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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): 25.0-999.0, Low Back Pain Low back pain for more than 6 months Patient older than 25 years old MRI findings comparable with lumbar degenerative/osteoarthritic changes Spinal stenosis with neurological deficits Spinal prolapse with neurological deficits Rheumatoid arthritis, psoriatic arthritis Old lumbar fractures Chronic pain syndromes (e.g. fibromyalgia) Psychosocial status not suitable for participation Pregnancy Breastfeeding Allergic to shellfish | 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, Acute Ischemic Stroke Patients must meet all of the criteria. 1. Diagnosis of acute ischemic stroke with onset less than 4.5 hours prior to the planned start of intravenous alteplase. Acute ischemic stroke is defined as a measurable neurological deficit of sudden onset, presumed secondary to focal cerebral ischemia. Stroke onset will be defined as the time the patient was last known to be without the new clinical deficit. Patients whose deficits have worsened in the last 4.5 hours are not eligible if their first symptoms started more than 4.5 hours before. If the stroke started during sleep, stroke onset will be recorded as the time the patient was last known to be at baseline. 2. Disabling neurological deficit attributable to acute ischemic stroke in the middle cerebral artery territory. 3. NIHSS less than or equal to 18 for left hemisphere strokes, NIHSS less than or equal to 16 for others. 4. Evidence of MCA occlusion (stem or branch) prior to drug administration by TCD, CTA or MRA. 5. Age 18-85 years, inclusive. 6. Able to sign informed consent. For MRI Arm only: 7. Screening MRI diagnostic of focal cerebral ischemia corresponding to the clinical deficits. The MRI evaluation must involve echo planar diffusion weighted imaging, MRA, and MRI perfusion. A normal appearing MRA with an appropriate perfusion deficit is eligible. An apparent stenosis or occlusion on MRA with normal appearing perfusion distally will not be eligible. Poor quality or uninterpretable MRA will not make patient ineligible. Patients who have a normal appearing DWI are eligible. 8. Evidence on PWI MRI or a perfusion defect corresponding to the acute stroke syndrome. The PWI will be assessed by relative mean transit time (MTT) images obtained prior to the start of rt-TPA therapy Patients will be excluded from study participation for any of the following reasons: 1. Current participation in another study with an investigational drug or device within, prior participation in the present study, or planned participation in another therapeutic trial, prior to the final (day 30) assessment in this trial. 2. Absence of acoustic window to insonate the MCA on the involved side. 3. Time interval since stroke onset of less than 3 hours is impossible to determine with high degree of confidence. 4. Symptoms suggestive of subarachnoid hemorrhage, even if CT or MRI scan is negative for hemorrhage. 5. Evidence of acute myocardial infarction defined as having at least two of the following three features: 1) Chest pain suggestive of cardiac ischemia; 2) EKG findings of ST elevation of more greater than 0.2 mV in 2 contiguous leads, new onset left bundle branch block, ST segment depression, or T-wave inversion; 3) Elevated troponin I. 6. Acute Pericarditis. 7. Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test. 8. Neurological deficit that has led to stupor or coma (NIHSS level of consciousness [item I a] score greater than or equal to 2). 9. High clinical suspicion of septic embolus. 10. Minor stroke with non-disabling deficit or rapidly improving neurological symptoms. 11. Baseline NIHSS greater than 18 for left hemisphere stroke or greater than 16 for others. 12. Evidence of acute or chronic ICH by head CT or MRI. 13. CT or MRI evidence of non-vascular cause for the neurological symptoms. 14. Signs of mass effect causing shift of midline structures on CT or MRI. 15. Persistent hypertension with systolic BP greater than 185 mmHg or diastolic BP greater than 110 mmHg (mean of 3 consecutive arm cuff readings over 20-30 minutes), not controlled by antihypertensive therapy or requiring nitroprusside for control. 16. Anticipated need for major surgery within 72 hours after start of study drugs, e.g., carotid endarterectomy, hip fracture repair. 17. Any intracranial surgery, intraspinal surgery, or serious head trauma (any head injury that required hospitalization) within the past 3 months. 18. Stroke within the past 3 months. 19. History of ICH at any time in the past. 20. Major trauma at the time of stroke, e.g., hip fracture. 21. Blood glucose greater than 200 mg/dl. 22. Presence or history of intracranial neoplasm (except small meninigiomas) or arteriovenous malformation. 23. Intracranial aneurysm, unless surgically or endovascularly treated more than 3 months before. 24. Seizure at the onset of stroke. 25. Active internal bleeding. 26. Major hemorrhage (requiring transfusion, surgery or hospitalization) in the past 21 days. 27. Major surgery, serious trauma, lumbar puncture, arterial puncture at a non-compressible site, or biopsy of a parenchymal organ in last 14 days. Major surgical procedures but are not limited to the following: major thoracic or abdominopelvic surgery, neurosurgery, major limb surgery, carotid endarterectomy or other vascular surgery, and organ transplantation. For non-listed procedures, the operating surgeon should be consulted to assess the risk. 28. Presumed or documented history of vasculitis. 29. Known systemic bleeding or platelet disorder, e.g., von Willebrand's disease, hemophilia, ITP, TTP, others. 30. Platelet counts less than 100,000 cells/micro L. 31. Congenital or acquired coagulopathy (e.g., secondary to anticoagulants) causing either of the following: 1. Activated partial thromboplastin time (aPTT) prolongation greater than 2 seconds above the upper limit of normal for local laboratory, except if due to isolated factor XII deficiency. 2. INR greater than or equal to 1.4. Patients receiving warfarin prior to entry are eligible provided INR is less than 1.4 and warfarin can be safely discontinued for at least 48 hours. 32. Life expectancy less than 3 months. 33. Other serious illness, e.g., severe hepatic, cardiac, or renal failure; acute myocardial infarction; or complex disease that may confound treatment assessment. 34. Severe renal failure: Serum creatinine greater than 4.0 mg/dL or dependency on renal dialysis. 35. AST or ALT greater than 3 times the upper limit of normal for the local laboratory. 36. Treatment of the qualifying stroke with any thrombolytic, anti-thrombotic or GPIIbIIIa inhibitor outside of this protocol. 37. Any administration of a thrombolytic drug in the prior 7 days. 38. Treatment of the qualifying stroke with intravenous heparin unless aPTT prolongation is no greater than 2 seconds above the upper limit of normal for local laboratory prior to study drug initiation. 39. Treatment of the qualifying stroke with a low molecular weight heparin or heparinoid. 40. Known hypersensitivity to TPA. 41. Anticoagulation (evidenced by abnormal INR, aPTT, or platelet count) caused by herbal therapy. FOR non-MRI arm only (#42-43): 42. Ischemic changes on screening CT of greater than approximately one third of the territory of the middle cerebral artery territory by qualitative assessment. 43. Patients who were excluded by screening MRI, except for exclusions #45 (contraindication to MRI) and #46 (PWI was not obtained or is uninterpretable) and #50 (MRI not obtainable because it would have put the patient out of the 3 hour time window for alteplase). FOR MRI arm only (#44-51): 44. Contraindication to MRI scan. 45. PWI not obtained or uninterpretable. 46. No MTT defect corresponding to acute stroke deficit. 47. DWI abnormality larger than approximately one third of the territory of the middle cerebral artery territory by qualitative assessment. 48. Satellite DWI hyperintensity with corresponding hyperintensity on T2 weighted image or FLAIR in a vascular territory different than the index stroke (this is evidence of a new ischemic lesion greater than 3 hours in duration). 49. Evidence of multiple microbleeds on gradient echo MRI (GRE). 50. MRI not obtained because it would have put the patient out of the 3 hour time window for alteplase | 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, Carotid Artery Stenosis The patient has a symptomatic or asymptomatic carotid artery stenosis that meets one of the following Symptomatic: > than or = to 50% carotid stenosis by angiography and a history of non-disabling stroke, transient ischemic attack (TIA) in the hemisphere supplied by the target vessel within 180 days of the procedure Asymptomatic: > than or = to 80% carotid stenosis by angiography without neurological symptoms High risk for carotid endarterectomy: anatomical and co-morbid History of symptoms of stroke or TIA within 24 hours of the procedure Extensive or diffuse atherosclerotic disease Severe vascular tortuosity or anatomy that would preclude the safe introduction of the device | 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): 18.0-60.0, Varicose Veins Males and females aged 18 to 60 with severe varicose veins, CEAP classes 3, 4 and 5 (CEAP is a classification and grading system for chronic venous disease) Saphenofemoral junction (SFJ) incompetence. Retrograde blood flow in the GSV, greater than or equal to 1.0 second demonstrated by duplex scanning Normal MRI, as assessed on MRI examination performed within 5 days prior to procedure Patient must be willing and able to participate in the study and provide written informed consent Presence of venous ulcers (i.e. CEAP classification C6) or local infection in the limb to be treated Incompetence of the small saphenous vein (SSV) in the leg to be treated. Venographic or ultrasonographic evidence of current or previous deep vein thrombosis (DVT) (see Appendix IV) Deep venous occlusion and/or incompetence. Evidence of deep venous reflux is acceptable if it is confined to a limited segment caused by filling of the incompetent superficial system through a perforator or the SFJ Patients with known atherosclerotic disease or presence of major risk factors, including LDL cholesterol greater than 130 mg/dl, blood pressure greater than 140 mmHg systolic or 90 mmHg diastolic, or diabetes requiring treatment with oral hypoglycemic drugs or insulin Smokers History suggestive of cerebral atherosclerosis, transient ischemic attack (TIA), stroke, presence of carotid bruit or history of abnormal carotid duplex examination Clinically significant dilated cardiomyopathy, evidence of regional wall motion abnormalities suggestive of prior myocardial infarction, rheumatic mitral valve disease, moderately severe or worsening cardiac valvular disease (> 2+ on a scale of 4), known or suspected congenital heart disease, evidence of right sided volume or pressure overload, history of atrial fibrillation. Patients with PFO, atrial septal defect, or other right-to-left shunt are not excluded unless associated with other abnormalities as above Peripheral vascular disease Spontaneous emboli seen on TCD prior to contrast injection Body Mass Index >30.0 | 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 Arteriosclerosis Coronary Artery Bypass Graft Myocardial Revascularization Veteran Age 18 or older Ability to give informed consent Have documented CAD and depressed LV function (EF <40%) that is felt to be appropriately treated with surgical revascularization by the VA Salt Lake City Health Care System Cardiothoracic Surgery team and in accordance with the published 2004 ACC/AHA Guideline Update for Coronary Artery Bypass Graft Surgery; specifically, in accordance with the described indication for CABG in patients with Poor LV Function (see below). Class I 1. CABG should be performed in patients with poor LV function who have significant left main coronary artery stenosis. (Level of Evidence: B) 2. CABG should be performed in patients with poor LV function who have left main equivalent: significant (greater than or equal to 70%) stenosis of the proximal LAD and proximal left circumflex artery. (Level of Evidence: B) 3. CABG should be performed in patients with poor LV function who have proximal LAD stenosis with 2 or 3-vessel disease. (Level of Evidence: B) Class IIa CABG may be performed in patients with poor LV function with significant viable noncontracting, revascularizable myocardium and without any of the above anatomic patterns. (Level of Evidence: B) NHYA/CCA Class I or higher Abnormal cardiac wall segment on preoperative data Acutely stable myocardium without evidence of cardiogenic shock or evolving myocardial infarction EF 40% CAD not amenable to CABG ACC/AHA Poor LV Function Class III CABG should not be performed in patients with poor LV function without evidence of intermittent ischemia and without evidence of significant revascularizable viable myocardium. (Level of Evidence: B) Evidence of intermittent ischemia is defined clinically by Cardiovascular Disease Classification (see chart above). Objectively, this can be demonstrated by various modalities that can demonstrate ischemic myocardium. Such modalities SCA, Echo, CMRI, and radionucleotide imaging Patients undergoing cardiac re-operation Patients with operable valvular disease Patients with preexisting malignant arrhythmia Patients with preexisting systemic malignancy Patients with a contraindication to MRI Presence of ongoing local or systemic infection | 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): 30.0-69.0, Diabetes Mellitus Results of 75-g oral glucose tolerance test (75 g OGTT)will be used to confirm FPG <= 125 mg/dL, 2-h PG >= 200 mg/dL and HbA1c <= 6.9% Type 1 diabetes mellitus Undergoing treatment with steroids Secondary diabetes mellitus Diabetes mellitus due to suspected gene abnormalities BMI >= 35 kg/m2 or BMI < 18.5 kg/m2 Undergone a surgery Severe hyperuricemia (gout) associated with organ dysfunction Severe vascular diseases with organ dysfunction Cancer or other malignant neoplasms Liver cirrhosis or chronic hepatic, chronic renal failure | 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 Left Ventricular Dysfunction Sudden Cardiac Death Randomized Arm 1. Evidence of Coronary Artery Disease (CAD)a. 2. Evidence of prior Myocardial Infarction defined by either: A. Clinical history of prior myocardial infarction OR B. Mild-moderate systolic LV dysfunction with an EF ≤50% 3. LVEF>35% by any current standard evaluation technique (e.g., echocardiogram, MUGA, angiography). • Patients who have an EF between 30-35% and NYHA Class I heart failure who do not have a history of ventricular tachyarrhythmias, or inducible ventricular tachycardia during electrophysiological (EP) testing can be enrolled (Target Population). 4. CE-MRI measure of infarct mass > 10% of LV mass (as measured by the MRI core lab) • If CE-MRI performed ≤ 40 days after myocardial infarction infarct mass must be ≥ 15% of the LV mass. 5. Patients aged 18 years or above 1. CAD will be confirmed by evidence of one of the following three (3) 1) Prior myocardial infarction, 2) Significant stenosis of a major epicardial vessel (>50% proximal or 70% distal) by coronary angiography, 3) Prior revascularization (percutaneous coronary intervention or coronary artery bypass surgery. Patients may not be randomized until 90 days after revascularization. 