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NCT01657136 | The aim of this study is to prospectively compare the effectiveness and safety of ivabradine and beta-blockers in the treatment of inappropriate sinus tachycardia. Inappropriate sinus tachycardia (IST) is a non-paroxysmal arrhythmia, characterized by a persistently high sinus heart rate (HR) and/or an exaggerated HR response to minimal exertion, and can be responsible for palpitations, asthenia, chest pain, dizziness and syncope, which can be highly invalidating. Conventional treatment of IST, targeted to symptoms control, mainly consists on β-blockers. However, these drugs are often insufficient or not well tolerated because of side effects (mostly hypotension) that usually limit the administered dose. Ivabradine, a sinus rate lowering agent currently employed in Europe in the treatment of stable angina and chronic heart failure, has recently been demonstrated to be effective and safe in the treatment of IST by a few case reports and clinical trials. A randomized clinical trial comparing ivabradine to β-blockers has not be performed yet. |
NCT01658033 | The objective of this phase II study is to evaluate efficacy and safety of avastin plus modified FOLFOX6 regimen in HER-2 negative metastatic breast cancer patients. Fifty-five patients will be enrolled into this study. Anthracyclines and taxanes are the most frequently used agents for breast cancer,both in adjuvant and in first-line metastatic settings.For the patients who do not respond or relapse early after the administration of a taxane or anthracycline regimen,it is clearly needed to explore new combinations and schedules of drugs.Oxaliplatin has shown very promising activity in MBC either in monotherapy or in combination with 5-fluorouracil(5-FU) with or without leucovorin (LV). Avastin is a target therapy with proven efficacy in the treatment of MBC. Avastin plus FOLFOX regimen showed synergetic effet and been used as the standard trial in metastatic colorectal cancer patients. Based on the above reason, we initiate this phase II study to evaluate efficacy and safety of avastin plus modified FOLFOX6 regimen in HER-2 negative metastatic breast cancer patients. |
NCT01660594 | Patients with stable chest pain presenting to general practitioners in UK are routinely referred to the chest pain clinics in the hospitals. They are assessed by clinical history including risk factors, cardiovascular exam, resting ECG, chest x-ray, and exercise ECG. CT calcium scoring (CTCS) is a technique that is very sensitive in identifying and quantifying calcified atherosclerotic plaques. Recent guidance from the National Institute of Clinical Excellence (NICE, citation 1) proposes the use of CTCS in patients with stable chest pain who have low likelihood of coronary artery disease (CAD). They recommend that patients with low likelihood (10-30%) have a CTCS and if the score is 0, they can be considered to have non-cardiac chest pain. However, there is controversy regarding relationship of absent calcification with significant CAD and its prognostic value. At our institution, we have been performing CTCS in this patient cohort since 2003. We plan to retrospectively review the usefulness in CTCS in patients with different likelihood for significant CAD, particularly in patients with absent calcium and compare with the traditional assessment. We also plan to follow-up these patients for any myocardial infarction and death from any cause. The study seeks to determine the usefulness of CT calcium scoring (CTCS) in patients presenting with non-acute chest pain to the rapid access chest pain clinic (RACPC) and compare it with the traditional assessment in predicting significant CAD and outcome with respect to non-fatal MI or death. |
NCT01675362 | This study will be conducted to evaluate the protective effects and mechanisms of antioxidants (vitamins A, C, E and Selenium), calcium channel blocker (Verapamil) and angiotensin receptor blocker (Lozartan) against shock wave induced renal injuries. The protective effect will be evaluated via estimation of the changes in renal tubular enzyme (NGAL) and detection of albumen levels in urine. The mechanisms of protection will be investigated by estimation of renal perfusion and functional changes using dynamic MRI. |
NCT01682057 | The purpose of this study is to evaluate the safety and performance of the ROX Anastomotic Coupler System (ACS) in patients with severe hypertension. |
NCT01719952 | A double-blinded randomised control trial conducted in the Department of Obstetrics and Gynaecology of a tertiary hospital, Universiti Kebangsaan Malaysia Medical Centre (UKMMC) for two years duration from January 1st, 2012 till December 31st, 2013. The aim of the study is to compare the haemodynamic and cardiovascular effects between intravenous carbetocin 100 μg and intravenous oxytocin 5 IU in women undergoing elective Lower Segment Caesarean Section (EL LSCS). Study hypothesis: A single injection of carbetocin is haemodynamically and cardiovascularly safe and has similar efficacy in comparison to a single injection of oxytocin. OUTCOME MEASURES systolic blood pressure (SBP), diastolic blood pressure (DBP), Heart Rate (HR), saturation of oxygen (SpO2) in certain time after drug injection. The presence of myocardial ischemia symptoms and side effects of both drugs, ECG changes such as ST depression and changes in T-waves. Hemoglobin and troponin-T level The need for additional oxytocin infusion and estimated blood loss The time interval between initial drug administration, type of additional oxytocic intervention that used and complication that happened. |
NCT01724567 | The purpose of the study is to make a head-to-head comparison of weight loss and interval training as methods of secondary prevention in overweight patients with ischemic heart disease. In western countries 80 % of patients with ischemic heart disease (IHD) are overweight (BMI > 25). Weight loss using a low energy diet (LED, 800 - 1000 kcal/day) has been shown to induce a considerable weight loss in obese but otherwise healthy patients and to reduce the risk of cardiovascular disease and diabetes in these subjects. Additionally, a British study using a very low energy diet (VLED, 600 kcal/day) to obtain weight loss, has shown that subject with diagnosed type 2 diabetes had their blood glucose normalized after an 8 week VLED. However, the effect of LED has never been examined in overweight patients with IHD. Several studies have shown that patients with IHD have a beneficial effect of exercise training regarding mortality and reduction in cardiovascular risk factors. A Norwegian group has shown that aerobic interval training results in the biggest increase in maximal oxygen uptake (VO2max). A high VO2max is correlated to decreased mortality in patients with IHD. In conclusion, weight loss and exercise are known strategies in preventing progression of IHD and development of type 2 diabetes in these patients, however a head-to-head comparison of the two methods has never been made and it is unknown which intervention is the most effective in improving cardiovascular risk profile. |
NCT01724996 | To determine the significance of a simple bedside clinical test (chest wall tenderness) to exclude myocardial ischemia in different demographic groups. When a patient is presenting with acute chest pain at the ER of the University Hospital of Zurich, the study physician in charge, who is acting simultaneously as one of four attending clinical physicians, is performing the physical examination according to routine clinical practice. The physical examination includes the testing of chest wall tenderness: Palpation of chest wall tenderness in lying 30° elevation of chest position. Flat index with standardized pressure where spontaneous maximum pain is reported (reproducible vs. not reproducible pain vs. no pain). Negative control (right side of chest mid-clavicle intercostal 6/7), reproducible vs. not reproducible pain vs. no pain. The same physician, who is blinded for the final diagnosis at the time of the physical examination, is also recording the patient history including the study interview using the standardized study questionnaire. |
NCT01736306 | Background: - At present, women do not have very accurate tests to inform of them of their personal risk of developing breast cancer. More information on the changes associated with both benign and cancerous breast lesions will help develop better risk information. Researchers have been looking at cells found in breast milk to study genetic changes related to breast cancer. However, most of these cell samples have been collected from white women. A new study wants to collect breast milk samples from African American women for further research. Comparing the results of genetic tests will help improve understanding of breast cancer risk in all women. Objectives: - To study genetic changes related to breast lesions, including breast cancer, in African American women. Eligibility: - African American women at least 18 years of age who are nursing a baby and who either have had or are being considered for a breast biopsy. Design: - Participants will be screened with personal health questions. - Participants will receive a box with sterile bottles for milk collection. They will collect two breast milk samples, one from each breast. They will also fill out a questionnaire about their medical history. - The box with the samples and the questionnaire will be returned to the clinical center for study. - After the box is returned, participants will be asked to provide a copy of the biopsy report for any breast biopsies they have had. |
NCT01770080 | Efficacy and safety of Euminz® (10% ethanolic solution of peppermint oil for topical use) compared to placebo in patients with episodic tension-type headache (ETTH) Prospective, multi-centre, double-blind, placebo-controlled, phase IV clinical trial;Parallel-groups design; Randomisation 1:1; First attack per patient will be evaluated for primary objectives, following attacks during study duration will be observed and documented. Study duration per patient: 10 weeks To demonstrate the efficacy of Euminz® to reduce the intensity of headache symptoms experienced by patients with episodic tension-type headache. The two primary objectives will be tested hierarchically (a-priory ordered) to avoid alpha-adjustment: First primary objective of the first headache episode is "pain-free" (0 or 1) after 2 hours measured on a six-step verbal pain rating scale (VPRS). Acute treatment (3 to 5 time topical use of Euminz®) will start immediately after assessment of a baseline pain intensity of at least moderate pain (3 on VPRS). Second primary objective of the first headache episode will be the decrease of intensity of pain measured by a visual analogue scale (VAS). The difference from measure point 0 (before first application of Euminz®) on the VAS in comparison to 15, 30, 45, 60, 90 and 120 minutes after start of treatment will be shown as area under the curve representing the pain intensity difference (PID). |
