradycardia (heart-rate < 50 bpm, preoperative, permanent) 20. Spinal cord injury with known autonomic dysregulation 21. Preoperative acute cerebrovascular event with neurologic residues 22. Liver insufficiency (Child C cirrhosis, MELD Score > 17) 23. Application of Remifentanil during the operation 24. Deep sedation (RASS, -4 to -5) 25. Administration of Clonidine during administration of the study drug 26. Additional administration of Dexmedetomidine within 3 months after study Control Group: 1. Patients aged ≥ 60 years of European descent (Caucasian) 2. Male or female patients with ASA II+III 3. ASA II+III-patients, for which no operation is planned within the next year 4. No operation in the last half year before study 5. Offered patient information and written informed consent Minimal mental status examination (MMSE) < 24 2. Missing informed consent for saving and hand out pseudonymous data 3. Neuropsychiatric morbidity, which limits the conduction of the neurocognitive testing 4. Anacusis or Hypoacusis, which limits the conduction of the neurocognitive testing 5. Taking psychothropic drugs (including sleep-inducing drug and benzodiazepine) on a regular basis and other substances, which limit the conduction of the neurocognitive testing | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 16.0-55.0, Concussion Subject has a diagnosis of mTBI resulting from an injury that meets the following 1. Occurred within 24 hours of Screening and was associated with a clear mechanism of injury and an alteration of consciousness (e.g., confusion, feeling dazed, or "seeing stars") 2. Was associated with a GCS score of 13-15 3. Was associated with 1 or more of the following signs and symptoms, as determined by a qualified clinician: i. Headache ii. Loss of consciousness iii. Post traumatic amnesia iv. Retrograde amnesia v. Difficulty concentrating vi. Balance problems vii. Dizziness viii. Visual problems ix. Personality changes x. Fatigue xi. Sensitivity to light/noise xii. Numbness xiii. Nausea xiv. Vomiting d. Current symptoms associated with the mTBI are causing clinically significant impairment 2. Subject is 16 to 55 years old. 3. Subject has a CGI-S score of ≥3 at Screening 4. Subject has an RPQ-3 score of ≥3 at Screening 5. Subjects who are taking psychotropic medications must have been receiving a stable regimen (i.e., same dosage and regimen) for at least 4 weeks prior to Screening. For the purposes of this protocol, psychotropic medications are defined as medications that are prescribed for intended CNS benefits. Medications for headache are permissible, as needed, according to approved prescribing information. 6. Women of child-bearing potential must have a negative urine pregnancy test at Screening. Men and women must agree to use a contraceptive method with <1% success rate (e.g., oral contraceptive, injectable progestogen, levonorgestrel implant, estrogenic vaginal ring, percutaneous contraceptive patch, intrauterine device [IUD], surgical sterilization, or double barrier method [i.e., condom with diaphragm or spermicidal agent]) Subjects are ineligible for the study if they meet any of the following Subject has a history of brain surgery or prior severe TBI (based on a previously documented GCS score of ≤8). 2. Subject has a history of seizure disorder or has experienced seizures in the 24 hours preceding Screening. Note: Isolated febrile seizures during early childhood are not exclusionary. 3. Subject has a history of diabetes mellitus requiring pharmacotherapy within the preceding 12 months. 4. Subject has a history of hypothyroidism within the 3 years preceding Screening that currently requires or did require pharmacotherapy. 5. Subject has regularly used more than 1 of the following psychoactive medications in the 4 weeks preceding Screening: methylphenidate, dextroamphetamine, mixed amphetamine salts, amantadine, memantine, cholinesterase inhibitors, modafinil, or armodafinil. 6. Subject has a history of substance abuse or dependence, other than nicotine dependence, within the 3 months preceding Screening. 7. Subject has signs/symptoms of acute impairment due to alcohol use. 8. Subject has used anti-epileptic medications in the 4 weeks preceding Screening. 9. Subject has used bromocryptine, levodopa, ropinirole, or pramipexole in the 4 weeks preceding Screening. 10. Subject has a history of a major psychiatric disorder (including major depression, a clinically significant anxiety disorder, or a psychotic disorder) that is associated with significant clinical impairment within the preceding 6 months. 11. In the Investigator's opinion, the subject poses a current homicidal or serious suicidal risk, and/or has made a suicide attempt within the 6 months preceding Screening. 12. Subject has a neurological disorder other than mTBI (e.g., Parkinson's disease, stroke, multiple sclerosis, dementia, delirium, infectious encephalopathy) that has required treatment within the 6 months preceding Screening. 13. Subject has a history of, or current, cerebrovascular disease. 14. Subject has a history of, or current, malignancy. 15. Subject has an unstable medical disorder that may pose a safety concern or interfere with the accurate assessment of safety or efficacy. 16. Subject has laboratory values at Screening deemed to be clinically significant by the Investigator. 17. Subject has an average QT interval corrected using Fridericia's formula (QTcF) >450 msec at Screening or any ECG abnormality that may pose a potential safety concern. 18. Subject has a history of risk factors for torsade de pointes (e.g., heart failure, clinically significant hypokalemia, a serum potassium value at Screening of <3.0 mmol/L, or a family history of long QT syndrome). 19. Subject has a history of QT/QTcF prolongation previously or currently controlled with medication, in which normal QT/QTcF intervals could or can only be achieved with medication. 20. Subject has participated in another clinical treatment study within the 4 weeks preceding Screening. 21. Subject is unable to provide informed consent (where deemed cognitively able by standard assessments) or informed consent cannot be obtained from a legally authorized individual (e.g., spouse, or in the instance of minors, a parent). 22. Subject is pregnant or nursing. 23. Subject was previously enrolled in this study. 