2. MI should be documented by the presence of two (2) of the following three (3) 1) Symptoms consistent with myocardial infarction (i.e. chest pain, shortness of breath), 2) Q-waves on electrocardiogram and 3) Elevated cardiac enzymes (CPK elevation > two times or troponin elevation > three times the upper limit of normal for the lab). Patients may not be randomized until 40 days after myocardial infarction History of cardiac arrest or spontaneous or inducible sustained VT (15 beats or more at a rate of 120 BPM or greater)* 2. Unexplained syncope 3. Need for revascularization based on investigator's clinical assessment within the next 12 months (patients may be reevaluated 90 days after revascularization) 4. Currently implanted permanent pacemaker and/or pacemaker/ICD lead 5. Contraindication to a ICD implant (i.e. inadequate venous access, bleeding disorder) 6. Acute or chronic severe renal insufficiency (< 30mL/min/1.73m2); acute renal insufficiency of any severity due to hepato-renal syndrome 7. Current or planned renal or liver transplant 8. End stage renal disease on hemodialysis or peritoneal dialysis 9. Contraindication to CE-MRI or history of allergy to gadolinium-based contrast dye 10. Metal fragments in the eyes or face, implantation of any electronic devices such as (but not limited to) cardiac pacemakers, cardiac defibrillators, cochlear implants or nerve stimulators, surgery on the blood vessels of the brain, body piercing 11. Recent MI (<40 days) or revascularization (<90 days) 12. CVA within 90 days 13. Antiarrhythmic drug therapy for ventricular arrhythmias 14. New York Heart Association CHF functional class IV at enrollment Non-Investigational Registry Evidence of CAD a with either a history of prior myocardial infarction OR any LV dysfunction Evidence of LV dysfunction (ejection fraction) as measured by any current standard screening technique (e.g., echocardiogram, MUGA, angiography).c Clinical CE-MRI within the past 12 months (scheduled or completed) Patients aged 18 years or above CAD will be confirmed by evidence of one of the following three (3) 1) Prior myocardial infarction, 2) Significant stenosis of a major epicardial vessel (>50% proximal or 70% distal) by coronary angiography, 3) Prior revascularization (percutaneous coronary intervention or coronary artery bypass surgery MI should be documented by the presence of two (2) of the following three (3) 1) Symptoms consistent with myocardial infarction (i.e. chest pain, shortness of breath), 2) Q-waves on electrocardiogram and 3) Elevated cardiac enzymes (CPK elevation > two times or troponin elevation > three times the upper limit of normal for the lab) Patients can be enrolled in the registry even if they have received or are about to receive an ICD for primary prevention History of cardiac arrest or spontaneous or inducible sustained VT (15 beats or more at a rate of 120BPM or greater)* Contraindication to CE-MRI or history of allergy to gadolinium-based contrast | 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, Asymptomatic Artery Atherosclerosis is the underlying disease Patients with an asymptomatic stenosis >80% (NASCET) with a documented progression of the degree of stenosis to >80% within 6 months with a very tight stenosis ≥90% at initial presentation with a >80% stenosis plus silent ipsilateral ischemia documented by CCT or MRI with ipsilateral >80% stenosis plus contralateral >80% stenosis or occlusion with >80% stenosis plus planned major surgery Neurologist´s explicit consent to potentially perform CAS Inability to provide informed consent Underlying disease other than atherosclerosis (inflammatory or autoimmune disease) Traumatic or spontaneous carotid dissections Life expectancy <6 months Advanced dementia Advanced renal failure (serum creatinine >2.5 mg/dL) Unstable severe cardiovascular comorbidities (e.g. unstable angina, heart failure) Restenosis after prior CAS or CEA Allergy or contraindications to study medications (clopidogrel, statins, ASA) | 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, Disease Management Diabetes Complications Diabetic Vascular Complications Diabetic Neuropathy Diabetic Nephropathy Diabetic Retinopathy Ambulatory patients over the age of 18 years with diabetes mellitus. 2. Current enrolment in ADEC program (>6 months)or new enrolment in ADEC program (<6 months). 3. Confirmed diagnosis of diabetes mellitus, according to the current Canadian Diabetes Guidelines. 4. Informed consent provided History of only gestational diabetes. 2. Non-GHC member. 3. GHC patients with diabetes who do not attend the ADEC program. 4. Unable to give informed consent. 5. Any conditions/circumstances that prevent the patient from attending ADEC sessions or participating fully in the program. 6. Refusal to allow research staff access to medical records, including hospital charts | 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, Coronary Artery Disease Obstructive Sleep Apnea Patients with angiographically-verified CAD who have newly undergone PCI or CABG treatment Written, informed study consent OSA (AHI>=15 per hour) or non-OSA (AHI<5 per hour) diagnosis on the unattended sleep recording at home Patients with already treated OSAS Patients presenting mainly central apneas (Cheynes-Stokes breathing) Patients with borderline OSA (AHI <15 and >=5 per hour) upon the unattended sleep recording at home | 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 Heart Disease Congestive Heart Failure Ventricular Dysfunction Low Cardiac Output Sudden Cardiac Death documented chronic coronary heart disease (prior MI and/or angiographically documented CAD), > 40 days post the most recent MI LVEF < 40% (by MUGA) and NYHA functional class II or III at time of assessment OR LVEF ≤ 35 % (by MUGA) and NYHA functional class I, II or III at time of assessment Judged to have a reasonable expectation of survival with a good functional status for more than 1 year, as well as receiving optimum, guideline recommended therapy for coronary artery disease and heart failure (or demonstrated intolerance or contraindications to such therapy) Age ≥ 18 years; no upper age limitation Prior cardiac arrest, sustained VT or VF, or unexplained syncope Attempted VT / VF induction at electrophysiological study Need for a cardiac resynchronization therapy (CRT) device Enrollment in another interventional trial | 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, Hyperlipidemias Atherosclerosis Coronary Heart Disease Carotid Stenosis Peripheral Vascular Diseases Diabetes Mellitus Secondary prevention patients with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PVD, etc.) and/or diabetes who already receive cholesterol-lowering therapy Patients who do not receive cholesterol-lowering therapy | 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): 18.0-70.0, Hyperlipidemias Atherosclerosis Coronary Heart Disease Carotid Stenosis Peripheral Vascular Diseases Diabetes Mellitus Secondary prevention patients with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PVD, etc.) and/or diabetes who already receive cholesterol-lowering therapy Patients who do not receive cholesterol-lowering therapy | 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): 9.0-999.0, Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Delivery Systems Type 1 or type 2 diabetes mellitus for at least 12 months Adults at least 18 years Children/adolescents between 9-18 years HbA1c lesser than or equal to 11.0% Known or suspected alcohol or drug abuse Patients who are not able to read the user manual (may wear glasses if needed) Hypoglycaemic unawareness as judged by the investigator Visual and/or dexterity impairments as judged by the 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): 0.0-999.0, Sciatica Persons with lower back pain None | 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, Ischemic Stroke Transient ischemic attack (TIA) or non-severe stroke within 30 days of enrollment attributed to 70-99% stenosis of a major intracranial artery (carotid artery, MCA stem (M1), vertebral artery, or basilar artery) • may be diagnosed byTranscranial Doppler (TCD), Magnetic Resonance Angiogram (MRA), or computed tomography angiography (CTA) to qualify for angiogram performed as part of the study protocol but must be confirmed by catheter angiography for enrollment in the trial 2. Modified Rankin score of ≤ 3 3. Target area of stenosis in an intracranial artery that has a normal diameter of 2.00 mm to 4.50 mm 4. Target area of stenosis is less than or equal to 14 mm in length 5. Age ≥ 30 years and ≤ 80 years. • Patients 30-49 years are required to meet at least one additional (i-vi) provided in the table below to qualify for the study. This additional requirement is to increase the likelihood that the symptomatic intracranial stenosis in patients 30-49 years is atherosclerotic. i. insulin dependent diabetes for at least 15 years ii. at least 2 of the following atherosclerotic risk factors: hypertension (BP > 140/90 or on antihypertensive therapy); dyslipidemia (LDL > 130 mg /dl or HDL < 40 mg/dl or fasting triglycerides > 150 mg/dl or on lipid lowering therapy); smoking; non-insulin dependent diabetes or insulin dependent diabetes of less than 15 years duration; family history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, peripheral vascular surgery in parent or sibling who was < 55 years of age for men or < 65 for women at the time of the event ii. history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease iv. any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery, coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery that was documented by non-invasive vascular imaging or catheter angiography and is considered atherosclerotic v. aortic arch atheroma documented by non-invasive vascular imaging or catheter angiography vi. any aortic aneurysm documented by non-invasive vascular imaging or catheter angiography that is considered atherosclerotic 6. Negative pregnancy test in a female who has had any menses in the last 18 months 7. Patient is willing and able to return for all follow-up visits required by the protocol 8. Patient is available by phone 9. Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion (NOTE: an exception is allowed if the occlusion involves a single vertebral artery proximal to a symptomatic basilar artery stenosis and the contralateral vertebral artery is supplying the basilar artery) 2. Bilateral intracranial vertebral artery stenosis of 70%-99% and uncertainty about which artery is symptomatic (e.g. if patient has pontine, midbrain, or temporal - occipital symptoms) 3. Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to expected enrollment date 4. Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, or plan to perform staged angioplasty followed by stenting of target lesion 5. Plan to perform concomitant angioplasty or stenting of an extracranial vessel tandem to an intracranial stenosis 6. Presence of intraluminal thrombus proximal to or at the target lesion 7. Any aneurysm proximal to or distal to stenotic intracranial artery 8. Intracranial tumor (except meningioma) or any intracranial vascular malformation 9. CT or angiographic evidence of severe calcification at target lesion 10. Thrombolytic therapy within 24 hours prior to enrollment 11. Progressive neurological signs within 24 hours prior to enrollment 12. Brain infarct within previous 30 days of enrollment that is of sufficient size (> 5 cms) to be at risk of hemorrhagic conversion during or after stenting 13. Any hemorrhagic infarct within 14 days prior to enrollment 14. Any hemorrhagic infarct within 15 days that is associated with mass effect 15. Any history of a primary intracerebral (parenchymal) hemorrhage (ICH) 16. Any other intracranial hemorrhage (subarachnoid, subdural, epidural) within 30 days 17. Any untreated chronic subdural hematoma of greater than 5 mm in thickness 18. Intracranial arterial stenosis due to arterial dissection, Moya Moya disease; any known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with Cerebrospinal fluid (CSF) pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; post-partum angiopathy; suspected vasospastic process, suspected recanalized embolus 19. Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction less than 30% 20. Known allergy or contraindication to aspirin, clopidogrel, heparin, nitinol, local or general anesthesia 21. History of life-threatening allergy to contrast dye. If not life threatening and can be effectively pretreated, patient can be enrolled at physician's discretion 22. Active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets < 100,000, hematocrit < 30, International normalized ratio (INR) > 1.5, clotting factor abnormality that increases the risk of bleeding, current alcohol or substance abuse, uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic pressure > 115 mm Hg), severe liver impairment Aspartate Transaminase (AST) or Alanine transaminase (ALT) > 3 x normal, cirrhosis, creatinine > 3.0 (unless on dialysis) 23. Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 90 days after enrollment 24. Indication for warfarin or heparin beyond enrollment (NOTE: exceptions allowed for use of systemic heparin during stenting procedure or subcutaneous heparin for deep vein thrombosis (DVT) prophylaxis while hospitalized) 25. Severe neurological deficit that renders the patient incapable of living independently 26. Dementia or psychiatric problem that prevents the patient from following an outpatient program reliably 27. Co-morbid conditions that may limit survival to less than 3 years 28. Pregnancy or of childbearing potential and unwilling to use contraception for the duration of this study 29. Enrollment in another study that would conflict with the current 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, Heart Failure All patients will have either a sinus or paced atrial rhythm with atrioventricular synchrony on electrocardiography All patients will have a history of heart failure diagnosed clinically with history of prior symptoms or signs of heart failure with at least one of the following symptoms within the past month: dyspnea on exertion, orthopnea, paroxysmal nocturnal dyspnea, pedal edema In asymptomatic patients, patients may be enrolled if they have at least one of the following clinical signs of heart failure: left ventricular third and/or fourth heart sound, jugular venous pressure >7 mmHg, sustained left ventricular impulse, or pulmonary congestion on auscultation all patients will have echocardiographic evidence of left ventricular dysfunction Under age 18 | 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, Wounds Hospitalized adults requiring negative pressure dressings Comatose Mentally obtunded Documented chronic psychiatric illness or any documented dementia significant enough to notably impair cognitive function Presence of Manufacturer's contraindications Malignancy in wound Untreated osteomyelitis Unexplored fistula Necrotic tissue Exposed blood vessels or organs Untreated malnutrition | 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 Stenosis Carotid stenosis requiring revascularization and indicating either symptomatic status, with carotid stenosis ≥ 50% OR asymptomatic status with carotid stenosis ≥ 80% Target lesion is located in one of the following:(a) internal carotid artery (ICA) (b) bifurcation (c) common carotid artery (CCA) proximal to the bifurcation At Anatomic risk for adverse events from CEA (e.g. restenosis after a prior CEA) OR at Co-morbid risk for adverse events from CEA (e.g., unstable angina with ECG changes) Recent surgical procedure within 30 days before or after the stent procedure Uncontrolled sensitivity to contrast media Renal Insufficiency Recent evolving, acute stroke within 21 days of study evaluation Myocardial infarction within 72 hours prior to stent procedure History of a prior major ipsilateral stroke with residual neurological deficits likely to confound the neurological assessments (e.g., NIHSS) Neurological deficits not due to stroke likely to confound the neurological assessments (e.g., NIHSS) Angiographic Isolated ipsilateral