NCT01829659 | This study is being done to assess the effects of the CTP inhibitor on the function of your platelets (cells within your blood that are involved in the formation of blood clots) and to assess whether you have responded to the ticagrelor well enough to prevent the formation of blood clots within the stent or site in which angioplasty was performed. Recent studies have looked at how racial differences can affect platelet reactivity, the way blood clots. But these studies have not looked at the way different racial backgrounds can affect the way the blood forms clots. Minorities, such as African-Americans are underrepresented. Therefore, we are conducting this platelet reactivity study to better understand if there are differences in how this drug affects African-Americans from how they affect Caucasian patients undergoing percutaneous coronary intervention and receiving ticagrelor. These data will be compared to a historical control of Caucasian patients who underwent similar platelet function testing. |
NCT01838616 | This was a clinical effectiveness trial designed to compare the effectiveness, safety, and tolerability of treatment with tapentadol prolonged release with that of oxycodone/naloxone prolonged release in non-opioid pre-treated subjects with severe chronic low back pain with a neuropathic pain component. Both tapentadol and the opioid oxycodone are effective in chronic severe pain and tapentadol and oxycodone/naloxone have shown advantages in gastrointestinal tolerability versus oxycodone. Therefore, it was of high scientific interest to compare the latter 2 analgesics with respect to gastrointestinal tolerability. Tapentadol may have advantages regarding the neuropathic pain-related symptoms of low back pain due to its 2 mechanisms of action. |
NCT01847014 | SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to psychometrically validate the PAH-SYMPACT instrument. The objective is to assess the long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401 study. |
NCT01879293 | Cardiovascular disease is the most common cause of death in the world. Most of the attention in treating ischemic heart disease (IHD) is understandably directed toward treating coronary artery disease. However there are other treatable culprits in these patients. Left ventricular hypertrophy (LVH) is widespread in IHD patients, even in the absence of hypertension. It is a strong predictor of cardiovascular events and all-cause mortality. In one study, the presence of LVH was a stronger predictor of mortality than either multivessel cor-onary disease or impaired LV function. Metformin is an antihyperglycemic agent with a history of successful use in type 2 diabetes. In the UKPDS (United Kingdom Prospective Diabetes Study), metformin was associated with a 39% lower risk of myocardial infarction compared with conventional therapy. Metformin also offered dual benefits of improving vascular function and lessening ischemia in nondiabetic patients. Hence, the main aim of this study was to assess whether metformin could regress LVM in patients with IHD. The secondary aim was to assess the effect of metformin on LV volumes and endothelial function in this patient group. |
NCT01904695 | Background: Syndrome differentiation is one of the substantial characteristics in Traditional Chinese Medicine (TCM) but is still lack of scientific evidence. The inference methods of causal relationship between treatment and clinical effect under real-world study may help. Objectives: This study aims to assess the efficacy of Phlegm and Stasis Syndrome differentiation method in treating resistant hypertension and explore causal inference in the real-world study. Research design and methods: It is a multicenter, prospective, two-arm, cohort study including 200 patients with resistant hypertension (doctors' diagnosis based on the American Heart Association criteria 2008). Essential hypertension subjects, aged 18-70 years, blood pressure > 140/90 mm Hg even used to be on 3 or more medications for a month and diagnosed as Phlegm and Stasis Syndrome will be included. Thiazide diuretics and/or two more antihypertensive agents for 8 weeks, Chinese herbs (for synchronic treating phlegm and blood stasis) and nonpharmacological recommendations were initiated in the observational group and the control group received the same interventions without Chinese herbs. Outcome measures: The primary outcomes will be Systolic (SBP) and diastolic (DBP) blood pressure reductions and changes in symptoms and signs. Cardiac event and death incident will be the secondary outcomes. Possible side effects and adverse reactions arising from the treatment like diarrhea will be recorded. Discussion: This is a rigorous methodology pilot study and 200 participants is enough to calculate sample size in later formal trial. |
NCT02001545 | RE-ACT is a national, multi-centre, observational, prospective, longitudinal cohort study which will include patients hospitalized for ACS within 24 hours of symptom onset and who have a final diagnosis of ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI). This study aims to describe the short-term (at the end of the first month after index event) antithrombotic management patterns in a "real-life" setting for patients hospitalized with an acute coronary syndrome. |
NCT02011646 | Few obesity prevention programs have produced weight gain prevention effects that persist over long-term follow-up and those that have are extremely lengthy, averaging 52 hr in duration, making implementation difficult and costly. The 2010 US Preventative Services Task Force (USPSTF) recommendations for treating child & adolescent obesity state that programs should have ≥ 25 hr of comprehensive treatment including dietary, physical activity and behavioral counseling, and that programs with < 25 hr usually do not produce improvements. The implication is that, if centers cannot provide this level of service (as most cannot), it is not worth providing any kind of treatment at all. In extreme exception to this, an intensive 3-hr non-restrictive obesity prevention program involving participant-driven healthy lifestyle improvement plans designed to bring caloric intake and output into balance (Healthy Weight) has been found to significantly reduce increases in BMI and obesity onset relative to alternative interventions and assessment-only controls through 3-yr follow-up. We propose to test an extended 6-hr version of the Healthy Weight intervention in a sample of primarily low SES, minority adolescents and young adults who are overweight and report body dissatisfaction and subthreshold eating disorder symptoms, as these are prevalent risk factors for obesity. We will test the hypothesis that participants assigned to the Healthy Weight vs. control intervention will have significantly lower BMI and % body fat during follow-up. Secondary outcomes will include body dissatisfaction, depressive symptoms, and eating disorder symptoms. |
NCT02015858 | Pain evaluation remains a clinical problem. Pain Monitor allows pain evaluation using the measurement of skin conductance. Withdrawal of chest tube can be painful and the purpose of the study was to compare auto-evaluation of pain (visual analogic scale) and the index measured by the Pain Monitor. |
NCT02062424 | The objective of this study is to test the effect of substitution dietary guidelines that are specifically aimed at the prevention of ischemic heart disease (IHD) on the dietary intake in the general Danish population. 225 participants will be included in the intervention. The intervention is planned to run for six months in a real life setting. The study is a randomized, parallel dietary intervention study. Dietary intake, selected IHD biomarkers and anthropometric measurements will be measured at two visits during the intervention period as well as 6 months after the end of the intervention. The study includes a baseline visit followed by a visit where web based dietary records will be completed by the subjects and blood samples and anthropometrics will be measured. The intervention will consist of information on dietary advice due to the specific IHD dietary guideline or the current national dietary guidelines. The information will be provided to the participants via leaflets and recipes. After the baseline visit the subjects will be randomized to group A, B or C: In group A the subjects will receive dietary advice, according to the specific IHD dietary guideline, in group B the subjects will receive dietary advice according to the current national dietary guidelines and in group C the subjects will be instructed to follow their normal dietary habits. |
NCT02072694 | This study evaluates the hypothesis that a meal constituted of only glucose produces differences in the brain blood flow in people with obesity that are not observed in people without obesity. These changes, at least in part, could explain the mechanisms involved in maintenance or development of obesity. |
NCT02078921 | Previous studies have shown that interventions which modestly increase blood nitrite_ improve skeletal muscle function on exercise while sparing oxygen, and have been also shown to open up the blood flow during periods of oxygen deprivation. Inorganic nitrate in the diet is absorbed into the bloodstream, concentrated and reduced by bacteria in the mouth to nitrite, which is then absorbed into the bloodstream. . The purpose of this study is to look at the effects of oral inorganic nitrate supplementation on clinical markers of heart ischaemia and the frequency of angina. |
NCT02105220 | The goal of this study is to describe the influence of the chest wall on the respiratory system mechanics in morbidly obese patients and in patients with high intra-abdominal pressure. The effects of increasing and decreasing positive end-expiratory pressure (PEEP) on chest wall and total respiratory system mechanics, lung volumes and gas exchange will be evaluated, both during controlled and assisted mechanical ventilation. Patients will be studied, first, during the acute phase of respiratory failure, when requiring intubation and controlled mechanical ventilation. Then, patients will be evaluated again during weaning from the ventilator to assess the influence of PEEP in assisted ventilation prior to extubation. The goal of this study is to describe the influence of the chest wall on the respiratory system mechanics. Investigators want to describe how extreme obesity and Intra-Abdominal Hypertension (IAH) affect normal respiratory system behavior. The effects of increasing and decreasing positive end-expiratory pressure (PEEP) on respiratory system mechanics, lung volumes and gas exchange will be evaluated, both during controlled and assisted mechanical ventilation. Investigators will record and compare lung volumes, airway and transpulmonary pressure, gas exchange and hemodynamic changes caused by variations of PEEP. Patients will be studied, first, during the acute phase of respiratory failure, when requiring intubation and controlled mechanical ventilation. Patients will then again be evaluated during weaning from the ventilator to assess the influence of PEEP in assisted ventilation prior to extubation. |
NCT02144636 | This randomized control trial of diet with protein supplementation is being conducted to test the hypothesis that in overweight/obese subjects high protein diet may lead to weight loss and improvement in cardio-metabolic profile. |