24. Subject has an allergy to strawberries | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 21.0-999.0, Coronary Disease Coronary Stenosis Age ≥ 21 years with angina and/or evidence of myocardial ischemia Three vessel CAD, defined as ≥ 50% diameter stenosis by visual estimation in each of the three major epicardial vessels or major side branches, but not involving left main coronary artery, and amenable to revascularization by both PCI and CABG as determined by the Heart Team. Patients with a non-dominant right coronary artery may be included if only the left anterior descending artery (LAD) and left circumflex have ≥50% stenosis Willing and able to provide informed, written consent Requirement for other cardiac or non-cardiac surgical procedure (e.g., valve replacement, carotid revascularization) Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support Recent STEMI (<5 days prior to randomization) Ongoing Non STEMI with biomarkers (cardiac troponin) still rising Known left ventricular ejection fraction <30% Life expectancy < 2 years Requiring renal replacement therapy Undergoing evaluation for organ transplantation Participation or planned participation in another clinical trial, except for observational registries Pregnancy | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Carotid Stenosis Patients with asymptomatic (defined as no symptoms in past 6 months) carotid stenosis Patients with hemodynamically significant carotid artery stenosis (according to CREST ≥ 60% by angiography, OR ≥ 70% by ultrasound, OR ≥ 80% by CTA or MRA) Patients with prior large vessel infarct Patients with intracranial stenosis Patients with major depression Patients with Alzheimer disease (clinically defined or Wechsler IQ <80) Patients who have had previous ipsilateral carotid surgery Patients with baseline dementia defined as: Mini-Mental Status Examination score < 21 OR Mini-Mental score ≥21 AND Baseline HVLT scores more than 3 standard deviations below normal or FAS scores more than 2 standard deviations below normal OR other clinical symptoms that were not as evident on direct cognitive assessment (e.g. sundowning, getting lost while driving). Note: A control group would be comprised of about 15 patients who meet as above, but elect to have their condition followed rather than undergo revascularization | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Atherosclerosis Carotid Artery Disease asymptomatic stenosis of internal carotid artery >70% symptomatic stenosis of internal carotid artery >60% planed surgical treatment of the stenosis pregnancy symptomatic coronary heart disease myocardial infarction or acute coronary syndrome in the past 3 months acute peripheral artery occlusion in the past 3 months immaturity existence of a guardianship | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-75.0, Aneurysmal Subarachnoid Hemorrhage Cerebral Vasospasm Male and female older than 18 years of age and no more than 75 years of age. 2. aSAH patients with secured aneurysm. 3. Patient has cerebral vasospasm and is anesthetized and intubated. 4. Cerebral vasospasm is manifested by Mean Flow Velocity (MFV) >120 cm/sec in the intracranial ICA (Internal carotid artery), MCA (middle cerebral artery) or ACA (anterior cerebral artery) or MFV >110 cm/sec in the PCA, or >85 cm/sec in the vertebral or basilar arteries, as measured by TCD (Trans Cranial Doppler). Or Extra/intracranial ratio for the carotid watershed (MCA, ACA, intracranial ICA)>3, or a proximal/distal ratio for the vertebrobasilar (VB) system > 2. Or Affected/contralateral MCA MFV ratio ≥1.5. Or Affected / baseline MCA MFV ratio ≥1.5. AND Vasoconstriction of at least 33% in at least one of the main cerebral arteries, measured by Angiography (Digital Subtraction Angiography (DSA) or Computed Tomography Angiography (CTA). 5. Hemodynamically stable, including subjects who are treated for fever, hydrocephalus, rebleeding, infection or metabolic abnormalities and are stable. 6. For pre-menopausal females a negative pregnancy test, using an accepted method of birth control and avoid breast feeding for the duration of the trial 7. A legally Authorized representative have signed informed consent WFNS score 5 2. Unsecured aneurysm or Intracranial/SAH of other than aneurysmal origin. 3. Signs attributable to serious aneurismal surgical procedure-related complications. 4. Patient underwent decompressive craniectomy. 5. S/p Carotid Endarterectomy, or other neck intervention. 6. Known carotid body tumor, past or present. 7. Hemodynamic instability due to cardiac arrhythmia or due to any other cause. 8. Had a myocardial infarction, unstable angina or syncope, congestive heart failure that require hospitalization or ejection fraction ≤ 40% within the past 3 months. Note: Elevated Troponin is expected after aSAH and will not patients. 9. Had a stroke, within the past 1 year or transient ischemic attack at the last 3 months. 10. Any anatomical variation or thrombotic finding that according to the physician judgment is not eligible. 11. Renal insufficiency (Creatinine X2 of the normal). 12. Allergic to contrast media with no response to steroid pretreatment. 13. Are unable or unwilling to fulfill the protocol follow-up requirements 14. Are enrolled in another concurrent clinical trial, without prior approval of Samson NS and the PI. 15. Have an uncontrolled comorbid medical condition that would adversely affect their health if they are enrolled | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Kidney Transplantation Kidney transplant patient for whom renal biopsies are stored in the "collection of the University Hospital Toulouse" (collection N° DC-2009-989) and who received information on the purpose of the study, use of biopsies and who has not manifested any opposition Kidney transplant patient with iterative biopsies with at least: post-surgery biopsy D0 (or early post-transplant biopsy D7 and at least one biopsy protocol Age> 18 years Case group Kidney transplant patient, followed up by "organ transplant unity" of CHU Toulouse, with antecedent of CMR progressing to CTG between 2006 and 2013. Control group Kidney transplant patient, followed up by "organ transplant unity" of CHU Toulouse, with antecedent of CMR without progressing to CTG between 2006 and 2013 patient with uncontrolled hypertension patient with diabetes mellitus - patient treated or who was treated with mTOR inhibitor recurrence of the initial glomerular