hemisphere leading to subject intolerance to reverse flow Total occlusion of the ipsilateral carotid artery Pre-existing stent in the ipsilateral carotid artery OR the contralateral carotid artery that extends into the aortic arch | 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 years and above informed consent for female subjects, not pregnant or planning on becoming pregnant meet protocol defined anatomical or clinical high risk participation in another clincial study which may affect either the pre-procedure or follow-up results prior stenting of the ipsilateral carotid artery life expectancy less than twelve months known allergy or intolerance of study medications or device materials must not meet general or angiographic as defined in the 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): 19.0-999.0, Ischemic Stroke Criteria:Subjects will be eligible if the following are met Ability to provide written informed consent and comply with study assessments for the full duration of the study Age > 18 years NIHSS ≥ 4 or isolated aphasia or isolated hemianopsia NIHSS >30 Coma Rapidly improving symptoms History of stroke in the last 6 weeks Seizure at onset Subarachnoid Hemorrhage (SAH ) or suspected SAH Any history of Intracrannial Hemorrhage (ICH) Neoplasm Septic embolism Surgery, biopsy, trauma or LP in last 30 days | 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, Mortality Hyperhomocysteinemia Inflammation Hemodialysis patients with age > 18 years on regular bicarbonate hemodialysis or hemodiafiltration treatment three times a week Clinical stability at least three months before the study started Cardiovascular disease assessment as presence/absence of hypertension, ischemic cardiac disease, cerebral and peripheral vascular disease, diabetes We will investigate coronary artery disease by determination of at least one of the following parameters previous documentation of acute myocardial infarction (laboratory or ECG modifications) symptomatic CVD events in the clinical history confirmed by a positive treadmill test coronary artery stenosis more than 50% in one of the three major coronary vessels documented by an angiographic study. All patients with coronary artery disease will be examined by a treadmill test (thallium scan) or coronary angiographic exam before entering the study We will investigate cerebrovascular disease by one of the following a previous ictus (ongoing clinical evidence of neurological deficit in the three months before the study beginning, confirmed by a TC scan, a nuclear magnetic resonance or a physician's record of clinical history) carotid vessels stenosis more than 50% documented by a Doppler exam Diagnosis of one of the following clinical conditions in the last three months acute infection vascular access thrombosis ictus cerebri myocardial infarction hemorrhage recent relevant surgery Malignancy Participation in other clinical trials | 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): 50.0-80.0, Atherosclerosis for Main Study: 1. Adult male and female subjects, between 50 and 80 years of age, inclusive, with a body weight > 50 kg and body mass index (BMI) between 19 and 35 kg/m2 2. Subjects who have experienced a CV event (acute coronary syndrome, unstable angina, CABG, PCI, stroke, MI, TIA, carotid endarterectomy), but have been clinically stable for at least 6 months since that event or, have peripheral vascular disease (PVD), as indicated by symptoms of claudication and either a positive imaging/treadmill test, or reduced ankle branchial pressure index or, have a diagnosis of CAD corroborated by stress testing (exercise or pharmacological) or any other confirmed diagnosis of atherosclerotic arterial disease Individuals who have experienced a CV event or have PVD will be given preference for enrolment in the study, if they also have one of the following metabolic syndrome, as defined by NCEP ATP III Framingham score > 20 Current smokers (at least 1pack/day) for Main Study: 1. Any medical history or clinically relevant abnormality identified on the screening medical examination, vital sign measurement, 12-lead ECG recording and/or clinical laboratory examination that is deemed by the principal investigator and/or medical monitor to make the subject ineligible for because of a safety concern. 2. History of heart failure defined as NYHA class II IV or those with known severe LV systolic dysfunction (EF<30%) regardless of symptomatic status 3. Subjects with atrial fibrillation (AF) at screening will be excluded. 4. Insulin controlled Type 1 or Type 2 diabetics 5. Diabetics with fasting glucose > 126mg/dL (7mmol/L) or HbAc1 levels > 8%, at screening. [note: fasting glucose to be checked again at first FDG-PET scan, and if glucose > 11mmol/L at that visit, subject will be excluded from study] 6. Positive pre-study hepatitis B surface antigen or positive hepatitis C antibody results within 3 months of screening. 7. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). 8. Renal impairment with creatinine clearance of <40 ml/min at screening, or history of kidney transplant or history of contrast nephropathy. 9. Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with active chronic inflammation (e.g. Inflammatory Bowel Disease). 10. Subjects with chronic infections such as HIV, gingivitis, periodonitis, prostatitis, gastritis, and urinary tract infections, or any active diseases, including active tuberculosis or a history of active tuberculosis. 11. Subjects with any acute infection, symptoms suggestive of sinusitis, or significant trauma (burns, fractures) 12. History of malignancy within the past 5 years, other than non-melanoma skin cancer. 13. History of skeletal muscle myopathy or rhabdomyolysis 14. Previous exposure to GW856553. 15. Current use of steroids (inhaled or oral) 16. Subjects who have donated more than 500 mL of blood within 56 days prior to the study medication administration. 17. Participation in a clinical study where the subject has received a drug or new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of the drug (whichever is longer) prior to the first dose of study medication 18. History of alcohol/drug abuse or dependence within 12 months of the study 19. The subject has a three month prior history of regular alcohol consumption exceeding an average weekly intake of >28 units (or an average daily intake of greater than 3 units) for males, or an average weekly intake of > 21 units (or an average daily intake of greater than 2 units) for females. 1 unit is equivalent to a half-pint (284mL) of beer/lager; 25mL measure of spirits or 125mL of wine; or a positive alcohol breath test at the screening visit 20. A positive urine test for drugs of abuse (not related to known medications the subject is taking, e.g. codeine for pain management) or alcohol at screening or prior to study medication administration. 21. QTc interval > 450 msec (using average value of triplicate ECGs) 22. Subjects will be excluded if they have participated in clinical research studies involving radiation in the past three years 23. Women must be of non-childbearing potential [i.e. either postmenopausal or documented hysterectomy tubal ligation is not sufficient]. For the purposes of this study, post menopausal is defined as being amenorrhoeic for greater than 2 years with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms. Postmenopausal status will be confirmed by serum or urine FSH and oestradiol concentrations at screening, if appropriate. Surgical sterility will be defined as females who have had a hysterectomy and/or bilateral oophorectomy. 24. An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women; or an unwillingness of the subject to use a condom/spermicide in addition to having their female partner use another form of contraception such as an IUD, diaphragm with spermicide, injectable progesterone, sub-dermal implants or a tubal ligation if the women could become pregnant from the time of the first dose of the study medication until 3 months after administration of last dose of study medication. for Subjects in MRI Sub-study 1. Recent (in approximately last 12 months) echocardiogram with ejection fraction between 30 and 50% for Subjects in MRI Sub-study 1. Contraindication to MRI scanning (as assessed by local MRI safety questionnaire) which includes but not limited to Intracranial aneurysm clips (except Sugita) or other metallic objects History of intra orbital metal fragments that have not been removed by an MD Pacemakers, implantable cardiac defibrillators and non-MR compatible heart valves Inner ear implants History of claustrophobia in MR. 2. Allergy to MRI contrast enhancement agent (gadolinium). 3. Serum creatinine clearance < 60 mL/min (At the discretion of the physician, the subject may progress to a formal assessment based on 24 hour urine collection should serum creatinine limits fall below limits | 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): 35.0-60.0, Hypertension Aged 35-60 No antihypertensive treatment in the past or present SBP< 145 or 85<DBP<95 Informed consent signed Unwilling to participate in the study Treated essential secondary or complicated hypertension SBP lower than 135 or higher than 145 mmHg DBP lower than 85 or higher than 95 mmHg Use of other medications (statins, NSAI ect..) Known allergy to tomato, carotenoids, or vitamin E Diabetes Mellitus Obesity BMI>32 Significant dyslipidemia | 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, Cervical Artery Dissection Stroke Brain Infarction GROUP1 Typical radiological aspect of dissection* in a cervical artery (carotid and/or vertebral);* Mural hematoma, pseudoaneurysm, long tapering stenosis, intimal flap, double lumen, or occlusion > 2 cm above the carotid bifurcation revealing a pseudo aneurysm or a long tapering stenosis after recanalisation Written informed consent Purely intracranial dissection Dissection occurring after an endovascular procedure Known mendelian genetic disorder that can explain the dissection (e.g. vascular Ehlers-Danlos syndrome) GROUP2 Recent ischemic stroke No signs of CAD on extracranial duplex sonography and angiography (digital subtraction or magnetic resonance or CT), performed < 7 days after the stroke Written informed consent Possible cerebral ischemia but normal cerebral imaging CAD cannot be ruled out (e.g.persistent arterial occlusion without mural hematoma) Endovascular or surgical procedure on the coronary, cervical or cerebral arteries during the 48 hours preceding the cerebral infarction Cardiopathies with a very high embolic risk (Mechanical prosthetic valves, mitral stenosis with atrial fibrillation, intracardiac tumor, infectious endocarditis, myocardial infarction<4 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, Carotid Stenosis Subjects with >= 70% carotid stenosis (unilateral or bilateral) who are scheduled to undergo elective carotid endarterectomy Age >= 18 years Agreement of the operating surgeon for patient to participate Surgery scheduled < 14 days after randomization Pregnancy ALT, GGT > 3x upper limit of normal (ULN) Creatinine > 3.5 mg/dL Prior intolerance to statins Reluctance to add or change dosage of statin therapy during 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, Cardiovascular Disease Endothelial Dysfunction CAD or PAD (>50% luminal stenosis), previous myocardial infarction or bypass surgery >3 month ago history of percutaneous coronary intervention (PTCA or stenting) confirmed consent myocardial infarction or acute coronary syndrome or bypass surgery <3 month ago ongoing treatment with statins ongoing vitamin supplementation with folic acid and B vitamins <18 years active smokers uncontrolled arterial hypertension renal insufficiency atrial fibrillation liver disease NYHA class >2 | 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): 25.0-999.0, Peripheral Vascular Diseases Cardiovascular Diseases Have PAD Potential participants with a resting ABI greater than or equal to 0.91 and less than or equal to 1.00 at their baseline visit will be eligible if their ABI drops by at least 20% after the heel-rise test. Potential participants with a resting baseline ABI greater than 0.91 who do not meet for based on the heel-rise test can be eligible if they have data from a certified non-invasive vascular laboratory that demonstrates presence of lower extremity ischemia. However, more evidence than an abnormal PVR from the non-invasive vascular laboratory is required (for example, a toe brachial index pressure less than 0.60). Finally, potential participants who do not meet the above for will be eligible if they have an angiogram demonstrating greater than 50% stenosis on one or more lower extremity arterial vessels Below or above knee amputation Wheelchair confinement Uses a walking aid other than a cane (e.g., walker) Unable to return to the medical center at the required visit frequency Greater than Class II New York Heart Association heart failure or angina (symptoms at rest or with minimal exertion) Any increase in angina pectoris symptoms during the 6 months before study entry or angina at rest Presence of a foot ulcer Lower extremity revascularization or major orthopedic surgery during the 3 months before study entry Heart attack or coronary artery bypass grafting during the 3 months before study entry Major medical illnesses, including treatment for cancer (except non-melanoma skin cancer) during the 12 months before study entry | 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, Prostatitis Chronic Prostatitis With Chronic Pelvic Pain Syndrome Must be male aged ≥ 18 years at time of consent Must understand and voluntarily sign an informed consent form Male subjects with at least 3 months of symptoms of CP/CPPS (pain in the pelvic area, penis, scrotum, or perineum) who are refractory to other therapies (e.g Must be able to adhere to the study visit schedule and other protocol requirements Diagnosis of Chronic Prostatitis with a Chronic Prostatitis Symptom Index of at least 15/24 Must meet the following laboratory Hemoglobin > 9 g/dL Hematocrit ≥ 27% White blood cell (WBC) count ≥ 3000 /mL (≥ 3.0 X 109/L) and < 20,000/mL (< 20 X 109/L) Platelets ≥ 100,000 /mL (≥ 100 X 109/L) Subjects who are female Subjects with a documented positive urine culture within the past three months Subjects with duration of symptoms less than three months Subjects with genital infections within the past three months Subjects with clinical epididymitis within the past three months Subjects with known active or prior genitourinary cancers including renal, ureteral, bladder or prostate Subjects having received prior radiation to the abdominal or pelvic area Subjects with known bladder or ureteral calculi Subjects unable to complete a voiding diary Subjects with neutropenia (ANC < 750/ mm3) | 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): 18.0-80.0, Painful Diabetic Neuropathy Type 1 or 2 Diabetes Diagnosed with peripheral neuropathy Symptoms of: pain and/or numbness Bilateral symptoms (pain in both legs) Have been treated non-surgically Aged 18-80 All genders and all races Cardiac or renal pedal edema Medical condition which does not allow surgery Inadequate glycemic control Skin ulcer Charcot's foot Symptoms of radiculopathy/sciatic-type nerve pain Inadequate nutrient circulation in the feet Weight greater than 300 lbs Psychiatric problems or alcohol/drug abuse 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): 21.0-999.0, Diastolic Heart Failure Be at least 21 years of age Have bilateral carotid bifurcations that are below the level of the mandible Have a left ventricular ejection fraction ≥ 45% Clinical Heart Failure with elevated BNP or NT-Pro-BNP History of or suspected baroreflex failure or autonomic neuropathy History of symptomatic bradyarrhythmias, pericardial