NCT02148289 | The acute consumption of dietary nitrate has been shown to improve exercise capacity in athletes, healthy adults and subjects with peripheral vascular disease. Many COPD patients have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption, in the form of beetroot juice, might increase incremental shuttle walk test (ISWT) distance in COPD subjects. Acute consumption of dietary nitrate (as beetroot juice) has been shown to improve exercise capacity in athletes, healthy adults and subjects with peripheral vascular disease. Many COPD patients have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption might increase incremental shuttle walk test (ISWT) distance in COPD subjects compared to a matched, low-nitrate drink. This study is a randomized, double-blind placebo-controlled, crossover trial. Resting blood pressure, phlebotomy and ISWT are performed. Following completion, each subject is randomized to consume beetroot juice or placebo. 3 hours later, the same assessments are repeated by the same people. After a 7d washout, the entire protocol is repeated with the crossover beverage. |
NCT02158962 | The purpose of this study is to combine a culturally tailored and integrated Risk Reduction Intervention in the US Virgin Islands (USVI) in a clinical trial randomly assigning abused women to a 1) Healthy Relationships experimental group of three sessions of risk reduction interventions or 2) a Healthy Living comparison control group of three session of health promotion activities to determine if the combined, intervention is safe and effective in a test the following hypotheses: 1. Women in the integrated risk reduction intervention will score significantly lower on outcome measures of intimate partner abuse (IPA) and STD/HIV risk behaviors end of Session III and at 3 and 6 months than women in the control group 2. Women in the integrated risk reduction Intervention will score significantly higher on IPA safety behaviors and STI/HIV prevention behaviors at end of Session III and at 3 and 6 months than women in the control group. Several exploratory and major controlled studies on the mainland US have shown intimate partner violence (IPV) and intimate partner abuse (IPA) to be risk factors for a variety of physical, reproductive and mental health problems, including sexually transmitted infections and HIV/AIDS, many of which are areas of known health disparity for African American and Latina women. A recently completed study of African Caribbean and African American women in the US Virgin Islands revealed that nearly one third of women reported lifetime partner abuse and increased risk for sexually transmitted infections including HIV/AIDS. |
NCT02159625 | Hemodialysis (HD) patients with end stage renal disease (ESRD) experience higher rates of cardiovascular (CV) morbidity and mortality than do the general population and many populations with other chronic diseases. This exceptional risk is explained in part by known risk factors, such as diabetes, hypertension, and other uremia-related factors, including vascular calcification and stiffness, autonomic dysfunction, and a high burden of circulating inflammatory mediators. Recent studies suggest that blood pressure variability, especially intra-dialytic hypotension (IDH) is the most significant risk factor for these CV events. Studies have also shown that the use of IAB is capable of improving cardiovascular function for avoiding or minimizing the development of an orthostatic hypotensive episode (OHE) in patients with autonomic dysfunction, orthostatic hypotension (OH) in diabetes patients and children with orthostatic intolerance, and post-dialytic orthostatic hypotension (PDOH). The investigators propose a study to examine the use of an abdominal compression elastic support (ACES) to prevent the development of IDH in patients who are known to be prone to these episodes. The ultimate goal is to facilitate more effective and safer dialysis therapy. The ACES has a configuration that is similar to a back-support work belt or an inflatable abdominal band (IAB). All of these devices are wrapped around to compress the abdomen at the waist. I. Study Design: Biomedical 1. |
NCT02190123 | REWINDER is a multinational, multicentre, non-interventional, retrospective study of patients treated with an oral antiplatelet (ticagrelor, prasugrel or clopidogrel) while in hospital after an acute coronary syndrome (ACS) event, to be conducted in Belgium and Luxembourg. Primary objective is to evaluate the actual treatment persistence with oral antiplatelets (OAP) after an ACS in the clinical practice in Belgium and Luxembourg. The main secondary objectives are to describe the most frequent reasons for OAP treatment switch, discontinuation or reinitiation; to identify the decisionmakers in the OAP treatment changes and to characterize the patient profile in terms of demographics, diagnosis, management strategies, comorbidities and concomitant medications to identify any association between patient profile and treatment duration. Treatment of acute coronary syndrome (ACS) with oral antiplatelets (OAPs) is recommended for up to 12 months unless discontinuation is clinically indicated. Early discontinuation could result in an increased risk of cardiovascular death or myocardial infarction due to the patient's underlying disease. There are no robust data allowing to evaluate the treatment persistence with OAPs after ACS in the current practice in Belgium and Luxembourg at this time. It is currently unclear as to why patients discontinue, switch or reinitiate treatment and upon whose advice. A non-interventional study is needed to obtain reliable data on treatment persistence and reasons for discontinuation, switch or reinitiation of treatment. |
NCT02226510 | Thickening of the heart muscle (left ventricle) known medically as Left Ventricular Hypertrophy (LVH) is very common in patients with heart disease. This increases risk of cerebrovascular/cardiovascular event. LVH is asymptomatic and managed by the use of medication to control blood pressure, however LVH may be seen in normotensive patients where factors such as obesity and insulin resistance are present. Insulin resistance is a condition where although the body produces insulin it is unable to utilize it effectively. Metformin, a drug used to treat diabetes, can reduce insulin resistance and cause weight loss, it may therefore improve LVH. This study will investigate the ability of metformin to reduce LVH in patients with heart disease, this may be a novel way forward in the risk reduction of cerebrovascular/cardiovascular events. Participants will be identified throughout NHS Tayside, those eligible will be randomly allocated to either metformin or a dummy medication (placebo) and will receive one year of treatment. At the beginning of the study, the thickness of the heart muscle will be measured by ultrasound scan and cardiac Magnetic Resonance Imaging (cMRI). We will also perform non-invasive tests to measure blood vessel function. These tests will be repeated after one year. At the end of the study, we will investigate the difference between placebo treatment and metformin treatment. This study is funded by the British Heart Foundation. |
NCT02232607 | The aim of this study was to explore whether lacidipine at doses of 2 mg, 4 mg and 6 mg decreased the symptoms of angina, compared to placebo in patients with chronic stable angina |
NCT02271568 | The purpose of this study is to determine the change in kidney function and blood pressure after gastric bypass versus conventional medical therapy in morbid obesity. The study mainly focus on glomerular filtration rate(GFR) with known relation to the renal function and 24 hours ambulatory blood pressure monitoring after intervention of gastric bypass or medical treatment. Metabolic syndrome is strongly associated with obesity and the patients with this syndrome are at increased risk for cardiovascular disease. Obesity constitutes a strong risk factor for the development of chronic kidney disease. Among diabetics, obesity is known to amplify the risk for kidney disease. Bariatric surgery has yielded dramatic results including longitudinal loss of excess body weight and either complete reversal or significant improvement of several features of metabolic syndrome. In addition, many observational studies have demonstrated significant reduction in proteinuria after bariatric surgery. However, the changes in the component of cardiovascular problem among metabolic syndrome and changes in renal filtration function or progression to end stage kidney disease in morbidly obese patients after weight loss surgery have not been extensively studied. Therefore, our study mainly focus on glomerular filtration rate(GFR) with known relation to the renal function and 24 hours ambulatory blood pressure monitoring after intervention of gastric bypass or medical treatment. |
NCT02272920 | Research hypothesis: Is the treatment with renal denervation (RDN) early post ACS safe and effective and does it leads to improved cardiac function and attenuation of pathologic left ventricular remodelling? In a following study, the hypothesis will be tested in a larger ACS population with major adverse cardiovascular events (MACE) after ACS as the endpoint. Rationale for conducting this study: ACS i.e. ST-elevation myocardial infarction (STEMI) and non- ST-elevation myocardial infarction (non-STEMI) are the most important causes of morbidity and mortality in western societies. Hypertension is a major risk factor for development of ACS and heart failure but it also worsens the prognosis in patients after ACS. Our research highlights the combination therapy of PCI and RDN in an ACS patient population with simultaneous hypertension. Primary objective: The primary objective of this study is to establish safety and efficacy of combined treatment with PCI and renal denervation (RDN) in hypertensive patients with acute coronary syndromes (STEMI and non-STEMI ) having ventricular mass after 4 months as the primary variable. Endpoints: The primary end point is change in left ventricular mass (LVM) at 4 months evaluated by magnetic resonance imaging (MRI). Secondary endpoints:, blood pressure (office and 24-h ABPM), and left ventricular volumes and ejection fraction. The sympathetic nervous system plays a crucial role in the development and progression of hypertension and its adverse consequences. |
NCT02319161 | The investigators aimed to investigate the efficacy of calcium channel blockers and beta blockers for controlling tourniquet induced blood pressure increase in patients undergoing carpal tunnel operations with IVRA. For this purpose files of patients undergoing operation under IVRA were retrospectively examined in terms of demographical and hemodynamic variables. After approval of the University Research Ethics Committee, the files of patients who have been operated under intravenous regional anesthesia (IVRA) in orthopedics clinics between January 2009 and January 2010 were retrospectively investigated. A total of 312 patients, 164 patients with carpal tunnel syndrome and 148 patients with trigger finger have been operated under IVRA. Out of 164 patients who have been operated due to carpal tunnel syndrome, 50 patients in which either calcium channel blockers or beta blockers were used for treatment of critical blood pressure increase after tourniquet inflation and in which whole data were obtained, were included to the study.The patients with systolic blood pressure above to 150 mmHg following tourniquet inflation and in which bolus dose of diltiazem 10 mg (Group I) or calcium channel blocker 0.5mg/kg (Group II) have been administered by intravenous route constituted the study groups. Demographical characteristics and hemodynamic parameters were recorded from the patient files. |