pathology de novo glomerulopathy patient including in another study with an period still going | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.577-0.865, Human Development Normal infants of both genders 2. Any race or ethnicity 3. Inborn preterm delivered from 30-45 weeks gestation 4. Medically stable for transport i.e. requiring at most a nasal canula < 2 liters for respiratory support Infants not delivered from 30-45 weeks gestation 2. Infants who may have a neurological event at birth 3. Presence of known or suspected congenital anomalies such as chromosomal anomalies 4. Major congenital heart disease or congenital infection 5. Substance abuse and any grade>1 of intraventricular hemorrhage (IVH) by cranial ultrasound 6. Presence of cystic periventricular leukomalacia (PVL) by cranial ultrasound | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.0-999.0, Cataract Surgery Patients with age-related cataract scheduled for elective phacoemulsification and intraocular lens implantation for the first time in Department of Ophthalmology, Affiliated Hospital of Guangdong Medical College will be recruited in this study. Recruited patients shall own normal intelligence and understanding capability and their best corrected visual acuity more than 0.1 in either eye Patients who have undergone previously cataract surgery or whose best corrected visual acuity is lower than 0.1 in either eye or patients who complicated with complex other eye diseases such as uveitis and retinal detachment or patients whose language is not cantonese or mandarin will be excluded from this study | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-90.0, Tennis Elbow Patients eligible for in the study will have had symptoms for at least 9 months and have failed conservative management Significant prior elbow trauma will be excluded alternative diagnoses that better explain their symptoms Patients who have had significant prior elbow trauma or surgery WSIB patients | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Carotid Stenosis Coronary Stenosis indication for carotid endarterectomy no clinical sign or history of ischemic heart disease no electrical signs of cardiac ischemia left ventricular ejection fraction >50% at transthoracic echocardiogram disabling stroke (mRS ≥3) non atherosclerotic carotid disease severe intracranial carotid artery stenosis contra-indications to heparin, aspirin or clopidogrel | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 0.0-999.0, Knee Osteoarthritis Joint Diseases Have a physician confirmed diagnosis of knee osteoarthritis OR are both 1) over 50, and 2) have experienced 4 weeks of pain, aching, or discomfort in or around the knee during the last year (equal to or more than 28 separate or consecutive days) Have no previous diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polymyalgia rheumatica, connective tissue diseases, fibromyalgia or gout Have no history of using disease-modifying anti-rheumatic drugs or gout medications Have no prior knee replacement surgery, and not on a waiting list for total knee replacement surgery Have no history of acute injury to the knee in the past 6 months Have not had surgery in the back, hip, knee, foot or ankle joints in the past 12 months Have an email address and daily access to a computer with internet connection Be able to attend a 2-hour education session at the Mary Pack Arthritis Centre Have a body mass index of equal to or greater than 40 Have received a steroid injection in a knee in the last 6 months Have received a hyaluronate injection in a knee in the last 6 months Use medication that may impair activity tolerance (e.g. beta blockers) Are at risk when exercising, as identified by the Physical Activity Readiness Questionnaire (PAR-Q) | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Multivessel Coronary Artery Disease Patient age ≥18 years Patient with symptomatic stable CAD or silent ischemia, with 3-vessel disease and/or significant stenosis of left main coronary artery on angiography, with significant ischemia evaluated in stress CMR Patient suitable for both PCI or CABG after local heart team evaluation Patient understands and accepts the meaning and the aims of the study and is willing to sign written informed consent Prior CABG Concomitant valve disease requiring cardiac surgery Metal implants that may be the contraindication for CMR examination (e.g. peacemaker, ICD) Other contraindication for stress CMR or computed tomography (claustrophobia, asthma, a-v bloc, allergy to radiographic contrast or any prior anaphylaxis to contrast) Contraindication for 12 months dual antiplatelet therapy (DAPT) or known allergy to acetylsalicylic acid, clopidogrel or ticagrelor Female patient with child bearing potential Acute coronary syndrome within 2 weeks prior to revascularization Significant stenosis of any vessel, including LM if reference diameter > 4mm left ventricular ejection fraction (LVEF) <35% Life expectancy < 12 months | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-85.0, End Stage Renal Disease Vascular Access Patency Patients on chronic hemodialysis with a functioning arterio-venous fistula Recent history of bleeding over the last 3 months preceding enrollment History of bleeding disorder (hemophilia, Von Willebrandt disease, etc….) Recent history of blood transfusion over the last 3 months preceding enrollment Recent serious injury or surgery over the last 3 months preceding enrollment History of gastro-intestinal ulcers Moderate-severe hepatic impairment Uncontrolled blood pressure (SBP> 200 or DBP >110) post dialysis History of stroke Pregnant females-self reported Hypersensitivity to Aspirin /antiplatelets | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 25.0-90.0, Carotid Artery Thrombosis Carotid Artery Stenosis Stroke Carotid stenosis > 60% Redo carotid surgery Radiation induced carotid stenosis Extensive carotid lesion > 5 cm in length with involvement of the common carotid artery best treated by a carotid bypass | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Hyperlipidemia Hypercholesterolemia Cardiovascular Disease Diabetes Chronic Kidney Disease (CKD) Hypertension Smoking Myocardial Infarction (MI) Unstable Angina Angina Coronary Artery Disease (CAD) Stroke Transient Ischemic Attack (TIA) Carotid Stenosis Peripheral Arterial Disease Atherosclerosis Claudication Prior evidence of