constriction, infiltrative cardiomyopathy, cardiac valvular disease Organ or hematologic transplant History of prior surgery, radiation, or stent placement in carotid sinus region History of severe chronic kidney disease Life expectancy to less than one year | 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, Type 2 Diabetes Coronary Artery Disease Obesity Must have one or more of the following: Coronary artery disease (CAD); BMI 25 or higher; Type 2 diabetes Must be sedentary, defined by less than 150 minutes of self-reported activity per week Must be 18 or older Must have access to a computer with an Internet connection, a USB port, and Windows 2000 (latest service pack), XP or Vista Must be a regular email user (checking weekly) Must be able to communicate in English Pregnant Cannot walk a block (self-report) Not competent to sign consent Unable to obtain medical clearance from a treating physician (primary care, cardiologist, endocrinologist) Type 1 diabetes | 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 Subject at high risk for adverse events from carotid endarterectomy due to either anatomic or comorbid conditions who requires carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease Subject with neurological symptoms and greater than or equal to 50% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram OR Subjects without neurological symptoms and greater than or equal to 80% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram Subject has a reference vessel diameter greater than or equal to 4.0 mm and less than or equal to 9.0 mm at the target lesion and a vessel diameter distal to the target lesion of greater than or equal to 3.5 mm and less than or equal to 5.5 mm as optimal "landing zone" for placement of the FilterWire EZ System Subject is willing and able to comply with all follow-up requirements Subject has provided a signed informed consent prior to participation in the Registry Patients in whom anticoagulant and/or antiplatelet therapy is contraindicated Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system Patients with uncorrected bleeding disorders Lesions in the ostium of the common carotid artery | 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 Artery Disease General Subject meets one or more of the high surgical risk criteria Subject is ≥ 18 years old Subject is a candidate for single lesion carotid artery stenting using a femoral arterial approach Subject is willing and able to comply with follow-up evaluations at the specified times Subject (or legal representative) understands the nature of the procedure and provides informed consent, prior to enrollment in the study If female subject, is not currently pregnant and has stated that she has no intention of becoming pregnant during the study. Angiographic (as determined ≤ 30 days prior to procedure) Target lesion stenosis (% stenosis = (1-N/D) X 100)1, documented by selective angiography pre-intervention, is ≥ 80% stenosis for asymptomatic subjects or ≥ 50% stenosis for symptomatic subjects. Symptomatic is defined as carotid stenosis associated with ipsilateral transient or visual TIA evidenced byamaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral ischemic stroke within 6 months prior to enrollment Target lesion is within the internal carotid artery and/or involves the bifurcation of the CCA Subject has participated in, is participating in, or plans to participate in another clinical study that may affect either the pre-procedure or follow-up results Subject has chronic or paroxysmal atrial fibrillation that is not treated by Coumadin Subject has undergone prior stenting of the ipsilateral carotid artery Subject's life expectancy is less than twelve months Subject is unable to respond to external questions and stimuli and to exert a pressure with the contralateral hand Subject is suffering from dementia Subject has documented intolerance to BOTH heparin and Angiomax Subject has an allergy or contraindication to acetylsalicylic acid (ASA) Subject has a documented allergy to the device materials Subject has a documented allergy to radiographic contrast that cannot be pre-treated | 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, Syncope All adult patients (age 18 or older) admitted with syncope or near-syncope Patients who do not speak/read the language of the consent form Prisoners Patients who are of altered mental status or had head trauma Refusal or inability to sign 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): 18.0-80.0, Carotid Stenosis Stenosis of 70% or more by carotid artery duplex, CTA or MRA No evidence of TIA or CVA originating in area of the brain supplied by the carotid artery under study, in the four months preceding treatment for both treatment options: 1. suited for operative treatment as assessed by an anesthesiologist 2. suited for endovascular procedure by established radiological guidelines (including: access to the stenotic area via the vessels of the aortic arch, the absence of occlusion preventing this access, absence of significant atherosclerosis within the arch of aorta, absence of torturous anatomy of the common and internal carotid artery, and absence of thrombus in the area of stenosis) | 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): 40.0-80.0, Carotid Artery Stenosis Atherosclerosis Stroke Unilateral or bilateral carotid artery stenosis that was considered to be severe (carotid artery diameter reduction 70%-79% on ultrasound) This stenosis had not caused any stroke, transient cerebral ischaemia, or other relevant neurological symptoms in the past 6 months Both doctor and patient were substantially uncertain whether to choose immediate CEA, or deferral of any CEA until a more definite need for it was thought to have arisen The patient had no known circumstance or condition likely to preclude long-term follow-up Neurologist's explicit consent to potentially perform CEA Previous ipsilateral CEA Expectation of poor surgical risk (e.g., because of recent acute myocardial infarction) Some probable cardiac source of emboli (because the main stroke risk might then be from cardiac, not carotid, emboli) Inability to provide informed consent Underlying disease other than atherosclerosis (inflammatory or autoimmune disease) Life expectancy < 6 months Advanced dementia Advanced renal failure (serum creatinine > 2.5 mg/dL) Unstable severe cardiovascular comorbidities (e.g., unstable angina, heart failure) Restenosis after prior CAS or 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 The patient must be at least 18 years of age The patient must have a significant diameter reduction of the extracranial or intracranial internal or common carotid artery, defined as ≥50% stenosis for symptomatic patients or ≥80% stenosis for asymptomatic patients determined by carotid duplex ultrasound scan and/or carotid angiography Female patients with child bearing potential must have a negative pregnancy test The patient and the patient's physician must agree to have the patient return for a 30-day and one-year clinical and ultrasound imaging follow-up evaluations as indicated in the protocol Reference vessel diameter ≥ 3.5 mm ≤ 9.0 mm diameter The patient has had a recent (<4 weeks) disabling stroke or dementia with major neurologic deficit (stroke scales: Barthel <60, NIH >15, or Rankin >3) at pre-procedure neuro exam The patient has had within four weeks of the treatment procedure an intracranial hemorrhage, hemorrhage stroke, major stroke, or any stroke with mass effect demonstrated on MRI or CT The patient has a known allergy to heparin, bivalirudin, aspirin or to anti-platelet agents that prevents taking aspirin plus ticlopidine or aspirin plus clopidogrel The patient has received fractionated or unfractionated heparin within 8 hours prior to the procedure The patient has a history of prior life-threatening radiocontrast reaction that cannot be pre-treated The patient has a history of bleeding diathesis or coagulopathy within 3 months The patient is currently participating in another study protocol that may influence either procedure results or follow-up evaluations Plasma/serum creatinine > 3.0 mg/dl at time of intervention Hemodynamic instability at the time of intervention Previous stent placement in the ipsilateral carotid distribution. Angiographic | 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): 16.0-999.0, Low Back Pain low back pain offered routine rehabilitation employed concern about work ability due to low back pain referral by GP in South Nottinghamshire not fluent 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, Acute Ischemic Stroke (AIS) Full functional independence prior to the present stroke (as evidenced by a pre-morbid modified Rankin Scale score of 0-2 Clinical diagnosis of acute stroke with CT scan ruling out intracranial hemorrhage Onset of symptoms within 1-24 hours of commencement of infusion of study drug Measurable deficit on NIHSS (as evidenced by a score of 3-15) Full consciousness (i.e. the score for NIHSS item 1a=0) Written valid informed consent is obtained from the subject or his/her next of kin or legal representative if the subject is fully conscious (i.e. the score for NIHSS item 1a = 0) but unable to read and/or sign the ICF, in accordance with National legislation and local IRB requirements Subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition Subjects with severe illness with life expectancy less than 6 months Body weight in excess of 120 kg Subjects who have received rTPA or other thrombolytics (e.g. urokinase, streptokinase, reteplase, tenecteplase) within the previous 24 hours Likelihood of forbidden concomitant therapy such as vascular surgery, coronary artery bypass graft (CABG), valve replacement, or carotid endarterectomy (CEA) Evidence of cerebral herniation Subjects with confounding neurological diseases such as dementia Subjects with Moya Moya, or carotid dissection Subjects who have experienced a stroke within the previous 3 months (Note: subjects who have recently experienced a TIA, but whose premorbid mRS prior to their stroke is 0-2, will be allowed to enter the study) Evidence from admission imaging tests of infarction involving >1/3 of MCA territory, or entire ACA territory involvement, or internal carotid artery (ICA) occlusions without coexisting separate occlusion of the middle cerebral artery (because of the difficulty distinguishing between chronic and acute ICA lesions in such subjects) | 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): 18.0-120.0, Stroke Cerebral Infarction Vascular Diseases Brain Ischemia Brain Infarction Brain Diseases Cerebrovascular Disorders Patients presenting to Rural Emergency Department within 12 hours of acute stroke symptom onset Written informed consent Unlikely to complete study through 90-day 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): 18.0-999.0, Stroke Carotid Stenosis Subject is at high risk for carotid endarterectomy due to either anatomic or co-morbid conditions; AND Symptomatic patients (TIA or non-disabling stroke within 6 months of the procedure), with carotid stenosis ≥ 50% as diagnosed by angiography, using methodology (50); OR Asymptomatic patients with carotid stenosis ≥ 80% as diagnosed by angiography, using methodology Conditions that interfere with the evaluation of endpoints Subject has anticipated or potential sources of cardiac emboli Subject plans to have a major surgical procedure within 30 days after the index procedure Subject has intracranial pathology that makes the subject inappropriate for study participation Subject has a total occlusion of the ipsilateral carotid artery (i.e., CCA) Severe circumferential lesion calcification that may restrict the full deployment of the carotid stent Carotid stenosis located distal to the target stenosis that is more severe than the target stenosis | 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, Atherosclerotic Disease, Carotid 79% stenosis of the carotid artery age 18 or older no ischemic neurovascular symptoms within preceding 6 months contraindication to MRI (e.g. weight > 130 kg, pregnancy) prior or planned carotid endarterectomy or stenting history of atrial fibrillation prior neck irradiation | 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, Coronary Artery Bypass Myocardial Infarction Ventricular Dysfunction, Left Stroke Cardiopulmonary Bypass A high risk participant undergoing non emergency CABG surgery requiring CPB and cardioplegia Age: >=50 years At least one of the following risk factors Female (but not pregnant or lactating), or History of prior CABG, or History of myocardial infarction (MI), or History of ischemic stroke, or Left ventricular ejection fraction <=30%, or Diabetes mellitus requiring insulin and/or antidiabetic agents Significant coronary artery stenosis Planned valve replacement, carotid artery or aortic surgery, distal coronary endarterectomy,surgical ablation for cardiac arrhythmia, or ventricular aneurysmectomy, alone or with CABG surgery (repair for mild to moderate mitral valve disease with concomitant CABG is not excluded) Planned or staged major surgery within 30 days of CABG surgery CABG surgery using intermittent aortic cross clamping without cardioplegia Minimally invasive surgery (ie, without use of CPB) MI within 5 days prior to surgery Pre-operative or planned intra operative/postoperative use of intra-aortic balloon pump (IABP), ventricular assist device (VAD), extra-corporeal membrane oxygenator (ECMO), or other mechanical hemodynamic assist device History or presence of gout or uric acid nephrolithiasis Serum creatinine >2 mg/dL (180 µmol/L) Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 x Upper Limit of Normal (ULN) Adenosine, aminophylline, nicotinic acid, pentoxifylline, theophylline, and any cardioplegia solution containing adenosine, dipyridamole or lidoflazine within 24 hours before 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): 18.0-999.0, Carotid Stenosis Carotid artery stenosis detectable by duplex ultrasound, with no ipsilateral carotid territory symptoms(or none for some months) and no previous procedure done on it, which might well need procedural treatment now with CEA or CAS Already started any appropriate medical treatment (eg, statin, aspirin etc), and already recovered from any necessary coronary procedures (eg, CABG) Patient seems fit and willing for follow-up in person (at 1 month) and by annual letter (for at least 5 years) Investigations show that both procedures (CEA and CAS) appear to be practicable and appropriate Some type of angiography (eg, MRA or CTA) has already been done that has shown that CEA and CAS would both be anatomically practicable Doctor and patient both substantially uncertain about whether to treat with CEA or CAS, and the doctor sees no clear indication/contra-indication for either procedure Small likelihood of worthwhile benefit (eg, very low risk of stroke because stenosis is very minor, or major co-morbidity or life-threatening disease, such as advanced cancer) Unsuitable for one or other procedure (eg, stenosis at carotid siphon that is inaccessible for CEA, or complex vasculature below the stenosis that would hinder CAS, or patient unfit for major surgery) | 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, Postherpetic Neuralgia Diabetic Neuropathy Complex Regional Pain Syndrome Carpal Tunnel Syndrome HIV Neuropathy Idiopathic Sensory Neuropathy Peripheral Neuropathy Had a diagnosis of PHN, DN, CRPS, carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or other peripheral neuropathy (upon mutual agreement of the sponsor and investigator) 2. Patients with PHN must have had pain >3 months after rash healing 3. Patients with DN must have had Type I or II diabetes and painful distal symmetric sensorimotor polyneuropathy with or without dynamic allodynia of the lower extremities 4. Patients with CRPS must have met current IASP (International Association for the Study of Pain) diagnostic 5. Patients with carpal tunnel syndrome must have had a diagnosis by combination clinical neurological examination (e.g., Phalen's and Tinel's signs), electrodiagnostic testing, and daily painful symptoms of at least 3 months' duration 6. Patients with HIV neuropathy must have had HIV, subjective symptoms of painful peripheral neuropathy, and daily painful symptoms of at least 3 months' duration 7. Patients with idiopathic sensory neuropathy must have had pain of at least 3 months' duration 8. Reached an average daily pain rating during the baseline week of pain ratings greater than 4 on the 0-to-10 numerical pain rating scale (Question 5 of the BPI) 9. Had never received an analgesic regimen that contained lidocaine or gabapentin Had a neurological condition other than that associated with their pain diagnosis which, in the opinion of the investigator, would interfere with their ability to participate in the study 2. Were taking a lidocaine-containing product that could not be discontinued while receiving lidocaine 3. Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide) | 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, Coronary Artery Disease Postoperative Cognitive Dysfunction Neurological Impairment All patients with coronary artery disease undergoing coronary artery bypass grafting (CABG) with cardiopulmonary bypass Who refuse to participate Previous stroke Preexisting psychiatric disease Significant carotid stenosis Ejection fraction below 25% Reoperations Emergent surgery Dialysis | 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, Cognitive Function in Carotid Stenting 80 years of age Right hand dominate Asymptomatic:defined as: no symptoms of TIA/stroke in the previous 6 months Baseline doppler study with a peak systolic velocity of 400cm/sec Patient is deemed candidate for carotid artery stenting TIMI flow of 1,2 or 3 or greater stenosis of distal common or internal carotid artery, as determined angiographically, as defined in ACAS Subjects are able to give informed consent Subjects are willing/able to complete follow-up visits History of major stroke: within the past 6 months History of Alzheimers disease or Dementia Unable or willing to complete the baseline and 20 days neuro-cognitive testing planned major surgery within the next 2 months Planned intervention opposite carotid artery within 2 months Ineligibility for carotid stent procedure due to anatomy, thrombus, or inability to complete anti-platelet therapy Any individual identified with cognitive impairment which would affect their performance during cognitive testing | 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, Intracranial Tumor Adult ≥ 18 years old Able to comprehend, sign, and date the written informed consent document to participate in the clinical trial Scheduled for "procedure" ASA Class I, II or III as assigned by the anaesthesiologist Allergy or inability to tolerate "product" Body weight less than 70% or more than 130% of ideal body weight Pregnant or nursing females Participation in a clinical trial within the past 30 days Congenital mental disability or congenital anatomical brain abnormality A medical history of cerebrovascular accident or thrombosis A medical history of carotic artery occlusive pathology A medical history of degenerative cerebral pathology (MS, Dementia, ALS, para-or tetraplegia due to a traumatic disruption of the spinal cord) A medical history of severe psychiatric pathology (Schizophrenia, severe depression, alcoholism, drug abuse) Mild depression evoked by coping with the diagnosis of cancer is not excluded Patients with a history of epileptic insults. Patients receiving preventive anti-epileptic treatment due to the tumoral process are not 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): 40.0-80.0, Type 2 Diabetes Type 2 diabetic patients who had multiple cardiovascular risk factors were recruited Patients who had atypical chest pain, EKG abnormality (ischemic ST-T changes or abnormal Q-wave), or history of previous cardiovascular disease were also included Acute coronary SD, serum Cr>1.4 mg/dL, history of allergy to iodinated contrast dye were 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): 18.0-999.0, Coronary Artery Disease Age 18 years of older Angiographically confirmed multivessel CAD [critical (>70%) lesions in at least two major epicardial vessels and in at least two separate coronary artery territories (LAD, LCX, RCA)] and amenable to either PCI or CABG Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia Geographically accessible and willing to come in for required study visits Signed informed consent Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stent) In-stent restenosis of a target vessel Prior CABG surgery Prior PCI with stent implantation within 1 year Two or more chronic total occlusions in major coronary territories Acute ST-elevation MI(Q-wave) within 72 hours prior to enrollment requiring revascularization Abnormal creatine kinase (CK > 2x normal) and/or abnormal CK-MB levels and/or elevated Troponin levels at time of randomization Previous stroke within 6 months or patients with stroke at more than 6 months with significant residual neurologic involvement, as reflected in a Rankin Score > 1 Dementia with a Mini Mental Status Examination (MMSE) score of ≤ 20 | 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): 55.0-999.0, Carotid Atherosclerosis Male/Female patients who are 55yrs or older and for whom carotid endarterectomy is clinically indicated and a decision has been made to perform a carotid endarterectomy Normal liver and adequate renal function. Assessed by measuring eGFR (>50ml/min) and creatinine (<130μmol/L) Life expectancy > 12 weeks Patients should be able to tolerate head/neck mask as well as lying in the PET-CT scanner Abnormal liver and renal function (eGFR <50ml/min, Creatinine >130μmol/L) Patient unwilling to provide written informed consent | 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): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs | 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, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin | 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): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination | 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): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also 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): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy | 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): 18.0-80.0, Coronary Artery Disease Two or three-vessel disease, left main disease, or LM equivalent with 2 or 3-vessel disease (left anterior descending [LAD], left circumflex [LCX], right coronary artery [RCA] territory) LAD diseases not suitable for PCI [i.e. chronic totally occlusion (CTO), severe calcification or/and angulated lesions, bifurcation or trifurcation lesions] Angiographic characteristics of non-LAD lesion(s) amiable to PCI Chronic stable or unstable angina pectoris of CCS 2 or greater (symptoms of angina and/or objective evidence of myocardial ischemia) Evaluated by both cardiac surgeon and cardiologist together Need for emergent CABG Prior CABG Prior PCI with stenting within 6 months of study entry Stroke with 6 months of study entry Overt congestive heart failure Need for a concomitant operation (i.e. valve repair or replacement, Maze surgery) Hemodynamic instability Situations in which complete revascularization is not possible served Allergy to radiographic contrast, aspirin or clopidogrel Contradictions to PCI: Occluded coronary vessels, PVD, Unable to achieve access, Fresh thrombus, Vessels <1.5mm; Intolerance to aspirin or both clopidogrel and ticlopidine | 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, Heart Disease Myocardial Ischaemia Coronary Disease Coronary Artery Disease Age 18 or more Angiographically confirmed multivessel CAD with involved LAD and critical (>70%)lesion in at least one (apart LAD) major epicardial vessel amenable to both PCI and CABG Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischaemia Patient is willing to comply with all follow-up visits Patient signed an Informed Consent Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema, cardiogenic shock) at the time of enrollment Prior surgery with the opening of pericardium or pleura Prior stroke (within 6 months)or more than 6 months if there are substantial neurological defects Prior history of significant bleeding (within previous 6 months) that might be expected to occur during PCI/CABG related anticoagulation One or more chronic total occlusions in major coronary territories Left main stenosis (at least 50% diameter stenosis) Acute ST-elevation MI within 72 hours prior to enrollment requiring revascularization Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting) Contraindication to either CABG, or PCI/DES because of a coexisting clinical condition Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis | 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): 19.0-100.0, Cardiovascular Risk Factors Age ≥ 65 years 2. Hypertension (HTN) 3. Diabetes 4. Obesity (body mass index [BMI] >35) 5. Renal insufficiency 6. Tobacco usage 7. Hypercholesterolemia 8. Sleep apnea/heavy snoring at night 9. Clinical diagnosis of CHF as defined by: 1. Dyspnea on exertion 2. Paroxysmal nocturnal dyspnea 3. Orthopnea 4. Elevated jugular venous pressure 5. Pulmonary rales 6. Third heart sound 7. Cardiomegaly or pulmonary edema on chest x-ray 8. Peripheral edema 9. Hepatomegaly 10. Pleural effusion 10. Palpitations/irregular heart beats 11. Chest pain at rest and or exercise 12. Murmur on examination 13. Known coronary artery disease (CAD)/stents/coronary artery bypass graft (CABG) 14. Known valvular disease 15. Known stroke or transient ischemic attacks (TIA) Patients expected to say in the hospital for less than 24 hours. 2. Inability of undergo TEE and TTE 3. Clinical evidence or suspicion of elevated intracranial pressure. 4. Preoperative shock or systemic sepsis 5. Emergency Operation 6. ASA Class V 7. Inability of give informed consent 8. Participation in another clinical trial 9. Prisoner | 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): 75.0-999.0, Aortic Valve Stenosis > 74 years old Symptomatic failing bioprosthetic aortic valve (stenotic, incompetent or mixed) confirmed by Doppler echocardiography Logistic EuroSCORE > 15%, or Any of the following 1. Left ventricular ejection fraction (LVEF) < 20%, 2. Creatinine clearance < 20mL/min (estimation using the Cockcroft calculation), 3. Renal failure requiring dialysis, 4. Permanent and long lasting (> 6 month duration) atrial fibrillation, 5. Cirrhosis of the liver (Child class A or B), 6. Respiratory impairment (FEV1 < 1L), 7. Previous cardiac surgery (i.e., CABG especially if patient had competent mammary arteries on left anterior descending (LAD) artery or occluded saphenous veins with high-risk of coronary embolism during re-operation), 8. Pulmonary hypertension ³ 60mmHg, 9. Recurrent pulmonary embolus, 10. Moderate tricuspid (< grade 2+) insufficiency, 11. Any severe disease contraindicating surgery, 12. Calcified aorta (porcelain aorta), 13. Recent myocardial infarction (less than 30 days at baseline), 14. Contraindication for cardiopulmonary bypass Inner diameter of the failing bioprosthetic aortic valve (homograft or stented or stentless heterograft) of ³ 19mm and < 26mm as determined by Doppler echocardiography Signed informed consent form Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine and clopidogrel, Nitinol, or sensitivity to contrast media which cannot be pre-medicated Active infection or endocarditis Any intra left ventricular mass, thrombus or vegetation evidenced by Doppler echocardiography Mitral or tricuspid valvular insufficiency ³ grade 2+ Prosthetic mitral or tricuspid valve Femoral and/or iliac and/or aortic vascular condition (stenosis, occlusion or tortuosity) that could complicate endovascular access to the aortic valve bioprosthesis Symptomatic carotid or vertebral artery narrowing (> 70%) disease Aortic abdominal or thoracic aneurysm Bleeding diathesis or coagulopathy, or patient refuses blood transfusion Active peptic ulcer or has had upper gastrointestinal bleeding within the past 3 months before baseline | 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): 50.0-85.0, Symptomatic Carotid Stenosis Hypercholesterolemia Indication for Carotid Endarterectomy Symptomatic carotid stenosis > 70% (NASCET criteria) for carotid endarterectomy Total cholesterol level between 5.83 and 7.64 mmol/L Never treated with lipid lowering drugs Previous lipid lowering therapy Total cholesterol <5.83 or >7.64 mmol/L Evidence of chronic inflammatory disease (clinical and laboratory) Patients at high risk for cerebrovascular events (i.e. ulcerated carotid plaque, recurrent TIAs) | 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 Diabetic Neuropathy Symmetrical painful diabetic peripheral neuropathy History of hypersensitivity, allergy or contraindication to opioids and acetaminophen Confounding painful conditions Significant vascular disease History or risk of seizure Chronic disease that might effect drug absorption, distribution, metabolism, or excretion Female subjects who are being pregnant or breastfeeding Evidence or history of alcohol, medication, or drug abuse | 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): 49.0-80.0, Carotid Stenting every patient with carotid stenting presence of hemodynamic instability and low BP at baseline atrial fibrillation unstable patients with recent TIA and CVA in last week inability of patient to hold respiration for 30 seconds refusal of 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): 18.0-999.0, Diabetic Neuropathy, Painful Diabetic Polyneuropathy Man or woman aged 18 years or older Patients with Type 1 or 2 diabetes mellitus must have a documented clinical diagnosis of painful diabetic peripheral neuropathy with symptoms and signs for at least 6 months, and pain present at the time of screening Diagnosis must pain plus reduction or absence of pin sensibility and/or vibration sensibility on Total Neuropathy Score Nurse (TNSn) examination in lower and/or upper extremities at screening The investigator considers the patient's blood glucose to be controlled by diet, or hypoglycemics, or insulin for at least 3 months prior to enrolling in the study (this control should be documented by figures of glycated hemoglobin (HbA1c) no greater than 11% at screening) Patients have been taking analgesic medications for the condition for at least 3 months prior to screening (patients taking opioid analgesics must be dissatisfied with current treatment, and patients taking non-opioid analgesics must be dissatisfied with current analgesia) Patients currently requiring opioid treatment must be taking daily doses of an opioid-based analgesic equivalent to <=160mg of oral morphine Patients with baseline score for average pain intensity in the previous 24 hours of =>4 on the 11-point numerical rating scale (NRS) at the beginning of the titration period Significant pulmonary, gastrointestinal, endocrine, metabolic (except diabetes mellitus), neurological, psychiatric disorders (resulting in disorientation, memory impairment or inability to report accurately as in schizophrenia, Alzheimer's disease) History of moderate to severe hepatic impairment Severely impaired renal function Clinically significant laboratory abnormalities Clinically significant cardiac disease History of seizure disorder or epilepsy History of any other clinically significant disease that in the investigator's opinion may affect efficacy or safety assessments or may compromise patient safety during study participation | 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): 60.0-999.0, Diabetes Cataract Cataract, diabetes Corneal disease Uveitis Previous intraocular surgery and diabetes type I | 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, Small-Fiber Neuropathy Chronic Kidney Disease The patients should fulfill the of CKD according to renal function study and the patients of end-stage renal disease should receive regular dialysis therapy and follow-up at outpatient clinics For disease comparison, patients with peripheral neuropathy of variable etiologies will also be recruited Poor control DM Severe heart failure Bleeding tendency Severe lung disease with respiratory distress Severe infection Alcoholism Amyloidosis Poor wound healing history | 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): 40.0-75.0, Acute Coronary Syndrome Myocardial Infarction Unstable Angina Pectoris Participant had at least five minutes of chest pain or equivalent (chest tightness; pain radiating to left, right, or both arms or shoulders, back, neck, epigastrium, jaw/throat; or unexplained shortness of breath, syncope/presyncope, generalized weakness, nausea, or vomiting thought to be of cardiac origin) at rest or during exercise within 24 hours of ED presentation, warranting further risk stratification, as determined by an ED attending. 