NCT02347111 | In this pilot and feasibility study, the investigators will enroll patients with frequent symptomatic episodes of atrial fibrillation (AF) in a cross-over study testing two different classes of anti arrhythmic drugs (AADs). This pilot and feasibility study will provide preliminary data for a larger study in which the investigators will test the hypothesis that a common AF genetic risk allele modulates response to different AADs. 1.0 Background While atrial fibrillation (AF) is the most common sustained cardiac arrhythmia requiring therapy, it is also associated with increased risk of stroke, heart failure, myocardial infarction, dementia, and death. The number of Americans affected with AF is expected to surge to nearly 16 million by the year 2050. The AF epidemic may in part be related to the aging of the population and increasing prevalence of recently identified risk factors including obesity, metabolic syndrome, obstructive sleep apnea, and inflammation. Furthermore, there is increasing support for the idea that both common and rare genetic variants also increase susceptibility to AF which can clinically manifest in the presence of acquired risk factors. While clinical risk factors for AF are established, the genetic components of this "multiple-hit" genetic model for the development of AF have only recently been identified. Despite recent advances in catheter-based and surgical therapies, anti-arrhythmic drugs (AADs) remain the mainstay of treatment for patients with symptomatic AF. |
NCT02357212 | The aim of this research is to evaluate the effect of early invasive therapy and appropriate revascularization compared with conservative management and selective revascularization among women with an acute coronary syndrome. This study aims to enroll 1,000 women who present with AcuteCoronarySyndorme ( ACS). Patients will be identified through screening of all women admitted for chest pain, and those women with positive cardiac enzymes after operative procedures. After receiving permission to approach the potential subjects, trained and delegated study personnel will present the study to the patient. The informed consent process will be completed by the study coordinator, PI or co-investigator. The patient will have all procedures, risks and benefits explained and offered time to read and review the informed consent form. They will be given adequate time to ask questions, consult with family members or primary physicians. Specifically, written informed consent will be obtained in the emergency department or in the cardiology ward/unit before the patient is sedated/in the catheterization laboratory. . When a patient consents to participate in the study, their treatment assignment will be randomly determined by opening a sealed envelope that contains one of two treatment strategies. The blinding envelopes will be created by the Biostatistics group and will be sealed. Once informed written consent is obtained (see accompanying flow chart), each patient will be randomly assigned to early invasive therapy versus conservative management. All patients will be administered aspirin 325 mg, clopidogrel 600 mg, and atorvastatin 80 mg. Anti-thrombin therapy (unfractionated heparin or bivalirudin according to physician discretion) will be administered intravenously. |
NCT02381340 | Obesity and its associated conditions have reached epidemic proportions. Estimates are that about one third of the adults in the United States have obesity. At this moment there are many therapeutic approaches for the treatment of obesity. But, efficacy of most treatment options are limited and so far surgical intervention has been proven to be the only strategy to overcome severe obesity. However, bariatric surgery has limitations and risks, which might be minimized by non-incisional endoscopic procedures. BaroSense developed a new device, called the Articulating Circular Endoscopic (ACETM) Stapler, which can be used in the treatment of obesity. It is a trans-oral procedure, which intends to reduce the ability of the stomach to expand by creating plications in the region of the fundus and greater curvature. In contrast with other bariatric surgery it is endoscopically performed, reversible and if it fails most future surgical options are still open. The main study ('Open, prospective study to evaluate the safety and preliminary effectiveness of the BaroSense ACE™ Stapler for the treatment of obesity', multicenter study (MUMC+, AMC and St. Antonius), accepted by MEC AMC) seeks to determine the safety and efficacy of this plicating system for patients with severe obesity. In this sub-study we want to unravel the exact mechanism and provide more information about the efficacy of the BaroSense ACE™ Stapler. Therefore we will measure changes in various parameters that are known to affect weight loss and metabolism, before and after gastric plication (by using the BaroSense ACE™ Stapler) in overweight subjects (these parameters will only be measured in patients at MUMC+). |
NCT02390323 | This study is intended to evaluate a monitor that will facilitate ascertainment of an effective sympathetic blockade following Lumbar Sympathetic blocks. Utilization of a monitor with a rapid response and easy clinical applicability which can demonstrate effective sympathetic block would increase efficiency within the procedure suite and also serve to function as an objective endpoint for the evaluation of sympathetic blockade in future research.In current clinical practice, the most commonly used monitoring methods are clinical observations of sympathetic blockade, skin temperature monitoring, pulse pressure monitoring and any combination of these monitoring methods. The skin temperature and pulse pressure may increase after sympathetic block. However, changes in the skin temperature and pulse pressure often demonstrate an unpredictable or delayed response. Confounding variables, such as ambient temperature, coexisting vascular disease, use of other vasoactive medications may contribute to inconsistencies in the temperature or pulse pressure responses. Normal sympathetic activity stimulates muscarinic receptors in the periphery that subsequently stimulate the sweat glands to secrete and fill with sweat containing sodium and other electrolytes. The electrolytes present in the sweat increase the electrical conductance while decreasing the electrical resistance at the skin level. The real-time changes in skin conductance indices can be monitored at the skin level, by use of non-invasive electrodes attached to the skin (similar to EKG electrodes). A computer program analyzes the data and produces a real-time graphic and numeric data demonstrating the skin conductance response. |
NCT02408263 | Pain has been defined as a subjective experience. Various pain assessment tools, (such as NRS) have been developed and validated to objectively monitor and treat pain. There are certain patient populations, in whom, the current pain assessment tools cannot be used effectively due to communication problems such as cognitively impaired patients. In the US, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has made it mandatory to monitor and treat pain. In the absence of reliable pain assessment tools that would objectively measure pain, there is also risk of under treatment and overtreatment of pain that may lead to negative outcomes. Therefore, a monitor that is able to predict pain levels objectively, will help to achieve above goals. The investigators are using Skin Conductance Algesimeter (SCA) to measure pain by analyzing changes in skin conductance. |
NCT02472938 | This is a phase IV, interventional, multicenter, randomized, double blind, placebo-controlled, 24 week study to assess the MRI onset of efficacy of BG00012 240 mg BID in newly diagnosed naïve-to-treatmentRRMS patients. The study will enroll 150 patients in 20 centers in Italy. Patients will be randomized in a 2:1 ratio to receive either BG00012 240 mg BID or placebo for 24weeks. The primary objective of the study is to assess the early efficacy of treatment with BG00012 240 mg BID in the brain of newly diagnosed and naive-to-treatment patients with RRMS. Secondarily, the time course of this beneficial effect will be assessed and the safety of BG00012 will be evaluated. BG00012, a new oral formulation of dimethyl fumarate, has been recently approved by Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS). Its mechanism of action appears to be mediated, at least in part, through activation of the nuclear factor (erythroid-derived 2)-related factor 2 (Nrf2) antioxidant response pathway, a critical cellular defense mechanism for mitigating oxidative, inflammatory, and xenobiotic stress. Inflammation in relapsing MS is indicated by the infiltration of immune cells into the CNS and consequent damage to the blood-brain barrier that can be visualized on gadolinium-enhanced MRI. BG00012 has shown to produce a significant beneficial effect on clinical as well as MRI efficacy parameters in RRMS in two pivotal Phase III trials, namely DEFINE and CONFIRM. |
NCT02507050 | The aim of the study is to test whether, in patients with angina and flow limiting epicardial coronary artery disease, pre-treatment with Ivabradine, as opposed to beta blockers, will reduce post percutaneous coronary intervention induced microvascular dysfunction. We will be recruiting patients with stable angina referred for percutaneous intervention (PCI) due to flow limiting coronary artery disease. All patients will be on an existing beta blocker prescription (standard first line angina therapy). Our hypothesis is that Ivabradine will attenuate microvascular dysfunction post PCI when compared to standard beta-blocker pre-treatment. We intend to test this in a randomised, open-label parallel arm study with a direct comparison between Ivabradine and beta-blockers (standard therapy). Patients will be randomised to receive either Ivabradine (and stop beta blockers) or continue beta blockers for 6 weeks prior to the PCI procedure. The primary endpoint will be IMR (index of microvascular resistance) post PCI, as a marker of microvascular dysfunction and procedural related myocardial injury. IMR is a potent marker of adverse outcome in STEMI patients and in ACS after PCI. Although this has yet to be assessed in the elective setting, a reduction in IMR with Ivabradine may indicate a potential to improve outcomes and lessen iatrogenic microvascular dysfunction post PCI. IMR is assessed using thermodilution catheters placed distal to the coronary stenosis and by producing hyperaemia. To assess the medium term effects on the microcirculation post PCI all patients will have a stress perfusion cardiac MRI 12 weeks post procedure. |