clinical atherosclerotic cardiovascular disease (ASCVD) which can any of the following Hospitalization for acute myocardial infarction or unstable angina Coronary revascularization or chronic coronary artery disease with or without angina Other arterial (carotid, abdominal, renal or lower extremity) revascularization (e.g., surgical bypass, percutaneous intervention, arterial vascular reconstruction, abdominal aortic aneurysm repair, excluding dialysis fistulas or arteriovenous grafts) Ischemic stroke or transient ischemic attack (TIA) Imaging evidence of > 70% diameter stenosis in any carotid artery or clinical documentation of severe carotid stenosis Peripheral arterial disease secondary to atherosclerosis (e.g., aortic aneurysm, ankle brachial index <0.9, imaging evidence of >50% diameter stenosis in any peripheral artery, or claudication) 2. Currently on statin therapy 3. Low density lipoprotein cholesterol (LDL-C) level ≥ 130 mg/dL within the last 2 years (treated or untreated) 4. Age ≥ 65 years 5. Age ≥ 40 years with at least 1 of the following Diabetes Chronic Kidney Disease (CKD), defined as eGFR <60 ml/min or documented stage III or higher CKD year ASCVD risk ≥ 5% (per the 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk) Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (reading or comprehension) 2. Anticipated life expectancy less than 6 months 3. Participation in any clinical trial involving a medical treatment at the time of enrollment | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 2.0-8.0, Healthy Children 2 through 8 years of age Healthy body weight for age Regular use of vitamin D supplements Lactose intolerant Don't drink milk or eat cheese or yogurt Prior treatment for biochemically confirmed vitamin D deficiency Known or suspected medical conditions associated with bone and vitamin D including rickets, osteomalacia, liver disease, renal disease, immobilization (complete or partial), fractures, and disorders of the parathyroid gland Known or suspected chronic illness of childhood, such as asthma, cancer, Crohn's disease, nephrotic syndrome, rheumatic conditions, and diabetes, etc Use in the past 3 months of medications known to affect bone and/or mineral ion metabolism including oral/systemic/inhaled glucocorticoids, phosphate therapy or vitamin D analogues. Bisphosphonates are also included in this category however, because of their long-half lives and persistence in bone tissue, any prior use of bisphosphonate therapy precludes enrolment Conditions in which the procurement of 8 ml of blood would compromise the health of the patient (i.e. patients with severe anemia) | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 40.0-85.0, Internal Carotid Artery Stenosis Subject has a symptomatic or asymptomatic ICA stenosis ≥ 70 % (NASCET criteria) as detected by a duplex sonography (see Appendix) and confirmed using the computed tomography angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography (DSA) Subject is indicated for CEA according to the set by the American Heart Association Subject is aged 40 years Subject has a sufficient temporal bone window for TCD with detectable blood flow in the MCA Subject is functionally independent with a modified Rankin score value of 0 points Informed consent is signed by the subject Subject has been participating in another clinical trial within last 6 weeks Subject has any other medical condition that would make him/her inappropriate for study participation, in the Investigator opinion | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 20.0-999.0, Cerebrovascular Diseases Stroke Cardiovascular Diseases CVD Risk Factors At high risk of stroke Already suffered a stroke or Transient Ischemic Attack (TIA) or At least two risk factors for stroke High blood pressure Overweight Low physical activity Smoking Unhealthy diet Inability to fill out or to understand the informed consent No signed informed consent Dementia | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-80.0, Arthroplasty, Replacement, Knee Pain, Postoperative The subject is scheduled for elective unilateral TKA 2. The subject is ≥ 18 years and ≤ 80 years; 3. The subject's weight is between 70-120 kg; and 4. The subject's primary anesthesia care team has planned for a neuraxial anesthetic (i.e. spinal, epidural or combined-spinal epidural). 5. The patient agrees to receive an adductor canal block. 6. American Society of Anesthesiologists class 1-3 Subject is < 18 years of age or >80 years of age; 2. Subject is non-English speaking; 3. Subject is known or believed to be pregnant; 4. Subject is a prisoner; 5. Subject has impaired decision-making capacity; per discretion of the Investigator 6. Symptomatic untreated gastroesophageal reflux or otherwise at risk for perioperative aspiration; 7. Any condition for which the primary anesthesia care team deems neuraxial anesthesia inappropriate; 8. Significant pre-existing neuropathy on the operative limb; 9. Significant renal, cardiac or hepatic disease per discretion of the investigator. 10. American Society of Anesthesiologists class 4-5 11. Known hypersensitivity and/or allergies to local anesthetics 12. Chronic Opioid Use (daily or almost daily use of opioids for > 3 months) | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 5.0-12.0, Asthma Diagnosis of asthma Currently receiving long-term asthma control therapy and either has symptoms consistent with persistent asthma or has evidence of uncontrolled disease or is not currently receiving long-term asthma control therapy and has symptoms consistent with persistent asthma and also has evidence of uncontrolled disease Caretaker speaks English or Spanish Younger or older children Mild, intermittent asthma | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, de Novo Stenotic Lesions in Native Coronary Arteries General 1. Subject is ≥18 years old. 2. Subject is eligible for percutaneous coronary intervention (PCI). 3. Subject is eligible for dual anti-platelet therapy (DAPT) with aspirin plus either clopidogrel, prasugrel or ticagrelor for a minimum of 1 month. 4. Subject understands the nature of the procedure and provides written informed consent prior to the catheterization procedure. 5. Subject is willing to comply with specified follow-up evaluation and can be contacted by telephone. 6. Subject is an acceptable candidate for coronary artery bypass graft (CABG) surgery. 