2. 2 or more cardiac risk factors (diabetes, hypertension, hyperlipidemia, current smoker and family history of coronary artery disease). 3. Able to provide a written informed consent. 4. <75 years of age, but >40 years of age. 5. Able to hold breath for at least 10 seconds. 6. Sinus rhythm New diagnostic ischemic ECG changes (ST-segment elevation or depression > 1 mm or T-wave inversion > 4 mm) in more than two anatomically adjacent leads or left bundle branch block 2. Documented or self-reported history of CAD (MI, percutaneous coronary interventions [PCIs], coronary artery bypass graft [CABG], known significant coronary stenosis [>50%]) 3. Greater than 6 hours since presentation to ED. 4. BMI >40 kg/m2 5. Impaired renal function as defined by serum creatinine >1.5 mg/dL* 6. Elevated troponin-T (> 0.09 ng/ml) 7. Hemodynamically or clinically unstable condition (BP systolic < 80 mm Hg, atrial or ventricular arrhythmias, persistent chest pain despite adequate therapy) 8. Known allergy to iodinated contrast agent 9. Currently symptomatic asthma 10. Documented or self-reported cocaine use within the past 48 hours (acute) 11. On Metformin therapy and unable or unwilling to discontinue for 48 hours after the CT scan 12. Contraindication to beta blockers (taking daily antiasthmatic medication): This only applies to patients with a heart rate >65 bpm at sites using a non-dual source CT scanner 13. Participant with no telephone or cell phone numbers or no address (preventing follow-up) 14. Participant with positive pregnancy test. Women of childbearing potential, defined as <2 years of menopause in the absence of hysterectomy or tube ligation, must have a pregnancy test performed within 24 hours before the CT scan. 15. Participant unwilling to provide a written informed 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): 18.0-999.0, Coronary Artery Disease Left Ventricular Dysfunction Sudden Cardiac Death Evidence of Coronary Artery Disease (CAD) a or documented prior Myocardial Infarction. 2. LVEF >35% by any current standard evaluation technique (e.g.,) echocardiogram, MUGA, angiography). 2.1. Patients who have an LVEF between 30-35% and NYHA Class I heart failure who do not have history of ventricular tachyarrhythmias,or inducible ventricular tachycardia during electrophysiological (EP) testing can be enrolled. 3. If documented prior MI is not present, evidence of mild-moderate systolic Left Ventricular Dysfunction with an EF >35 ≤50% as measured by any current standard screening technique (e.g.,echocardiogram, MUGA, angiography) must be present. 4. Patients aged 18 years or above 1. CAD will be defined as evidence of one of the following two (2) Significant stenosis of a major epicardial vessel (>50% proximal or 70% distal) by coronary angiography Prior revascularization (percutaneous coronary intervention or coronary artery bypass surgery) 2. MI can be documented in the following ways From the MI hospitalization: Detection of a rise and fall of cardiac biomarkers > 99th percentile of lab (e.g., CPK elevation or Troponin at least > two times the upper limit of normal) together with myocardial ischemia with at least one of the following Symptoms of Ischemia ECG changes indicative of new ischemia (new ST-T changes or new LBBB) Development of pathological Q waves Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality If no report from the MI hospitalization is available, prior MI can be met by either of the following History of cardiac arrest or spontaneous or inducible sustained VT (15 beats or more at a rate of 120 BPM or greater the occurrence of cardiac arrest or spontaneous VT in the setting of an acute MI is not considered an exclusion). 2. Unexplained syncope 3. Current or planned implantable cardiac defibrillator (ICD) 4. Any condition other than cardiac disease that, in the investigator's judgment, would seriously limit life expectancy (poor survival) 5. Metastatic cancer 6. Marked valvular heart disease requiring surgical intervention 7. Current or planned cardiac, renal or liver transplant 8. Current alcohol or drug abuse 9. Unwilling or unable to provide informed consent 10. LVEF <35% with Class II-IV CHF or LVEF <30% 11. Participation in a clinical trial where the active treatment arm is testing an agent and/or intervention with known antiarrhythmic properties | 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): 35.0-90.0, Coronary Artery Disease Chest Pain Cardiovascular Diseases Coronary Heart Disease Angina Pectoris CAD CVD CHD Ages 45-90 for women; 35-90 for men Stable chest pain syndrome (typical or atypical) or anginal equivalent in the judgment of the investigator (e.g., pain in the neck, jaw, arm or shoulder or dyspnea possibly due to cardiac ischemia) Referred for a stress test using MPI The patient has signed the appropriate Institutional Review Board approved Informed Consent Form History of known MI or significant CAD Current MI or acute coronary syndrome Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms Severe regurgitant or stenotic cardiac valvular lesion Severe left ventricular systolic dysfunction (LVEF ≤ 35 % documented in the last year); if no assessment was performed or documented in the year preceding enrollment, presume normal LVEF Active systemic infection (diagnosed by a combination of clinical symptoms and laboratory testing, including but not limited to fever, leukocytosis, positive blood cultures, pneumonia, urinary tract infection, or abscess in the preceding 2 months) or chronic infection (e.g., HIV, Hepatitis B or C, Tuberculosis) Protocol-specified rheumatologic, autoimmune or hematologic conditions (e.g., rheumatoid arthritis, systemic lupus erythematosis, polymyalgia rheumatica, or systemic sarcoidosis) Known or suspected diabetes mellitus or documented Hemoglobin A1c (HbA1c) ≥ 6.5; presume normal HbA1c if none documented Total WBC ≥ 11,000 cells/ul and platelet count ≤ 75,000 cells/ul from a CBC with differential drawn within 7 days prior to enrollment [WBC ≥ 11,000 cells/ul and platelet count ≤ 75,000 cells/ul from a CBC drawn > 7 days prior need to be re-drawn at enrollment] Recipient of any organ transplant | 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 The following apply to Cohort 2 PCI patients only Signed informed consent, release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documents Age 18 years or older Clinical indication for revascularization LAD and at least one additional vessel coronary disease (> 70% stenosis) confirmed by angiogram Clinical characteristics and multi-vessel disease amenable to both PCI with DES and Hybrid as adjudicated by one interventional cardiologist and one cardiac surgeon Ability to tolerate and no plans to interrupt double platelet therapy for ≥ 12 months Ability to tolerate to single lung ventilation in the judgment of the investigator Willing to comply with all protocol required follow-up Previous coronary stent within month prior to enrollment for bare metal stent (BMS) or months prior to enrollment for DES Evidence of in stent restenosis of a DES or BMS Previous cardiac surgery of any kind Chronic total occlusion (CTO) in LAD or ≥ 2 CTOs in major coronary territories that are considered targets for revascularization Left main disease ≥ 50% stenosis Presence of fresh coronary thrombus Need for concomitant vascular or other cardiac surgery during the index hospitalization (including, but not limited to, valve surgery, aortic resection, left ventricular aneurysm, carotid endarterectomy or stenting, etc) Previous STEMI within 30 days prior to randomization | 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 Artery Disease Carotid Stenosis Stroke 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 Target lesion located in the common carotid artery (CCA), internal carotid artery (ICA), or carotid bifurcation Arterial segment to be stented has a diameter between 4mm and 9mm Age ≥ 18 years Life expectancy > 12 months from the date of the index procedure Contraindication to percutaneous transluminal angioplasty (PTA) Severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system Lesions in the ostium of the common carotid artery Occlusion of the target vessel Evidence of intraluminal thrombus Known sensitivity to nickel-titanium Known allergy to heparin, aspirin or other anticoagulant/ antiplatelet therapies, or is unable or unwilling to tolerate such therapies Uncorrectable bleeding disorders, or will refuse blood transfusions History of prior life-threatening contrast media reaction Previous stent placement in the target vessel | 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): 45.0-999.0, Chest Pain new or worsening chest pain suspicious for clinically significant coronary artery disease (CAD) no prior evaluation for this episode of symptoms planned non-invasive testing for diagnosis men age ≥55 years men age ≥45 years with increased probability of coronary artery disease (CAD) due to either (A. Diabetes Mellitus (DM) requiring medical treatment OR Peripheral Arterial Disease (PAD) defined as documented >50% peripheral arterial stenosis treated medically or invasively OR cerebrovascular disease (stroke, documented > 50% carotid stenosis treated medically or invasively) OR B. At least one of the following cardiovascular risk factors: 1-Ongoing tobacco use, 2-Hypertension, 3-Abnormal ankle brachial index (ABI) defined as less than <0.9, 4-Dyslipidemia women age ≥65 years women age ≥50 years with increased probability of coronary artery disease (CAD) due to either (A. Diabetes Mellitus (DM) requiring medical treatment OR Peripheral Arterial Disease (PAD) defined as documented >50% peripheral arterial stenosis treated medically or invasively OR cerebrovascular disease (stroke, documented > 50% carotid stenosis treated medically or invasively) OR B. At least one of the following cardiovascular risk factors: 1-Ongoing tobacco use, 2-Hypertension, 3-Abnormal ankle brachial index (ABI) defined as less than <0.9, 4-Dyslipidemia Serum creatinine ≤ 1.5 mg/dL within the past 90 days Negative urine/serum pregnancy test for female subjects of child-bearing potential Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization or urgent or emergent testing; Elevated troponin or creatine kinase-myocardial band (CK-MB) Hemodynamically or clinically unstable condition systolic blood pressure (BP) < 90 mmHg, atrial or ventricular arrhythmias, or persistent resting chest pain felt to be ischemic despite adequate therapy) Known coronary artery disease (CAD) with prior Myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or any angiographic evidence of coronary artery disease (CAD) ≥50% lesion in a major epicardial vessel Any invasive coronary angiography or non-invasive anatomic or functional cardiovascular (CV) test for detection of coronary artery disease (CAD), including coronary tomographic angiography (CTA) and exercise electrocardiogram (ECG), within the previous twelve (12) months Known significant congenital, valvular (> moderate) or cardiomyopathic process (hypertrophic cardiomyopathy or reduced systolic left ventricular function (LVEF) ≤ 40%)) which could explain cardiac symptoms Contraindication to undergoing a coronary tomographic angiography (CTA), including but not limited to: a. Allergy to iodinated contrast agent, b. Unable to receive beta blockers unless heart rate < 65 beats per minute, c. Pregnancy Life expectancy < 2 years Unable to provide written informed consent or participate in long-term 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): 40.0-80.0, Stroke TIA Coronary Stenosis Criteria:Patients referred for elective Carotid Artery Stenting were participate in the study at the time of scheduling for operation. 1. Symptomatic patient, as evidenced by transient ischemic attack (TIA), amaurosis fugax, minor or non-disabling stroke(in the hemisphere supplied by the target vessel), within 180 days of the randomization date. 2. Discrete lesion located in the internal carotid artery(ICA), and the degree of carotid stenosis ≥50% defined as: Stenosis ≥70% by ultrasound. Stenosis ≥50% by angiography (based on Criteria) 3. Appropriate for carotid stenting. Candidates for Carotid Artery Stenting meet all other requirements Evolving stroke 2. Untoward reaction to anesthesia 3. Intolerance or allergic reaction to associated medications, including aspirin(ASA) and clopidogrel. 4. Prior major ipsilateral stroke that may confound study endpoints. 5. Severe dementia. 6. Hemorrhagic transformation of an ischemic stroke within the past 60 days. 7. Chronic atrial fibrillation. 8. MI within previous 30 days. 9. High risk surgical candidate defined as the CREST test. 10. Bilateral upper limb arteries are severe stenotic or occlusion | 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): 45.0-80.0, LUNG DISEASES, OBSTRUCTIVE COPD on necessity of long term oxygen therapy Able to give their written consent Unstable patients with COPD Patients with restrictive respiratory disease Patients with cardiac or neurologic disease contre-indicating the different evaluations | 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, Peripheral Neuropathy Clinical diagnosis of diabetes induced peripheral neuropathy, other peripheral neuropathies (Idiopathic, nutritional and metabolic nature of entrapment neuropathy). 2. Significant spontaneous pain and / or numbness and other symptoms of neuropathy. TSS (Total Symptom Score) >=7.5. 3. Participation in clinical trials voluntarily and signed informed consent form Pregnancy, preparation for pregnancy or breast-feeding women 2. Peripheral neuropathy caused by drugs, poisoning, cancer or genetic 3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST): 2.0 times more than the upper limit of normal; Creatinine (Cr) 1.5 times above the upper limit of normal. 