NCT02516839 | The objective of this proposed study is to collect initial efficacy data on ROC and ROC + BWL compared to an attentional control (AC) and to BWL. The investigators have developed a new model for the treatment of obesity, called Regulation of Cues (ROC), which is based on Schachter's Externality Theory. The ROC program targets two theorized mechanisms for overeating in Schachter's Theory; decreased sensitivity to appetitive cues and increased sensitivity to external food cues. Considering that BWL has merit for some people, but fails to facilitate maintenance, this study will compare ROC, BWL, ROC+BWL combined and an attentional control (AC). The investigators will recruit overweight/obese adults and will assess them at baseline, mid-treatment (month 6), post-treatment (month 12), mid-follow-up (month 18) and follow-up (month 24). Assessments will include body mass index (BMI), body composition, and binge eating over the course of treatment and follow-up. This study will contribute to the study of basic behavioral mechanisms and food intake, could provide a novel model for the treatment of obesity, and could inform clinical decision making regarding obesity treatment. |
NCT02532699 | This the first report undertaken to assess the effect of supplementation with oral gamma-aminobutyric acid (GABA), adenosine and antrosterol-containing AC mycelia on blood pressure among people with mild hypertension. Overall, AC mycelia consumption for 8 weeks could successfully reduce mean diastolic and systolic BP through the suppression of PRA that is linked to downstream suppresion of angiotensin II formation, which further decreases the sympathetic outflow that leads to hypertension. In addition to blood pressure lowering properties, AC mycelia also has beneficial effect in reducing oxidative stress, significantly. No adverse events were noted, suggesting that AC mycelia deserve its consideration as a candidate for safe alternative treatment to conventional anti-hypertensive medications. This the first report undertaken to assess the effect of supplementation with oral gamma-aminobutyric acid (GABA), adenosine and antrosterol-containing AC mycelia on blood pressure among people with mild hypertension. Forty-one subjects with systolic blood pressure (SBP) between 130 and 179 mm Hg and/or diastolic blood pressure (DBP) between 85 and 109 mm Hg were randomized to receive either AC mycelia or starch placebo for 8 weeks, and had follow-up observation for an additional 2 weeks. SBP in the subjects given GABA, adenosine and antrosterol-rich AC mycelia significantly decreased compared to those who received the placebo (p<0.05). DBP also decreased after the intake of AC mycelia. Compared to the placebo, AC mycelia significantly reduced plasma renin activity by a maximum of 25 % and 36 % on week 8. |
NCT02608255 | A Single-center prospective pilot study enrolling chest pain patients. CD 26 measurement will be performed and compared to troponin µs for early triage of these patients. This novel biomarker of myocardial ischemia (CD26) will be measured at the time of first medical contact (T0) and after 30 min simultaneously o troponin Ic. All patients aged over 18 years with chest pain which may be related to acute coronary syndrome requiring pre hospital medical contact through the Emergency Medical Service. First objectives: demonstrating the early positivity of CD26 compared to ultra-sensitive troponin. |
NCT02626741 | The purpose of this study is to determine whether meal replacement, SlimWell ®, is effective in the treatment of obesity patients with metabolic syndrome. The participants are divided into two groups: intervention group and control group. In the intervention group, the participants receive a meal replacement plus life style modification. In the control group, the participants receive only life style modification. Sample size calculation is 69 participants per group. Primary outcome is to compare the weight loss between the intervention group and control group. |
NCT00043277 | The goals of this study are: 1. To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis; 2. To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis; 3. To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH). The goals of this study are: 1. To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis; 2. To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis; 3. To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH). |
NCT00102037 | This trial is conducted in the United States of America (USA). The purpose of this clinical research trial is to understand how safe and effective Recombinant Activated FVII is for reducing bleeding and blood transfusions in patients undergoing spinal fusion surgery. |
NCT00154674 | Hypothermic resuscitation is proven to be benefit to the cardiac origin cardiac arrest patients for it improve brain recovery dramatically. However, traditional cooling devices and methods, most external cooling methods, include ice blanket, cooling helmet, or ice packing lower the body temperature slowly or inefficiently which make many emergency physicians hesitate to perform hypothermic resuscitation. To improve and promote the practice of hypothermia resuscitation, more efficient temperature control method is necessary. We conduct this clinical trial to evaluate the safety and feasibility of internal cooling catheter and temperature regulatory device, which is approved by FDA in neurologic ICU for temperature control, in the cardiac arrest patients. We recruited successful resuscitated nontraumatic cardiac arrest adult patients in the emergency department to evaluate the safety and feasibility of application those invasive internal temperature regulator devices. Internal cooling catheter, "ICY" , and thermal regulator device, "Coolguard 2000" are applied to the patients from femoral vein. WE definite 4 stages according to the temperature during the clinical trial: "The Cooling Phase", "Hypothermia phase", "Rewarming phase", and "Postrewarming phase". The temperature is lowed or elevated by the rate 0.5C/hr during the Cooling and Rewarming Phase, and it is maintained 33 +/- 1 C during hypothermia phase for 12 hours according to the comment of ACLS. To understand the safety and feasibility, regular blood sampling, bedside EEG and vital monitors, and special sheets are designed to document the every reasons, time points or every clinical events during hypothermia therapy. |
NCT00171054 | The purpose of this study is compare treatment with valsartan with the possible addition of a diuretic, hydrochlorothiazide, on high blood pressure with the drug amlodipine with the possible addition of a diuretic, hydrochlorothiazide. In particular, the effect of treatment on the stiffness of the blood vessels will be studied. |
NCT00314002 | Official Title: Compassionate Use of Catheter Thrombectomy (Aspirex 11F) in Patients With Massive Pulmonary Embolism Study Population: Patients >/= 18 years of age with massive pulmonary embolism suitable for mechanical thrombectomy with Aspirex 11F. Treatment: Aspirex 11F assisted thrombectomy _________ The study was terminated early. After having treated seven (7) patients, it was decided in April 2007 that the handling characteristics of the test device should be upgraded before continuing the trial as planned. Therefore, the study was long-term interrupted and finally terminated early. This decision was made by the sponsor in full accordance with the principal investigator. Further studies shall be conducted to show effectiveness and safety of the Aspirex PE catheter thrombectomy device. _________ Primary Endpoints: 1. Thrombectomy with the Aspirex catheter device is associated with an immediate decrease in mean pulmonary artery pressure (PAP) and pulmonary vascular resistance (PVP). 2. The Aspirex thrombectomy catheter does not cause perforation/dissection to treated and untreated cardiovascular structures. Secondary Endpoints: 1. Thrombectomy with the Aspirex catheter device is associated with improved flow in the treated main and lobar pulmonary arteries as assessed by the angiographic Miller index. 2. There will be no significant mechanical haemolysis as assessed by plasma free haemoglobin levels. 3. In-hospital mortality will not exceed 20%. Study Design: A prospective international multicenter non-randomized registry assessing the safety and efficacy of the Aspirex 11F mechanical thrombectomy device. |
NCT00324233 | Intermittent catheterization is a well-known method used for emptying the bladder. The objective of this study is to compare the residual urine after intermittent catheterisation with 2 different, hydrophilic coated, intermittent catheters. The study is a randomized, single blinded, crossover study including 24 healthy males. |
NCT00392639 | According to international guidelines, mild therapeutic hypothermia is recommended for resuscitated patients after cardiac arrest due to ventricular fibrillation. Whether external or internal cooling is superior in terms of prognosis or security remains unknown. The aim of this study is to evaluate in a randomized trial the clinical and economical interests of the endovascular cooling versus the conventional external cooling for the management of hypothermia after cardiac arrest. According to international guidelines, mild therapeutic hypothermia is recommended for resuscitated patients after experiencing cardiac arrest from cardiac origin: "unconscious adult patients with spontaneous circulation after cardiac arrest should be cooled to 32-34°C for 12-24 hours when the initial rhythm was ventricular fibrillation" or pulseless ventricular tachycardia. "Such cooling may also be beneficial for other rhythm or in-hospital cardiac arrest". "External or internal cooling techniques can be used to initiate cooling within minutes to hours". The two main randomized and positive studies dealing with the efficiency of hypothermia after cardiac arrest have used external cooling systems. However, several animal studies documented the importance of initiating hypothermia as soon as possible after cardiac arrest. Intravascular cooling enables more rapid induction of hypothermia compared with external cooling method after brain injury. Although several human studies have also documented that intravascular cooling provides more precise control of core temperature than external methods and although an endovascular method has been used safely in pilot studies in those experiencing hypothermia after cardiac arrest, the superiority of such a cooling on the prognosis after cardiac arrest remains unknown, as well as its cost efficiency. |
NCT00471289 | The purpose of this study is to investigate the performance of paclitaxel-coated balloon expandable stainless steel coronary stent for the treatment of infrapopliteal stenoses and occlusions in patients with critical limb ischemia compared to percutaneous transluminal balloon angioplasty (PTA). Critical limb ischemia (CLI) is a serious condition that is becoming more and more common in the western world due to the growing percentage of elderly in the population and the rising incidence of diabetes. In about 40% of patients a stenosis or occlusion in the arteries below the level of the knee will be present. Restoration of blood flow is imperative to allow pain relief and tissue healing. Without revascularization patients with CLI are at risk for limb loss and potentially fatal complications such as sepsis. In patients treated with percutaneous transluminal balloon angioplasty (PTA)significant restenosis is found in approximately 50% after 6 months. In interventional cardiology a significant reduction in restenosis rates in coronary arteries has been found using drug eluting stents (DES), including the paclitaxel eluting stent (TAXUS, Boston Scientific). DES locally deliver drugs (e.g. paclitaxel) that interfere with the restenosis process. Using DES in treating below the knee (infrapopliteal) arterial lesions in patients with CLI may improve patency and clinical outcome. Comparison: Treatment of below the knee arterial lesions in patients with CLI with PTA and DES compared to only PTA. |