7. Subject has stable angina pectoris (Canadian Cardiovascular Society Classification [CCSC] 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class 1-3, B-C) or a positive functional ischemia study (e.g. exercise tolerance test [ETT], single-photon emission computerized tomography [SPECT], stress echocardiography or cardiac computerized tomography [CT]). 8. Female subjects of child bearing potential must have a negative pregnancy test within 7 days prior to enrollment in the study. Angiographic 1. Subject is indicated for elective stenting of a single stenotic lesion in a native coronary artery. 2. Reference vessel ≥2.5 mm and ≤4.0 mm in diameter by visual estimate. 3. Target lesion ≤30 mm in length by visual estimate (the intention should be to cover the whole lesion with 1 stent of adequate length). 4. Target lesion stenosis ≥50% and <100% by visual estimate General Subject is currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints. 2. Subject was enrolled in another stent trial within 2 years prior to the index procedure. 3. Any planned elective surgery or percutaneous intervention within 9 months post- procedure. 4. A previous coronary interventional procedure of any kind within 30 days prior to the procedure. 5. The subject requires staged procedure of either the target vessel or any non-target vessel within 9 months post-procedure. 6. The target lesion requires treatment with a device other than percutaneous transluminal coronary angioplasty (PTCA) prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.). 7. Previous drug-eluting stent (DES) deployment anywhere in the target vessel. 8. Any previous DES deployment within the past 12 months. 9. Any previous stent placement within 15 mm proximal or distal to the target lesion. 10. Co-morbid condition(s) that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial. 11. Concurrent medical condition with a life expectancy of <3 years. 12. Documented left ventricular ejection fraction (LVEF) <25% at the most recent evaluation. 13. Evidence of an acute MI within 72 hours of the intended index procedure. 14. History of cerebrovascular accident or transient ischemic attack within 6 months prior to the index procedure. 15. Leukopenia (leukocytes <3.5 x 109/liter). 16. Neutropenia (absolute neutrophil count <1,000/mm3) ≤ within 7 days prior to enrollment. 17. Thrombocytopenia (platelets <100,000/mm3) pre-procedure (within 7 days prior to enrollment). 18. Active peptic ulcer or active gastrointestinal (GI) bleeding. 19. Subjects who are ineligible for ≥1 month of DAPT because of bleeding diathesis or any other reason. 20. Known hypersensitivity or contraindication to aspirin, thienopyridine, both heparin and bivalirudin, cobalt, nickel, L-605 cobalt chromium alloy or sensitivity to contrast media which cannot be adequately pre-medicated. 21. Serum creatinine level >2.5 mg/dL within 7 days prior to the index procedure. 22. Subject was previously enrolled in the Study or the Post-Market Study. Angiographic Unprotected left main coronary artery disease (obstruction >50% in the left main coronary artery that is not protected by ≥1 non-obstructed bypass graft to the left anterior descending [LAD] or left circumflex [LCX] artery or a branch thereof). 2. Target vessel exhibiting multiple lesions with >60% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion based on visual estimate or on-line quantitative coronary angiography (QCA). 3. Target lesion exhibiting an intraluminal thrombus (occupying >50% of the true lumen diameter) at any time prior to the start of the intervention. 4. Lesion location that is aorto-ostial or within 5 mm of the origin of the LAD or LCX. 5. Target lesion with side branches >2.0 mm in diameter. 6. Target lesion involving a bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch). 7. Target lesion with severe calcification. 8. Target vessel exhibiting excessive tortuosity that may impede stent delivery and deployment at target lesion. 9. Target lesion that is located in a native vessel distal to an anastomosis with a saphenous vein graft or a left/right internal mammary artery (LIMA/RIMA) bypass | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Carotid Stenosis Stroke Carotid Artery Plaque Transient Ischemic Attack Cerebrovascular Accident Carotid Artery Stenosis (Patients) Patients undergoing carotid endarterectomy for established clinical Age > 18 years Male or Female English speaking Patients must sign written informed consent form (Controls) A spouse or sibling of a Patient Subject Age > 18 years Male or Female English speaking (Patients) Previous history of carotid artery surgery (endovascular or open) Previous cervical radiation Patients not felt be suitable for carotid endarterectomy Patients with impaired consent capacity Contraindication to MRI scans (impaired renal function, need for sedative medication during scans, inability to lie in scanner for 60 minutes) Prisoner status (Controls) Control-Subjects with impaired consent capacity Prisoner status | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-80.0, Stroke Ischemic stroke or TIA in anterior circulation within 90 days MCA atherosclerotic moderate to severe stenosis(50%-99%) confirmed by conventional angiography or magnetic resonance angiography Age >18 or more atherosclerotic risk factors including hypertension, hypercholesterolemia, diabetes mellitus, cigarette smoking, and obesity Medical treatment Not receiving stent therapy Ability to comply with all studies Multiple intracranial arteries stenosis (> 50%) or occlusion Less than 2 atherosclerotic risk factors Pregnancy and other contraindication to MRI scan Informed consent not obtained | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Diastolic Heart Failure Diastolic Dysfunction Clinical 1. Adult (age > 18 years) 2. Diagnosis of heart failure with preserved ejection fraction 3. NYHA F. Class III or IV or documented history of at least two heart failure hospitalization in the past year prior to enrollment. 4. No contraindication for anticoagulation and antiplatelet treatment. 5. Optimal medical cardiovascular pharmacotherapy with stable doses for at least 4 weeks (not including diuretics) 6. Pulmonary Wedge pressure > 15 mmHg documented by right heart catheterization at enrollment. 