4. Serious organ disease or other serious primary disease merger, the mentally ill, poorly controlled hypertension (blood pressure more than 150/100 mmHg after using antihypertensive drugs) 5. Diagnosis of patients with diabetic peripheral neuropathy, but has diabetes ketosis, ketoacidosis and severe infection within the past two weeks 6. Bleeding or bleeding tendency in 2 months 7. Have allergy 8. Noncompliance or cannot meet those 9. Participation in other clinical trials in the last 3 months 10. Participant unsuitable to participate in this test as investigator considering | 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): 3.333-80.0, Carotid Stenosis Carotid Artery Diseases Stroke Vascular Diseases Carotid artery stenosis detectable by duplex ultrasound, and no previous procedure done on it, which might well need procedural treatment now with CEA or CAS Already started any appropriate medical treatment (eg, statin, aspirin etc), and already recovered from any necessary coronary procedures (eg, CABG) Patient seems fit and willing for follow-up in person (at 1 month) and by annual letter (for at least 5 years) Some type of angiography (eg, MRA or CTA) has already been done that has shown that CEA Small likelihood of worthwhile benefit (eg, very low risk of stroke because stenosis is very minor, or major co-morbidity or life-threatening disease, such as advanced cancer) | 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): 60.0-999.0, TIA Stroke Carotid Artery Stenosis Age 60 or greater at time of enrollment Written informed consent from patient or legal representative Diagnosis of stroke or TIA made by a stroke specialist within 90 days and fulfilling the following A TIA must involve a focal speech/language, motor or visual deficit (transient monocular blindness, amaurosis fugax) referable to the distribution of a carotid artery and lasting less than 24 hours A stroke consisting of deficits as noted above with duration greater than 24 hours and/or confirmed on cerebral imaging. Post event Modified Rankin Score of 2 or less Stroke meets the Trial of ORG 10172 in Acute Stroke Treatment (TOAST) for large artery atherosclerosis Carotid Doppler, CTA or MRA confirming the presence of bilateral atherosclerotic disease resulting in carotid stenosis of any degree. Stenosis will be measured following the method used in for CTA and MRA. Carotid Doppler measurements will follow the defined by the Society for Ultrasound consensus conference lead ECG or Holter monitor confirming the absence of atrial fibrillation TIA or stroke in the vertebrobasilar system Index event was primary hemorrhage History of intermittent atrial fibrillation Cardiac source of embolus suspected as cause of index event (artificial valve, segmental or global LV dysfunction, congenital cardiac defect) Diagnosis of vasculitis, dissection, or non-atherosclerotic carotid disease (Ehlers-Danlos, Marfans) Sinovenous thrombosis, endocarditis or hypercoagulable state Pacemaker, ICD or other contraindications to MRI Diminished Kidney Function Contraindication to radiation exposure (eg: pregnancy) Severe Claustrophobia | 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, Stroke Phase I Safety (healthy volunteers) Presence of temporal windows as measured first by an FDA-approved diagnostic TCD device Age ≥ 18 years old Signed informed consent. Phase II (0-3 hours ischemic stroke patients) Disabling focal neurological deficit (NIHSS > 4 points) No evidence of hemorrhage on non-contrast head CT scan Intravenous rt-PA (0.9 mg/kg, 10% bolus 90% infusion over 1 hour, maximum dose 90 mg) infusion initiated within 3 hours of symptom onset Diagnostic TCD completed and HF-TCD placed before rt-PA bolus Diagnostic TCD confirms intracranial arterial occlusion of the middle cerebral artery (MCA), anterior cerebral artery (ACA), internal carotid artery (ICA), posterior cerebral artery (PCA) or distal basilar artery Age ≥ 18 years old Phase I Safety (healthy volunteers) History of any neurological disease affecting the central nervous system Lack of temporal windows History of renal disease or glomerular filtration rate (GFR) < 60 Contraindication to MRI (e.g., pacemaker, spinal cord stimulator, severe claustrophobia) Phase II (0-3 hours ischemic stroke patients) Absent temporal windows in patients with anterior circulation ischemia Intra-arterial thrombolysis Patient refusal to give informed consent to participate in the trial Contraindications for intravenous rt-PA (NINDS rt-PA Stroke Study Protocol)2 Phase II (3-6 hours ischemic stroke patients) | 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): 45.0-80.0, In-stent Restenosis After Carotid Artery Stenting or more symptomatic carotid artery stenosis or 80% or more asymptomatic carotid artery stenosis scheduled for carotid artery stenting within 30 days or more years-old and less than 80 years old antiplatelet agents can be administratered orally follow-up is anticipated possible for 2 years after CAS self-supporoted in daily activities (modified Rankin Scale 2 or less) patients who have given informed consent to participation in the study received endovascular interevention scheduled for bilateral carotid intervention aortitis or cvasculitis congessive heart failure ischemic stroke within 48 hours hemorrhagic stroke within 90 days renal failure | 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, Subclavian Steal patients who revealed subclavian steal in the duplex study patients who has vascular access in the arm instead of the forearm | 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 Patient (male or non-pregnant female)must be > than or= 18 Qualifying non-invasive test (ultrasound or MRA) was performed less than 60 days prior to study entry. Carotid duplex study revealed Stenosis > or = to 50% in symptomatic patients Stenosis > or = to 60% in asymptomatic patients Target lesion may be in the common or internal carotid artery and is amenable to treatment with angioplasty and stenting Patients taking warfarin may be included if their dosage is reduced before the procedure to result in an INR of 1.5 or less and a Prothrombin time of 15 seconds. Warfarin may be started after the procedure Female patients of childbearing potential must have a documented negative pregnancy test during index hospitalization Patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local institutional review board or medical ethics committee (Patients will be excluded from the study if ANY of the following conditions are present) There is total occlusion of the target carotid artery treatment site The patient has an allergy or contraindication to aspirin, ticlopidine, clopidogrel, bivalirudin, nickel, titanium, or a sensitivity to contrast media, which cannot adequately pre-medicated The subject has a platlet count< 100,000 cells/mm3 or 700,000 cells/mm3 or a WBC of < 3,000 cells/mm3 Stroke within 7 days prior to the procedure NIH stroke score > or = to 15 within 7 days prior to the procedure The patient has experienced a significant GI bleed within 6 months prior to study procedure The patient has active internal bleeding The patient has had major surgery or serious trauma within 6 weeks before enrollment The patient has excessive peripheral vascular disease that precludes safe sheath insertion | 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): 18.0-85.0, Carotid Stenosis -patients with monolateral, significant, soft carotid stenosis patients with controlateral carotid occlusion patients with critic stenosis of the external carotid | 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, Heart; Dysfunction Postoperative, Cardiac Surgery Age 18 years or older Weigh at least 40 kg Undergoing Coronary Artery Bypass Graft (CABG) and/or valvular surgery requiring the use of Cardio Pulmonary Bypass (CPB) or Left Ventricular Assist Device (LVAD), inclusive of any concomitant procedure Willing and able to provide informed consent Able to communicate and read in English Emergency procedure such that informed consent may not be obtained Known cognitive impairment, history of delirium or dementia Known hemodialysis or fistula graft Delirium Observation Score (DOS) Score of >6 prior to surgery Pre-existing skin condition at the site of sensor application (e.g. eczema, dermatitis) Any known contraindication or sensitivity to the cerebral oximeter sensor | 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, Carcinoma Community health center in the Saint Louis Metropolitan Area, including Southern Illinois Participant in Partnership Planning Process Affiliated with the Washington University Program for the Elimination of Cancer Disparities Primary patient population has private health insurance Not in an medically underserved area | 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, Squamous Cell Carcinoma of the Head and Neck Untreated, suspected or histologically documented locally advanced clinical stage III or IVa-b(M0)SCCHN, no evidence of distant metastases. Prior surgery with diagnosis of SCCHN acceptable 2. Candidate for definitive surgery or radiation based therapy. 3. Fresh frozen tumor tissue must be available for genomic analysis and must pass RNA Quality Control prior to research PET/CT #1 and/or initiating panitumumab 4. Measurable or evaluable disease 5. Eastern Cooperative Oncology Group (ECOG) 0-1 6. ≥18 years of age 7. Adequate organ function 1. neutrophil count (ANC or AGC) ≥1.5 x 109/L 2. Platelet count ≥75 x 109/L 3. Hemoglobin ≥9.0 g/dL 4. Creatinine ≤1.5x upper limit of normal (ULN) 5. Hepatic enzymes (AST, ALT)≤2.5x ULN, Total Bilirubin <1.5x ULN 6. Magnesium ≥ Lower limit of Normal (LLN) 8. Negative serum pregnancy test ≤7 days before starting panitumumab (for women of childbearing potential only) 9. Competent to comprehend, sign, and date a written informed consent form 10. Sexually active males & females of reproductive potential must agree to use adequate method of contraception during treatment & for 6 months after study drug stopped History of other malignancy within past 2 years, except: 1. Malignancy treated with curative intent and with no known active disease 2. Adequately treated non-melanomatous skin cancer or lentigo maligna with no evidence of disease 3. Adequately treated cervical carcinoma in situ with no evidence of disease 4. Prostatic intraepithelial neoplasia with no evidence of prostate cancer 2. Primary tumor of the nasopharynx (nasopharyngeal cancer), sinuses, salivary gland, or skin. (Squamous cell carcinoma arising in/near nasopharynx is eligible) 3. Prior radiotherapy in planned field if it prevents standard radiotherapy dose and field 4. Prior radiation for head & neck cancer 5. Prior anti-EGFR antibody therapy (e.g., cetuximab) or treatment with small molecule EGFR inhibitors (e.g., gefitinib, erlotinib, lapatinib) 6. Prior anti-cancer treatment with: chemotherapy, hormonal therapy, immunotherapy, experimental or approved proteins/antibodies within the past 5 years. 7. Prior systemic chemotherapy for study cancer 8. Investigational agent or therapy ≤30 days before enrollment and/or have not recovered from such side effects 9. Continued chronic use of immunosuppressive agents during the clinical trial period (e.g., methotrexate and cyclosporine), corticosteroids are allowed 10. Clinically significant cardiovascular disease (including myocardial infarction (MI), unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤6 months before enrollment 11. History of interstitial lung disease e.g., pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. Patients with CT scan findings consistent with lung scarring from chronic obstructive pulmonary disease (COPD) or previous infection are eligible 12. History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results 13. Unwilling or unable to comply with study requirements 14. Pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment 15. Known positive test(s) for HIV infection 16. Major surgery within 2 weeks of enrollment. Staging endoscopy with biopsy/tonsillectomy for head & neck cancer, tracheostomy, and/or gastrostomy tube placement eligible one day after procedure. May consent to tissue collection biopsy pre-endoscopy/minor surgery and then begin protocol therapy one day after procedure. 17. Known allergy/hypersensitivity to any component of the study treatment(s) 18. Infection requiring intravenous antibiotics for any uncontrolled infection ≤14 days prior to enrollment 19. Subjects on anticoagulant therapy. Aspirin and other anti-platelet agents will not be defined as anticoagulant therapy for 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): 30.0-70.0, Diabetes Mellitus Patients with coronary artery disease and who had no glucose metabolism disorders were included to study Patients who had previous GMDs, malignancies, chronic liver and kidney diseases, rheumatologic disorders, and a BMI higher than 35 kg/m2 were excluded from the 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): 18.0-999.0, Cardiovascular Disease Patients must meet the for the trial, and be consented to take part in the PESCA sub-study. Individuals are eligible for if all of the following are satisfied: Adults (≥ 18 years) The participant is able to give informed consent. Established atherothrombotic cardiovascular disease (CVD) or high cardiovascular risk, defined as History of coronary heart disease (myocardial infarction, stable or unstable angina pectoris, or coronary revascularisation procedure), or History of ischaemic cerebrovascular disease (ischaemic stroke or transient ischaemic attack), or History of peripheral vascular disease (peripheral revascularisation procedure or amputation due to vascular disease), or For individuals without established cardiovascular disease, a calculated 5 year CVD risk of 15% or greater (calculated using the 1991 Anderson Framingham risk equation with adjustments as defined by the New Zealand Guidelines Group recommendations) The trial Investigator considers that each of the polypill components are indicated at the doses in the Red Heart Pill The trial Investigator is unsure as to whether a polypill-based strategy or usual care is better Individuals will NOT be eligible if one or more of the following are satisfied Contraindication to any of the components of the polypill (e.g. known intolerance to aspirin, statins, or ACE inhibitors; pregnancy or likely to become pregnant or breastfeeding women during the treatment period) The treating doctor considers that changing a participant's cardiovascular medications would put the participant at risk (e.g. symptomatic heart failure, high dose β-blocker required to manage angina or for rate control in atrial fibrillation, accelerated hypertension, severe renal insufficiency, a history of severe resistant hypertension). Other potential reasons for Known situation where medication regimen might be altered for a significant length of time, e.g. current acute cardiovascular event, planned coronary bypass graft operation Unlikely to complete the trial (e.g. life-threatening condition other than cardiovascular disease) or adhere to the trial procedures or attend study visits (e.g. major psychiatric condition, 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): 19.0-80.0, Coronary Artery Disease Males or females ≥ 19 years and ≤ 80 years old undergoing isolated CABG 2. Females of child-bearing age must have a negative pregnancy test at enrollment Patients undergoing combined valve or aortic surgeries 2. Patients requiring oral anticoagulant therapy on discharge that cannot be stopped (e.g. atrial fibrillation with CHADS2 score ≥ 2, pulmonary embolism, deep venous thrombosis) 3. Known allergy or intolerance to aspirin, clopidogrel or ticagrelor 4. Patients with active bleeding or history of bleeding diathesis 5. Patients with previous intracranial hemorrhage at any time, or ischemic stroke within 14 days 6. Patients with severe liver disease (e.g. ascites or signs of coagulopathy) 7. Patients with pre-operative or persistent post-operative Type 2 second-degree AV block, or 3rd degree AV block, without a permanent pacemaker 8. Patients with end-stage renal failure requiring dialysis 9. For patients enrolled in the CT angiography substudy, renal dysfunction with eGFR < 50 ml/min is an | 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, Heart Failure Congestive Heart Failure Age 18 or above, and of legal age to give