NCT00497094 | Background. Carotid artery stenting (CAS) recently has become an accepted method for treatment of patients with high-grade carotid artery stenosis, who are at an increased risk for surgical carotid endarterectomy (CEA). The reported rates of neurological complications of CAS substantially decreased during the past years, and the routine use of cerebral protection devices and low profile catheter systems have further increased the procedure´s safety. In the early 90's large surgical trials in North America and Europe (NASCET, ECST and ACAS) demonstrated superiority of CEA compared to best medical treatment for symptomatic and asymptomatic patients. Provided that the ongoing randomized controlled trials comparing CAS and CEA confirm equivalence between the these methods, CAS similar to CEA is applicable to symptomatic and asymptomatic patients with high grade carotid stenosis. However, particularly in asymptomatic patients, the indication for revascularisation remains debatable. Protected CAS is associated with a very low rate of neurological complications, which are below the AHA recommendation for treating asymptomatic patients (3%). However, the introduction of new vascular protective medications like statins and clopidogrel during the recent years substantially improved the spectrum of best medical treatment, and the findings of NASCET, ECST and ACAS with respect to best medical treatment may therefore not be applicable any more. Study hypothesis and aims. Given the low frequency of spontaneous neurological complications, the preferable therapeutic approach to patients with asymptomatic high grade ( > 80%) carotid artery stenoses is currently unknown. |
NCT00533156 | The purpose of this study is to assess the safety and feasibility of the 7F Ensure Medical Vascular Closure Devices to facilitate hemostasis in patients undergoing diagnostic or interventional coronary procedures using a standard 7F introducer sheath. Achieving hemostasis at the arterial puncture site after percutaneous cardiac catheterization is a potential cause of bleeding, hematomas, pseudoaneurysms, and various other vascular complications. Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression or the deployment of a vascular closure device. Manual compression is time consuming for the health-care provider, and painful for the patient. In addition, prolonged periods of immobilization and bed rest may be required. Vascular closure devices have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation. The Ensure Medical Vascular Closure device (VCD) is intended for femoral artery puncture site closure in patients who have undergone coronary catheterizations using a standard 7F introducer sheath. The device is comprised of a bio-absorbable plug and a plug delivery system. The plug delivery system is designed to position the bio-absorbable plug to the extravascular surface of the femoral artery access site, facilitating a hemostasis response. The Ensure Medical VCD has been studied in a prior feasibility trial of 149 patients utilizing a 6F introducer sheath, which demonstrated that: (1) the device could be used to successfully obtain rapid hemostasis and early ambulation in patients undergoing catheterization procedures; and (2) the low incidence and relatively minor nature of the observed closure related complications suggests that the device is safe for its intended purpose. |
NCT00633503 | Tissue transfer flaps are a method of moving tissue from a donor location to a recipient location. In the case of a free tissue transfer flaps, the blood vessels to the transferred tissues are detached and then re-attached to different arteries & veins at the recipient site. The process of reconstructive surgery using tissue transfer flaps allows for improved results in terms of functionality, aesthetic appearance, and psychological well-being in patients requiring reconstructive surgery after cancer resection or trauma. The process of reconstructive surgery using tissue transfer flaps is not without complications. These complications may include acute arterial or venous occlusion, as well as the development of late complications such as fat necrosis and flap atrophy. The purpose of this pilot study is to determine if a novel, unique, portable, non-contact optical imaging device developed at the Beckman Laser Institute called Modulated Imaging (MI) can detect changes in a flap's optical properties, which can correlate with arterial or venous occlusion or with the development of fat necrosis or flap atrophy. The study would also evaluate if changes in the tissue transfer flap's optical properties, as detected by the device could be employed as a monitoring device in the post-operative period after reconstructive surgery. The MI device's detection of specific optical properties of a tissue flap could also potentially be used as a diagnostic tool to predict the likelihood of the development of fat necrosis or flap atrophy in a delayed fashion several months after reconstructive surgery. |
NCT00667381 | This study is designed to evaluate the routine use of vascular ultrasound as an aid for proper placement of a femoral arterial sheath during cardiac catheterization and peripheral arterial angiography. Cardiac catheterization is conventionally performed with femoral arterial access using a combination of arterial pulse palpation, anatomical landmarks, and fluoroscopic landmarks to guide needle insertion. Vascular access complications including hematoma formation, retroperitoneal bleeding, and arterial dissection are the most common types of adverse events associated with cardiac catheterization, and have been associated with insertions above and below the level of the common femoral artery. Real-time ultrasound assistance for central venous catheter placement has been proven in multiple studies to reduce complications, and has been recommended by the Agency for Healthcare Research and Quality as a "Top 11 Highly Proven" patient safety practice. This recommendation has not yet been extended to arterial access, due to a lack of studies to date. However, ultrasound assistance is licensed for and commonly utilized for arterial access, especially in difficult patients. In a pilot study of 71 procedures performed by the lead researcher, ultrasound guidance was associated with an improved 1st pass success rate (83% vs 47%, p=0.002), reduced risk of accidental venipunctures (0% vs 25%, p=0.002), and greater overall success in common femoral artery cannulation (89% vs 69%, p=0.048) as compared with the fluoroscopic control. |
NCT00674778 | Previous randomised studies showed that radial artery catheterisation for percutaneous cardiovascular procedures has a superior safety profile than femoral access, however the confirmation of these benefits in the real world by a large, specific, observational study is still lacking. We endeavoured to assess the access site-related outcomes of any percutaneous cardiovascular procedure by designing a prospective registry monitoring a consecutive sample of patients in a short period of time at nine Roman hospitals reflecting the contemporary state of health care. |
NCT00736086 | To evaluate early ambulation in patients who receive the StarClose™ VCS post-percutaneous diagnostic procedure. To evaluate the StarClose™ VCS in the femoral artery in subjects who are ambulated early post-percutaneous cardiac or peripheral vascular, diagnostic catheterization procedure. The clinical use of vascular closure devices for rapid hemostasis after femoral access was first reported in 1991. 18 participants may be ambulated almost immediately after diagnostic coronary angiography and discharged many hours earlier than currently practiced in most centers utilizing a supine restriction period of 6 hours after diagnostic catheterization.14 After coronary interventions, participant comfort is additionally increased by immediate sheath removal. This early ambulation study is an evaluation of a clip-based technology, which achieves vascular hemostasis with the use of a novel extravascular Nitinol clip to provide an immediate mechanical closure that does not depend upon the body's clotting system. The procedures will be performed in participants who meet specific entrance criteria. |
NCT00742014 | The primary objective of this study is to examine the effects of Sildenafil, administered during cardiac catheterization, on right ventricular contractility in children with pulmonary arterial hypertension. The effectiveness of Sildenafil as a pulmonary vasodilator in children with heart disease was first reported in detail during cardiac catheterization and postoperatively in 2003. It is now used frequently for long-term treatment of children with pulmonary arterial hypertension at The Hospital for Sick Children and it is now a routine part of the hospital's testing protocol for all patients being evaluated for pulmonary hypertension in the cardiac catheterization laboratory. The beneficial effects of Sildenafil in pulmonary hypertension are thought to result predominantly from relative vasodilatory and antiproliferative effects on the pulmonary vasculature. On the basis of early data showing lack of significant PDE5 expression in the normal heart, PDE5 was thought to be expressed in the coronary vessels but not in the human myocardium. Very recently, it was reported for the first time that PDE5 is markedly upregulated in hypertrophied right ventricular myocardium in humans and that in the rat PDE5 inhibition with Sildenafil increases contractility in hypertrophied right ventricular myocardium but not in normal right ventricle, which lacks PDE5 expression. The assessment of right ventricular contractility in humans is a challenge, but we have developed several techniques that are recognized as 'state of the art' assessment of right ventricular function. The purpose of this study is to examine the effects of Sildenafil, which is routinely administered during cardiac catheterization to assess pulmonary vascular resistance, on right ventricular contractility in children with pulmonary arterial hypertension. |
NCT00827957 | Controlled therapeutic hypothermia is a method of preserving neurological function post-resuscitation.It has been associated with improved functional recovery and reduced histological deficits in animal models of cardiac arrest. Three randomized clinical studies have been reported showing improved neurological outcome and reduced mortality in post-resuscitation patients treated with hypothermia compared to controls. Of the various methods of inducing hypothermia, internal cooling using an endovascular catheter and external cooling using gel pads with a water based circulating system have shown the most promise. There have not been any studies looking at outcomes between the two methods of cooling. |