7. Patient understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed 8. Patient is able and willing to adhere to the required follow-up visits and testing 9. Minimal endocardial height from Apex to Mitral Annulus > 60mm at end systole Echocardiographic 1. Left ventricular ejection fraction≥50% 2. HFpEF diagnosis according to ESC 2016 guidelines 3. No evidence of intra-cardiac thrombus Cardiovascular disease: 1. Implanted or planned implantation of defibrillator devices such as ICD cardiac resynchronization device (CRT-D) or left ventricular assist device (LVAD). 2. Within the past 3 months Acute myocardial infarction (AMI), cerebral vascular accident (CVA), or Transient Ischemic Attack (TIA). 3. History of thrombus within the previous 3 months. 4. Coronary Artery Bypass Surgery (CABG), valve replacement or repair, aortic surgery or percutaneous coronary intervention (PCI in the past 3 months or planned/anticipated within the coming 6 months. Patients with mechanical valve replacement or CABG performed more than 3 months before may be eligible for enrollment. 5. Significant valvular disease classified as Moderate or severe aortic stenosis/regurgitation Moderate or severe mitral stenosis Severe mitral regurgitation 6. Hypertrophic cardiomyopathy 7. History of pericardial disease. 8. HF attributed to Cor pulmonale or other cause of isolated right heart failure. 9. Moderate to severe right ventricle failure or right ventricular myocardial infarction. 10. Infiltrative heart disease including amyloidosis. Non-cardiovascular disease: 1. Prior surgery, radiation, or thoracic surgery limiting the ability to place the device. 2. Moderate to severe asthma or COPD, or severe restrictive lung disease. 3. Severe chronic renal failure indicated by MDRD GFR <30 mL/min/1.73 m2. 4. Liver impairment addressed by bilirubin > 2 mg/dl and serum albumin <3 g/dL 5. Severe anemia addressed by Hb concentration <9 gr/l. 6. Solid organ or hematologic transplant. 7. Previous Trans Apical procedures/implantation. Miscellaneous conditions: 1. Co-morbid condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements. 2. Pregnancy at the time of enrollment. (Women of childbearing potential must have a negative serum pregnancy test within two weeks prior to enrollment, or be using hormonal contraceptives or intrauterine devices). 3. Participating in another treatment investigational study. 4. A history of alcohol abuse, drug addiction, or other psychosocial condition that would preclude successful participation, or clear judgment and informed consent in the opinion of the Principal Investigator | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Diabetes Heart Disease Male or Female, aged 18 years or older; 2. Diabetes Mellitus (Type 1 or Type 2) undergoing treatment; 3. Multivessel disease involving the LAD + at least one other coronary territory (stenosis ≥ 70% in a 1.5 mm artery) in a patient referred for cCABG; 4. Angiographic lesion characteristics amenable to both PCI/DES and MICS CABG; 5. Indication for revascularization based upon objective ischemia Severe congestive heart failure (class III or IV NYHA) at enrollment; 2. Left ventricular ejection fraction less than 20%; 3. Prior CABG surgery; 4. Prior heart valve surgery; 5. Prior PCI within the previous 6 months; 6. Previous tuberculosis or trauma to the chest that may have caused adhesions or LITA damage; 7. Previous stroke within 6 months or patients with stroke at more than 6 months with significant residual neurologic involvement, as reflected by a Rankin Score > 1; 8. Prior history of significant bleeding that might be expected to recur with MICS CABG or PCI/DES related anticoagulation; 9. STEMI or Q-wave MI within 72 hours prior to enrollment; 10. Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting); 11. Contraindication to either cCABG, MICS CABG, or PCI/DES because of a coexisting clinical condition; 12. Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis; 13. Intolerance or contraindication to aspirin or both clopidogrel and ticagrelor; 14. Dementia with a Mini Mental Status Examination (MMSE) score of < 20; 15. Extra-cardiac illness that is expected to limit survival to less than 5 years; 16. Suspected pregnancy. A pregnancy test (urine or serum) will be administered to all women not clearly menopausal; 17. Concurrent enrollment in another clinical trial; 18. Geographic inaccessibility for the follow-up visits required by protocol | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 40.0-80.0, Stroke Ischemic Attack, Transient Provision of informed consent. 2. Female or male aged≥ 40 years and <80 years. 3. Acute non-disabling ischemic stroke (NIHSS≤ 3 at the time of randomization) that can be treated with study drug within 24 hours of symptoms onset defined by the"last see normal"principle. 4. TIA (Neurological deficit attributed to focal brain ischemia, with resolution of the deficit within 24 hours of symptom onset), that can be treated with study drug within 24 hours of symptoms onset and with moderate-to-high risk of stroke recurrence (ABCD2 score ≥ 4 at the time of randomization or the stenosis of offending vessel ≥ 50%) Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other major non-ischemic brain disease (e.g., multiple sclerosis) on baseline head Computed Tomography (CT) or magnetic resonance imaging (MRI). 2. Isolated or pure sensory symptoms (e.g., numbness), isolated visual changes, or isolated dizziness/vertigo without evidence of acute infarction on baseline head CT or MRI. 3. Modified Rankin Scale Score > 2 at randomization (pre-morbid historical assessment)。 4. Contraindication to ticagrelor, clopidogrel or acetylsalicylic acid Known hypersensitivity Severe renal or hepatic insufficiency Severe cardiac failure, asthma Hemostatic disorder or systemic bleeding History of hemostatic disorder or systemic bleeding History of drug-induced hematologic or hepatic abnormalities Low white blood cell (<2 x10^9/L) or platelet count (<100 x10^9/L) 5. Clear indication for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, ventricular aneurysm, prosthetic cardiac valves known, suspected endocarditis or other suspicion of cardioembolic pathology for TIA/stroke). 6. Continuous use of ticagrelor or clopidogrel over 5 days before randomization 7. Current treatment (last dose given within 10 days before randomization) with heparin therapy or anti coagulation therapy (e.g., warfarin; thrombin inhibitors such as dabigatran , argatroban, bivalirudin, ximelagatran; factor Xa inhibitors such as rivaroxaban, edoxaban, apixaban, betrixaban, tanexaban ; hirudin; unfractionated and low molecular weight heparins ). 