informed consent specific to national laws Willing and capable of providing informed consent Capable of participating in all testing associated with this clinical investigation Stable symptomatic heart failure NYHA class II-III Left ventricular (LV) ejection fraction equal or smaller than 35 % Left ventricular end diastolic diameter (LVEDD) of 5.5 cm or greater Prescribed to optimal pharmacologic therapy QRS larger than 130 ms Patients who have been hospitalized for heart failure and who required the use of HF IV therapy within 30 days before enrollment Patients unable to tolerate anesthesia required for implant Patients with unstable angina, myocardial infarction, PTCA, coronary artery bypass graft, cerebral vascular accident, or transient ischemic attack within previous 90 days before enrollment Patients whose primary cause of heart failure is mitral or aortic valve disease, with a severe classification Patients with persistent or permanent atrial fibrillation within 90 days prior to enrollment Pacemaker indicated patients Patients whose heart failure is due to congenital heart disease Patients who have started treatment for sleep apnea or sleep disordered breathing with therapies to maintain airway patency (e.g., CPAP, Bi-PAP,APAP) with or without oxygen supplementation within the previous 6 months prior to enrollment Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis) | 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 The subject is is greater than or equal to 18 years of age The subjects has highly suspected or established carotid artery disease The subject has undergone or been referred for either unilateral or bilateral intra-arterial X-ray carotid angiography for the determination of subject management (within 30 days before or after the U/S procedure) The subject has non-diagnostic U/S of the carotids as defined by institutional standards The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month or where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study The subject has a history of acute occlusion requiring medical intervention of any artery (including aorta) within 6 months of consent The subject has a known or suspected hypersensitivity to any of the components of Optison, blood, blood products, or albumin The subject has right to left, bi-directional or transient right to left cardiac shunts | 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): 50.0-79.0, Chronic Obstructive Pulmonary Disease age 50-79 years at time of enrollment ever smokers (10 or more pack-years) participation in MESA or EMCAP studies clinical cardiovascular disease (left congestive heart failure (CHF), valve disease, coronary artery disease (CAD), stroke, or congenital heart disease) asthma, pulmonary embolism or lung disease other than COPD weight > 300 lbs chronic renal insufficiency ([estimated glomerular filtration rate (eGFR)] < 45 mL/min/1.73 m2) cancer atrial fibrillation, and contraindications to magnetic resonance imagine (MRI), gadolinium, albuterol or spirometry testing | 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 Artery Disease Stroke Patient is at least 18 years old; 2. Patient is willing and capable of complying with the study protocol requirements, including the specified follow-up period; 3. Patient is willing to provide written informed consent prior to enrollment in the study; 4. Male, infertile female, or non-lactating female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7-days prior to study procedure; 5. Patient is either symptomatic, i.e. with a history of TIAs or non-disabling stroke within 6 months of the procedure, with carotid stenosis ≥ 50%, or asymptomatic with carotid stenosis ≥ 80%, as diagnosed by angiography using methodology;4 6. The target lesion is located in the internal carotid artery (ICA) and the reference vessel diameter, i.e. the common carotid artery (CCA) is < 10 mm based on angiographic assessment Acute evolving or recent stroke within 7 days of study evaluation; 2. Cardiac embolism; 3. Acute myocardial infarction less than 72 hours prior to the procedure; 4. Major surgical procedure within 30 days preceding CAS; 5. Major surgical procedure within 30 days after the index procedure; 6. Prior major ipsilateral stroke with residual deficit or other neurologic conditions that may affect neurological assessments; 7. Pregnancy or breastfeeding; 8. Severe chronic renal insufficiency (serum creatinine is ≥ 2.5 mg/dL); 9. Contraindication to study medications, including antiplatelet therapy; 10. Prior sensitivity to contrast media that cannot adequately be controlled with pre-medication; 11. Untreatable bleeding diathesis or hypercoagulable state or refusal to blood transfusions; 12. History of uncontrolled pulmonary hypertension; 13. Intracranial pathology; 14. Patient unable or unwilling to undergo DW-MRI of the brain 15. Patient without adequate transtemporal window for transcranial Doppler examination 16. Other anatomic or co-morbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results. 17. Isolated ipsilateral hemisphere leading to subject intolerance to flow reversal; 18. Anatomic conditions that preclude performance of carotid artery stenting | 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): 21.0-999.0, Atherosclerosis for Group A Adult subjects age greater than or equal to 21 years Able to give written informed consent Prior clinical ultrasound exam showing a carotid stenosis of greater than or equal to 50 percent for Group B Adult subjects age greater than or equal to 21 years Able to give written informed consent Prior clinical ultrasound exam showing a carotid stenosis suspected of causing symptoms and/or clinical recommendation to undergo carotid endarterectomy Atrial fibrillation or other irregular rhythm that would preclude adequate image acquisition Subjects with a contraindication for the ultrasound contrast agent Subjects with pacemakers, defibrillators, cerebral aneurysm clips, neural stimulators, ear implants or other clinical contra-indications for magnetic resonance scanning will be excluded from the MRI portion of the study Subjects with an estimated glomerular filtration rate [eGFR] less than 30 ml/min/1.73 m(2) body surface area will be excluded from the contrast MRI portion of the study but will still undergo non-contrast imaging The eGFR will be used to estimate renal function if reported by the laboratory. Otherwise, estimated glomerular filtration rate (eGFR) can be based on the Modification of Diet in Renal Disease (MDRD) study equation (see below) in subjects with stable renal function. This formula is not applicable to subjects with acute renal insufficiency: eGFR (ml/min/1.73 m(2)) equal to 175 times (serum creatinine)-1.154 times (age)-0.203 times 0.742 (if the subject is female) times 1.212 (if the subject is black) Pregnant or lactating women | 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, Breast Cancer Ovarian Cancer Patients must have breast and/or epithelial ovarian cancer, primary peritoneal cancer, and/or fallopian tube cancer histologically or cytologically confirmed at the NCI that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective. All patients in cohort 1 must have measurable and/or evaluable disease. Patients in the expansion cohort 2 must have safely biopsible disease as determine by an interventional radiologist and must agree to the first mandatory biopsy (the other two biopsies optional). Breast cancer patients with locally advanced, unresectable disease must have been previously treated with standard therapy. There is no limit on number of prior therapy. Patients must be at least 6 months from their last platinum exposure. Platinum-resistant patients may participate. Patients with allergic reaction to platinums (up to and including grade 3 without a reaction protocol, and up to and including grade 2 in the face of pretrement, but not graduated treatment exposure) are still eligible. Age greater than or equal to 18 years. ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%). Life expectancy greater than 3 months. Patients must have normal organ and marrow function as defined below hemoglobin greater than or equal to 10g/dL leukocytesgreater than or equal to 3,000/mcL absolute neutrophil count greater than or equal to 1,500/mcL platelets greater than or equal to 100,000/mcL total bilirubin less than or equal to upper limit of normal (ULN) in the absence of Gilbert s syndrome AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X ULN creatinine clearance greater than or equal to 60 mL/min by 24-hour urine OR serum creatinine less than or equal to 1.5 mg/dl corrected or Ionized Calcium less than or equal to ULN Magnesium levels will be monitored and replaced as clinically indicated. Ability to understand and the willingness to sign a written informed consent document. Female patients with reproductive potential must have a negative urine or serum pregnancy test within 4 days prior to the start of the study Patients who have had chemotherapy, biological therapy, hormonal therapy (with the exception of raloxifene or others approved for bone health) or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. Patients may not be receiving any other investigational agents or had them in the previous 28 days. Patients with known brain metastases diagnosed within 1 year should be excluded from this clinical trail because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurologic and other adverse events. ---Patients with brain metastases diagnosed greater than 1 year prior to study entry are eligible if they received sterilizing therapy to the CNS (resection or radiation) and have been CNS recurrence-free for a full 1-year period. Clinically significant bleeding. Inability to swallow pills. 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 and breast-feeding women. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AZD2281. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy such as carboplatin. Previous treatment with PARP inhibitor. Major surgery within the past 28 days. Patients with locally advanced breast tumors presenting for their initial therapy, or patients with local (only in breast or chest wall) recurrence only will not be eligible for this trial For subjects in the dose-expansion cohorts, history of prior invasive malignancies within the past 5 years (with the exception of non-melanomatous skin cancers, non-invasive bladder cancer, stage I endometrial cancer or cervical cancer cured by surgical resection). Patients with a history of grade 4 allergic reaction to platinums | 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 Vascular Diseases Heart Failure Ventricular Dysfunction Fulfillment of at least one of the following ankle-brachial-index (ABI) <= 0.9, or stenosis of > 30% of the internal carotid artery, or symptoms typical for claudication and corresponding stenotic findings on the ultrasound examination age less than 18 years severly impaired communication capabilities | 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, Brain Lesion (General) Males and Females between Age 18 and 80 years Patient with current diagnosis of Diffuse Brain Lesions with cognitive and/or functional impairment MRI not showing gross atrophy or any other pathology of brain Up to date on all age and gender appropriate cancer screening per American Cancer Society Contraindication for MRI General medical contraindications for minor surgery or angiography Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study Life expectancy < 6 months due to concomitant illnesses Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study Active infectious disease. Patients known to have tested positive will have an expert consulted as to patient based on the patient's infectious status Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results Patients on chronic immunosuppressive transplant therapy Systolic blood pressure (supine) ≤90 mmHg Resting heart rate > 100 bpm | 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, Carotid Artery Stenosis Aortic Calcification Group A patients, age 40-99 years, that had a CT scan for any indication Group B - patients with severe carotid artery stenosis, that indicated for treatment Group A age <40 years Group B carotid artery stenosis, without intention-to-treat | 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): 18.0-85.0, Coronary Artery Disease Congestive Heart Failure Valvular Heart Disease Atrial Fibrillation Hypertension Pyelonephritis Acute Renal Failure Renal Failure Viral Hepatitis Alcoholic Hepatitis Steatohepatitis Cirrhosis Asthma COPD Bronchitis Emphysema Pneumonia Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis Diverticulitis Peptic Ulcer Disease Irritable Bowel Syndrome Cholecystitis Pancreatitis Malabsorption Disorders Celiac Sprue Diabetes Five Diagnosis Group: 1. Sex: Male or Female 2. Age range: 18 to 85 3. Qualifying medical diagnoses (5 diagnosis groups) For potential subjects presenting with one of the five qualifying diagnoses, the patient presents with confirmed active medical diagnoses affecting the following systems or organs Cardiovascular system: coronary artery disease, left sided congestive heart failure with EF <50%, valvular heart disease, atrial fibrillation, and hypertension Kidney: pyelonephritis, acute renal failure, or chronic renal failure stages II-V Liver: viral hepatitis, alcoholic hepatitis, steatohepatitis, or cirrhosis Pulmonary system: asthma, COPD, bronchitis, emphysema, or pneumonia Gastrointestinal/Endocrine: inflammatory bowel disease (including Crohn's disease, ulcerative colitis, or diverticulitis), peptic ulcer disease, IBS, cholecystitis, pancreatitis, or malabsorption disorders (including Celiac Sprue); diabetes (Type 1 and Type 2) 4. The patient or legal representative is able to understand and provide signed consent for the procedure. 5. Every effort will be given to balance subjects by gender, age, and race. At least 60 subjects from each of the 5 diagnostic groups and the 1 control group will be recruited. Control Group: 1. Sex: Male or Female 2. Age range: 18 to 85 3. Freedom from qualifying medical diagnoses (control group) For potential subjects for the control group, the subject is free from active medical diagnoses affecting the following systems or organs Cardiovascular system: coronary artery disease, left sided congestive heart failure with EF <50%, valvular heart disease, atrial fibrillation, and hypertension Kidney: pyelonephritis, acute renal failure, or chronic renal failure stages II-V Patients < 18 years in age or > 85 years in age Inability or unwillingness to provide informed consent Patients with pacemakers or another electrical device implanted somewhere in their body Pregnant women Patients currently undergoing therapy for cancer of any kind | 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): 40.0-999.0, Syncope Episode of syncope Patient has provided written informed consent for participation in the study prior to any study specific procedures Male or female Age > 40 years No cause of syncope clearly identified on clinical examination, lying and standing blood pressure measurements and standard 12 lead ECG Asthma or chronic obstructive pulmonary disease Severe coronary disease (myocardial infarction within 3 months, known coronary stenosis >70%, NYHA heart failure or angina symptoms Class III or IV) Known severe cerebrovascular disease or known significant internal carotid artery stenosis (>70%) Prolonged corrected QT interval Unablated accessory pathway Pregnancy or lactation Use of dipyridamole or any rate-limiting medication that cannot be safely discontinued Hypertrophic cardiomyopathy Cardiac transplantation Concurrent participation in another investigational study or trial | 0 |
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