NCT00838175 | Suture-mediated closure devices are effective and safe for achieving rapid hemostasis in femoral venous access site and reducing the incidence of complications associated with traditional closure methods. Furthermore, there are predictive factors(such as sheath size, obesity, procedure duration, and anticoagulation status)that we can use to assess the procedure's likelihood of success in various patients. This is a retrospective cohort study of consecutive patients receiving suture-mediated closure of the femoral vein following catheterization. All patients undergoing cardiac or arterial catheterization by the Interventional Cardiovascular Medicine Service at The Brigham and Women's hospital from 3/1/02 to the onset of the study and who had femoral venous access during that time were considered for closure of the venous site; however, the decision to use the closure device was left to the discretion of the physician. Contraindications to using the closure device include a groin hematoma that had developed during the procedure and/or difficult access due to extensive scar tissue from surgery or multiple prior vascular accesses. All in-hospital endpoints have been collected in the pre-existing Catheterization Laboratory Database. Patient's data will be extracted from this database as indicated in the procedure below. Each patient will be reviewed for clinical follow-up and the presence of adverse events including but not limited to hematoma, thrombosis, blood loss, vascular imaging, the need for additional procedures, and re-admissions within 30 days of closure. |
NCT00843297 | Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH) lowers mortality and reduces neurologic damage after cardiac arrest. The investigators evaluated the efficacy and side effects of therapeutic hypothermia in an unselected group of patients after SCA. Consecutive patients with restoration of spontaneous circulation (ROSC) after resuscitation due to out-of-hospital SCA, admitted to our intensive care unit, underwent MIH. Hypothermia was induced by infusion of cold saline and whole-body-cooling methods (electronic randomization: invasive Coolgard or non-invasive ArcticSun). The core body temperature was operated at 32 to 34 °C over a period of 24 hours followed by active rewarming. Neurological status was evaluated at hospital discharge and 6 months after discharge using the Pittsburgh Cerebral Performance Category (CPC). Blood samples of neuron-specific enolase (NSE) were collected during 72 hours. |
NCT00846846 | In order to expand safety information in patients treated with the Endeavor Drug Eluting Stent System, or next generation model, a Continued Access (CA) study is added to the PROTECT Trial. The amended study is "PROTECT CONTINUED ACCESS" ("PROTECT CA"). This was a prospective, multicenter, non-randomized, single-arm, open-label post market surveillance study designed to expand safety information in patients treated with the Endeavor® Zotarolimus Eluting Coronary Stent System. Since their introduction, Drug Eluting Stents (DES) have markedly decreased stent restenosis and the clinical need for repeat revascularization frequently observed with bare metal stents (BMS)1-10. However, the widespread use of DES has raised concerns regarding the occurrence of late stent thrombosis (> 30 days after stent implantation)12-14. Although the incidence might seem low (0.2-0.7%)13,15-18 the high mortality and morbidity associated with stent thrombosis, and the soaring number of stents implanted annually, make it a significant medical problem. The purpose of this trial was to investigate the long-term clinical safety and efficacy of the Endeavor drug eluting stent in a large and higher risk patient population, which more closely reflects clinical practice today. Both unstable and stable patients with single or multivessel disease and complex lesions were eligible for enrollment. The selected primary endpoint was stent thrombosis, defined as definite and probable stent thrombosis according to the ARC definition, at 3 years. |
NCT00970476 | To determine if arterial stiffness as measured by non-invasive pulse wave velocity can predict the response to resynchronization therapy in heart failure. The patients receiving CRT are medically refractory, symptomatic, NYHA class III or IV disease and QRS duration of 130 m sec or greater, and a left ventricular ejection fraction of 30 percent or less. The pulse wave velocity between carotid and femoral (PWVcf) will be recorded in each subject at base line (before and after CRT), at one month (after AV delay optimization) and again at 6 months after CRT. The arterial pulse wave is recorded at a proximal artery, such as the carotid artery, and as well as at a distal artery, such as the femoral artery. The superficial location of the carotid and femoral arteries means that their pulse waveforms are readily measured noninvasively using the M Hz Doppler probe, and between these two sites the pulse wave has to travel through most of the aorta. The time delay between the arrival of a predefined part of the pulse wave, such as the foot, at these 2 points is obtained by gating to the peak of the R-wave of the ECG. The distance traveled by the pulse wave is measured over the body surface and PWV is then calculated as distance/time (m/s). Clinical evidence of response: Either one or more of the following: 1) Improvement in NYHA functional classification, 2) Improvement in 6 minute walking distance. |
NCT01001663 | Is the FemoSeal® closure device safer and more comfortable than manual compression for femoral artery access closure after coronary angiography? Access site complication after coronary angiography is still a challenge in everyday practice. The FemoSeal® closure device has proven very safe as shown in the swedish SCAAR registry. This study is aimed to investigate, in a randomized design, if the FemoSeal® has an advantage in safety and efficacy over manual compression. |
NCT01108120 | - Diabetic foot ulcers (DFU) are one of the chronic consequences of diabetes which constitute the most important cause of non-traumatic amputation of the inferior limbs. Patients with diabetes are 22 times more likely to have foot ulceration or gangrene than nondiabetics，while foot ulceration precedes 85% of lower-extremity amputation. - Three factors combine to promote tissue necrosis in diabetic feet: ischemia, neuropathy and trauma. Among them, ischemia peripheral arterial disease may play the important roles in the development of DFU. Moreover, diffuse vascular disease is the main characteristics, and thus it becomes difficult for treatment by using arterial bypass or balloon angioplasty. Therefore, we hypothesized that continuous arterial thrombolysis may be an effective therapy in diabetic foot. The purpose of this study is to investigate the effectiveness and safety of continuous intra-femoral artery injection of urokinase by micro-artery-pump in diabetic ulcers. - We select 200 diabetic patients with Wagner grade 1 ~ 3 foot ulcers. They are divided into two groups randomly: thrombolysis group and control group, 100 cases in each group. - After diabetic dietary advice, all patients receive insulin therapy to control blood glucose within a range of 5 - 10 mmol/L. Then the patients receive conventional care for their ulcers. To remove extensive callus and necrotic tissue, wound debridement was performed. Broad spectrum antibiotics are prescribed if ulcers show clinical signs of infection. |
NCT01121510 | The QuickClose Design 9 is a prospective, non randomized study, to evaluate the safety and efficacy of the QuickClose design 9 closure device. patient undergoing a diagnostic or therapeutic angiogram procedure will be treated with the QuickClose Design 9. Patients will be monitored until 30 days after the procedure. the primary safety endpoint is the incidence of major complications related to method for achieving hemostasis at the puncture site. the secondary safety endpoints is the incidence of minor complications related to method for achieving hemostasis at the puncture site. the primary efficacy endpoints are time to hemostasis, time to ambulation and time to discharge. the secondary efficacy endpoints are device and procedure success |
NCT01133119 | In the Cardiac Diagnostic and Interventional Unit (CDIU) at the Hospital for Sick Children (SickKids), minimally invasive procedures are performed to diagnose and treat a variety of congenital heart defects. Procedures are performed under general anesthetic and involve inserting a catheter through the skin and into the femoral vein or artery in the groin. In addition, the use of local anesthetic as a pain control regimen just prior to the removal of femoral artery or vein sheaths is used by some but not all cardiac interventionalists. Local anesthetic is infiltrated near the sheath insertion site, at the end of the procedure while the child is under general anesthetic, with the goal of decreasing pain at the insertion site and promoting comfort in the post-operative period. The use of local anesthetic depends on the choice of the individual practitioner and is not currently a routine practice for all patients. The investigators proposed research seeks to investigate whether the use of subcutaneous bupivacaine reduces pain levels in the post-operative period in children having cardiac catheterization procedures. A number of differences in pediatric cardiac catheterization procedures exist that limit the transferability of research findings from the adult literature. For example, the majority of pediatric cardiac catheterizations are performed under general anesthetic, and femoral sheaths are removed while under general anesthetic and at the end of the procedure. In contrast in adult clinical practice, procedures are not performed under general anesthetic, and femoral sheaths are removed when patients are awake and often 4 to 6 hours after the end of the procedure. |
NCT01297387 | This observational prospective study will evaluate, according o usual local clinical practice, feasibility of endoluminal revascularization in diabetic patients with type C and D lesions, according to TASC II Criteria. About 300 patients will be treated with usual revascularization procedure. Each patient will be followed at least 12 months to evaluate clinical outcome and limb salvage interventions. In 2000, the Trans Atlantic Inter-Society Consensus (TASC) stated that patients with CLI should be treated with revascularization, to provide sufficient blood flow to relieve the rest pain and heal skin lesions. TASC also suggested that the best procedure should avoid a general anaesthesia, pose a lesser systemic stress and have fewer serious complications. All these considerations pose peripheral angioplasty (PTA) as the procedure of choice, when feasible. Unfortunately, TASC Recommendations, published in 2000 and confirmed in 2007, use morphological criteria to define guidelines for the choice of revascularization procedure. According to these recommendations, type C and D lesions, which comprise most serious stenosis and occlusions, affecting long tracts of vessels, are candidate to bypass interventions, more than PTA. This choice was due to the first impression, then denied by BASIL study, that PTA could be affected by a reduced efficacy on limb salvage. Diabetic Patients are characterized by high prevalence of long occlusions in crural arteries and this anatomical asset reduces, according to TASC II criteria, the feasibility of Bypass Graft (BPG) in a large number of such patients. |