8. Receipt of intravenous/ intra-arterial thrombolysis or mechanical thrombectomy within 24 hours prior to randomization. 9. History of intracranial hemorrhage or cerebral artery amyloidosis. 10. History of aneurysm (including intracranial aneurysm or peripheral aneurysms) 11. Diagnosis or of acute coronary syndrome. 12. History of asthma or COPD (chronic obstructive pulmonary disease). 13. High risk of bradyarrhythmia, such as sick sinus syndrome second-degree or third-degree atrioventricular block, bradycardia-related syncope without installed pacemaker. 14. History of uric acid nephropathy. 15. Anticipated requirement for long-term (>7 days) non-study anti-platelet drugs, or NSAIDs (nonsteroidal antiinflammatory drugs) affecting platelet function. 16. History of previous symptomatic non-traumatic intracerebral bleed at any time (asymptomatic microbleeds do not qualify), gastrointestinal (GI) bleed within the past 3 months, or major surgery within 30 days. 17. Qualifying TIA or minor stroke induced by angiography or surgery. 18. Planned or likely revascularization within the next 3 months. 19. Scheduled for surgery or interventional treatment requiring study drug cessation. 20. Severe non-cardiovascular comorbidity with life expectancy < 3 months. 21. Pregnancy or lactation, and women of childbearing age not practicing reliable contraception who do not have a documented negative pregnancy test. 22. Currently receiving an investigational drug or device. 23. Participation in another clinical study with an investigational product during the last 30 days. 24. Inability of the patient to understand and/or comply with study procedures and/or follow-up, in the opinion of the Investigator. 25. Hematocrit (Hct) < 30% | 1 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 65.0-999.0, Heart Failure > 65 years of age 2. male and female patients admitted to the hospital with the primary diagnosis of HF with hospitalization > 24 hours 3. able to read and write in English 4. discharged to home environment a cardiac transplant candidate 2. experienced an acute coronary event within the previous 30 days of index hospitalization 3. experienced percutaneous coronary intervention or coronary artery bypass grafting within the previous 30 days of index hospitalization 4. end stage renal disease/hemodialysis 5. have a left ventricular assist device 6. > 400 lbs 7. unable to stand for 90 seconds independently | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Peripheral Arterial Disease High risk for carotid endarterectomy due to anatomical or co-morbid conditions and either has neurological symptoms and ≥ 50% stenosis via angiography, or is asymptomatic and has ≥ 80% stenosis via angiography. 1. Target lesion located in the distal common carotid artery (CCA), internal carotid artery (ICA), or carotid bifurcation. 2. Arterial segment to be stented has a diameter between 4mm and 9mm 3. Age ≥ 18 years. 4. Life expectancy > 12 months from the date of the index procedure. 5. Provides a signed, IRB (Institutional Review Board) / IEC (Institutional Ethical Committee) approved informed consent form prior to participation. 6. Willing and able to comply with follow-up requirements Contra-indication to percutaneous transluminal angioplasty (PTA). 2. Sever vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system. 3. Lesions in the ostium of the common carotid artery. 4. Occlusion of the target vessel. 5. Evidence of intraluminal thrombus. 6. Known sensitivity to nickel-titanium. 7. Known allergy to heparin, aspirin or other anticoagulant/antiplatelet therapies, or is unable or unwilling to tolerate such therapies. 8. Uncorrectable bleeding disorders, or will refuse block transfusion. 9. History of prior life-threatening contrast media reaction. 10. Previous stent placement in the target vessel. 11. Evolving stroke or intracranial haemorrhage. 12. Previous intracranial haemorrhage or brain surgery within the past 12 months. 13. Clinical condition that makes endovascular therapy impossible or hazardous | 2 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Ischemic Stroke Over 18 years last seen normal between 8 hours, without prior history of intravenous plasminogen activator (IV t-PA ) or mechanical thrombectomy Vessels intracranial vertebral artery, basilar artery, intracranial ICA, ICA terminus bifurcation, MCA M1/M2, or ACA NIHSS ≥ 7 MRI DWI/PWI or CTA/P, which demonstrates an area of mismatch ≥ 2/3 rd Signed informed consent creat >= 2 NIHSS < 7 Baseline mRS >= 2 infarct > 1/3rd MCA territory competing trials prior IV or IA treatment | 0 |
74M hx of CAD s/p CABG, EF 60% prior CVA (no residual deficits), HTN, HL, DMII, Moderate to Severe PVD was referred to cardiology for evaluation of PVD, and on examination patient was found to have carotid bruits. Upon further review of symptoms the pt reports + Occasional dizziness, no prior syncope occasional HA, Denies CP/SOB. No sensory or motor defects. He recalls that he might have had a stroke 10-15 years ago without any residual deficit. Prior to CABG he only had diaphoresis. Further review of systems is notable for absence of chest pain, dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, palpitations, syncope or presyncope. He underwent Carotid U/S that showed significant bilateral carotid stenosis, L>R. Angiography revealed an 80% stenosis of the R ICA and a 90% L ICA stenosis. Cerebral angiography further revealed patent right ACA and MCA and patent left ACA and left MCA. Past Medical History: CAD s/p CABG in [**2154**] ([**Hospital1 112**]) Prior CVA Bilateral carotid artery disease Anemia PVD Hypertension Diabetes c/b retinopathy and peripheral neuropathy Cataracts s/p surgery Thyroid nodule Colon polyps s/p resection Intermittent Lower back pain Proteinuria s/p right elbow fracture as a child Arthritis | eligible ages (years): 18.0-999.0, Carotid Artery Disease Patient must meet one of the following regarding neurological symptom status and degree of stenosis: Symptomatic: Stenosis must be >50% as determined by an angiogram and the patient has a history of stroke (minor or non-disabling; NIHSS ≤4 or mRS ≤2), TIA and/or amaurosis fugax within 180 days of the procedure procedure ipsilateral to the carotid artery to be stented. OR Asymptomatic: Stenosis must be >80% as determined by angiogram without any neurological symptoms within the prior 180 days. 2. Target vessel must meet all requirements for Transcarotid Neuroprotection System and Stent System (refer to IFU for requirements). 3. Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA). 4. Patient is ≥18 years of age. 5. Patient understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Institutional Review Board/Ethics Committee of the respective clinical site prior to the procedure. This will be obtained prior to participation in the study. 6. Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations. 7. Patient must have a life expectancy ≥ 3 years at the time of the index procedure without contingencies related to other medical, surgical or endovascular intervention. 8. Patient meets at least one of the surgical high-risk listed below. Anatomic High Risk A. Contralateral carotid artery occlusion B. Tandem stenoses >70% C. High cervical carotid artery stenosis D. Restenosis after carotid endarterectomy E. Bilateral carotid artery stenosis requiring treatment within 30 days after index treatment. F. Hostile Necks which the Investigator deems safe for transcarotid access including but not limited to: I. Prior neck irradiation II. Radical neck dissection III. Cervical spine immobility Clinical High Risk G. Patient is > 75 years of age H. Patient has > 2-vessel coronary artery disease and history of angina of any severity I. Patient has a history of angina Canadian Cardiovascular Society (CCS) angina class 3 or 4 or unstable angina J. Patient has congestive heart failure (CHF) New York Heart Association (NYHA) Functional Class III or IV K. Patient has known severe left ventricular dysfunction LVEF <30%. L. Patient has had a myocardial infarction > 72 hours and < 6 weeks prior to procedure. M. Patient has severe pulmonary disease (COPD) with either FEV1 <50% predicted or chronic oxygen therapy or resting PO2 of <60 mmHg (room air) N. Patient has permanent contralateral cranial nerve injury O. Patient has chronic renal insufficiency (serum creatinine > 2.5 mg/dL). The following is a list of anatomical considerations that are not suitable for transfemoral CAS with distal protection that are NOT contraindications for enrollment in the 2 Study including but not limited to: I. TypeII, III, or Bovine arch II. Arch atheroma or calcification III. Atheroma of the great vessel origins IV. Tortuous distal ICA V. Tortuous or occluded iliofemoral segments VI. Occluded aortoiliac segments Each potential patient must be screened to ensure that they do not meet any of the following This screening is to be based on known medical history and data available at the time of determination and enrollment. 1. Patient has an alternative source of cerebral embolus, including but not limited to: 1. Patient has chronic atrial fibrillation. 2. Patient has had any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation. 3. Knowledge of cardiac sources of emboli. e.g. left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma). 4. Recently (<60 days) implanted heart valve (either surgically or endovascularly), which is a known source of emboli as confirmed on echocardiogram. 5. Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis (as determined by angiography or CTA/MRA ≤ 6 months prior to index procedure) greater in severity than the lesion to be treated, cerebral aneurysm > 5 mm, AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal angiographic findings. 2. Patient has a history of spontaneous intracranial hemorrhage within the past 12 months, or has had a recent (<7 days) stroke of sufficient size (on CT or MRI) to place him or her at risk of hemorrhagic conversion during the procedure. 3. Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days. 4. Patient with a history of major stroke attributable to either carotid artery (CVA or retinal embolus) with major neurological deficit (NIHSS ≥ 5 OR mRS ≥ 3) likely to confound study endpoints within 1 month of index procedure. 5. Patient has an intracranial tumor. 6. Patient has an evolving stroke. 7. Patient has neurologic illnesses within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke, including but not limited to: moderate to severe dementia, partial or secondarily generalized seizures, complicated or classic migraine, tumor or other space-occupying brain lesions, subdural hematoma, cerebral contusion or other post-traumatic lesions, intracranial infection, demyelinating disease, or intracranial hemorrhage). 8. Patient has had a TIA or amaurosis fugax within 48 hrs prior to the procedure. 9. Patient has an isolated hemisphere. 10. Patient had or will have CABG, endovascular stent procedure, valve intervention or vascular surgery within 30 days before or after the intervention. 11. Myocardial Infarction within 72 hours prior to the intervention. 12. Presence of a previous placed intravascular stent in target vessel or ipsilateral CCA or significant CCA inflow lesion. 13. Occlusion or [Thrombolysis In Myocardial Infarction Trial (TIMI 0)] "string sign" >1cm of the ipsilateral common or internal carotid artery. 14. An intraluminal filling defect (defined as an endoluminal lucency surrounded by contrast, seen in multiple angiographic projections, in the absence of angiographic evidence of calcification) whether or not it is associated with an ulcerated target lesion. 15. Ostium of Common Carotid Artery (CCA) requires revascularization. 16. Patient has an open stoma in the neck. 17. Female patients who are pregnant or may become pregnant. 18. Patient has history of intolerance or allergic reaction to any of the study medications or stent materials (refer to stent IFU), including aspirin (ASA), ticlopidine, clopidogrel, statin or contrast media (that can't be pre medicated). Patients must be able to tolerate statins and a combination of ASA and ticlopidine or ASA and clopidogrel. 19. Patient must have a life expectancy <3 years without contingencies related to other medical, surgical, or interventional procedures as per the Wallaert Score and patients with primary, recurrent or metastatic malignancy who do not have independent assessment of life expectancy performed by the treating oncologist or an appropriate specialist other than the physician performing TCAR | 2 |
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