NCT01397175 | The primary objective of this study is to compare the rate of device-oriented composite consisted of cardiac death, myocardial infarction not clearly attributable to a nontarget vessel, and clinically indicated target lesion revascularization among the patients treated with EES, ZES-R, or BES at 24-month clinical follow-up post-index procedure. Trial end points are summarized in Table I. The hypothesis is that BES is equivalent to EES or BES is equivalent to ZES-R at the primary end point. Previous randomized trials have shown the superior efficacy of drug-eluting stents (DES), such as sirolimus-eluting stent (SES, CYPHER, Cordis, US), paclitaxel-eluting stent (PES, TAXUS, Boston Scientific, US), and zotarolimus-eluting stent (ZES, Endeavor, Medtronic, US) compared with bare metal stents (BMS) by reducing neointimal hyperplasia, late luminal loss, and angiographic restenosis leading to decreased target lesion revascularization. Unfortunately, restenosis still occurs and late stent thrombosis can develop by delaying endoluminal healing or by chronic inflammation.Accordingly, development of new DES is required to improve efficacy by reducing revascularization and safety by reducing the risk of stent thrombosis. With the improvement of polymer, drug, and the platform, the 2nd generation DES, including everolimus-eluting stent (EES, Xience V or Xience Prime, Abbott, USA), zotarolimus-eluting stent with biolinx polymer (ZES-R, Endeavor Resolute or Endeavor Resolute Integrity, Medtronic, USA), and biolimus-eluting stent (BES, BioMatrix or Biomatrix Flex, Biosensors, USA), have been shown to be superior or non-inferior in safety and efficacy trials compared with 1st generation DES. |
NCT01443104 | Coronary artery stents have improved the safety and efficacy of percutaneous coronary intervention for coronary artery disease. Drug-eluting stents have been shown to decrease neointimal hyperplasia and to reduce the rate of restenosis and target-lesion revascularization as compared to bare-metal stents. Drug-eluting stents consist of a metallic platform and a therapeutic substance that is usually released from a polymer matrix. A previous study utilizing a bioresorbable polymer has demonstrated a favorable safety and efficacy profile in a large-scale clinical trial as compared to a first-generation druf-eluting stent (LEADERS trial). The objective of the study is to compare the safety and efficacy of a sirolimus-eluting stent with a biodegradable polymer with an everolimus-eluting stent with a durable polymer in a prospective multicenter randomized controlled non-inferiority trial in patients undergoing percutaneous coronary intervention in routine clinical practice. Background Coronary artery stents have improved the safety and efficacy of percutaneous coronary interventions compared with balloon angioplasty alone (New Engl J Med 1994; 331:489-495). Notwithstanding, restenosis is still encountered in 20 to 30% of lesions after implantation of bare metal stents (JAMA 2000; 284:1828-36) and may require repeat revascularization procedures with a negative impact on quality of life and health care expenditures. Drug-eluting stents with local, controlled release of therapeutic agents have addressed this problem successfully (Circulation 2003; 107:3003-7). Current drug-eluting stents consist of a metallic stent platform and a therapeutic agent, which is either directly immobilized on the stent surface or released from a polymer matrix. |
NCT01479153 | Central venous catheters are needed in the critical care setting to administer drugs. Three sites are available to gain vascular access: subclavian, internal jugular and femoral. Each site has complications, but there is no randomized controlled study which compared the 3 sites. The investigators hypothesis is that subclavian catheterization reduces the risk of major complications compared to internal jugular or femoral. |
NCT01556373 | This study aims to assess the effect of acute inflammation on arterial stiffness and microcirculation. Patients with severe sepsis will be compared with age-, sex- and cardiovascular risk factors-matched controls. The primary outcome is the carotid-femoral pulse wave velocity. The other outcome measures are: systemic hemodynamics (systolic, diastolic, mean and pulse blood pressures, heart rate, cardiac output, left ventricular ejection fraction, systemic vascular resistances), central hemodynamics (aortic systolic, diastolic, mean and pulse pressures, and augmentation index), thenar tissue oxygen saturation, biological makers of inflammation (plasma fibrinogen, C-reactive protein, interleukin-6, matrix metalloproteinases -2, -9, tissue inhibitor of metalloproteinase 1), and plasma catecholamine concentrations (epinephrine, norepinephrine). In a model of acute inflammation induced by salmonella typhi vaccination in healthy volunteers, it has been shown that acute systemic inflammation increased arterial stiffness. Since increased arterial stiffness (assessed by carotid-femoral pulse wave velocity) is an independent prognosis marker of cardiovascular risk in many chronic diseases such as hypertension, renal failure or diabetes mellitus, it could also be a marker of severity in acute inflammation states. Severe sepsis is a leading cause of hospitalisation in intensive care units, and constitutes a state of acute inflammation. It remains however to confirm that arterial stiffness is increased in this clinical conditions before evaluating its prognosis value. |
NCT01599195 | The purpose of the study is to test a new amplified stethoscope(AudioDoc) that can detect the presence of bruit by using an acoustic signal to represent the bruit. This pilot study will address two questions: is there a detectable difference in recorded sound signal of carotid and femoral bruit when compared to sound signals captured when there is no bruit present; is the use of a visual recorded signal more accurate in identifying carotid and femoral bruit when compared to traditional auscultation with a regular stethoscope and ultrasound. Recorded signals are stored on a laptop computer. The signals later undergo Fourier analysis are then compared to the findings on carotid ultrasoud as to degree of stenosis. Subjects with high grade stenosis in which no bruit was ascultated but in which carotid ultrasound data suggests a bruit may be present are studied for soft /inaudible bruits. When available, data will be correlated to CT/conventional angiographic studies. |
NCT01600482 | The objective of the CELT ACD® Vascular Closure Device study is to evaluate the safety and effectiveness of the CELT ACD® device to achieve hemostasis of the common femoral artery access site in patients on anticoagulation who are undergoing a percutaneous coronary intervention (PCI) procedure using either a 6F or 7F procedural sheath. |
NCT01631448 | Globally there have been about 45,000 kidney transplants last year. Currently, the overall survival of renal transplant receptors is 95% in the first year and 85% at 5 years. A major challenge to overcome by the renal transplant surgeons, are surgical complications which may impact on patient morbidity and mortality, as well as graft function. The aim of the study is to assess whether application of fibrin seal prevents postoperative complications in patients undergoing kidney transplantation. Controlled clinical trial with single-blind evaluation in patients surgically intervened kidney transplantation. It will include all patients undergoing renal transplantation in this Medical Center, any gender and over than 16 years and under 60 years. INTRODUCTION: Globally there have been about 45,000 kidney transplants last year. Currently, the overall survival of renal transplant receptors is 95% in the first year and 85% at 5 years. A major challenge to overcome by the renal transplant surgeons, are surgical complications which may impact on patient morbidity and mortality, as well as graft function. Since 2000 to date the specialties Hospital from the Western Medical Center of the Mexican Institute of Social Security, is the hospital where the greatest number of kidney transplants are performed, reporting to December 2005 a total of 990 cases, with an average of 200 transplants annually. Since the completion of the first kidney transplants, there has emerged the presence of complications related to the surgical procedure, which have influenced the morbidity and mortality in transplant patients. |
NCT01683448 | This study will be a retrospective study. The patient data from the electronic medical records and existing database will be collected and analyzed. Primary endpoints will be postoperative mortality (within 30 days) and overall complications and length of hospital stay. The secondary endpoints will be myocardial infarction, cardiac death, CHF, arrhythmia, ischemia, stroke, neurological complications, length of ICU stay, re-admission rate, infections, pulmonary complications, length of intubation time, length of ventilation time, and acute renal failure. Each year about 694,000 Americans have open-heart surgery including valve repairs, valve replacements, heart transplants, and coronary artery bypass graft (CABG) surgery [1]. The reported incidence of perioperative complications in these cardiac surgery patients is 4.5% while the prevalence varied from1.6% to 14.1% [2,3]. As the population ages, increased numbers of elderly patients with more advanced cardiac diseases and comorbidities are being referred for cardiac surgery. For these patients, postoperative cardiovascular complications (cardiac death, myocardial infarction (MI), ischemia, congestive heart failure (CHF), arrhythmia, stroke, and acute renal failure (ARF)) represent the major postoperative complications [4-6]. These complications translate into increased mortality, prolonged hospital stay and estimated costs exceeding $20 billion annually [7]. These events may be triggered by surgical stress responses that result in increased plasma levels of norepinephrine and epinephrine [8], myocardial oxygen supply demand imbalance, and plaque rupture [9]. |
NCT01691911 | Major vascular surgery involves operations to repair swollen blood vessels, clear debris from blocked arteries or bypass blocked blood vessels. Patients with these problems are a high-risk surgical group as they have generalized blood vessel disease. These puts them at risk of major complications around the time of surgery such as heart attacks , strokes and death. The mortality following repair of a swollen main artery in the abdomen is about 1 in 20. This contrasts poorly with the 1 per 100 risk of death following a heart bypass. Simple and cost-effective methods are needed to reduce the risks of major vascular surgery. Remote ischaemic preconditioning (RIPC) may be such a technique. To induce RIPC, the blood supply to muscle in the patient's arm is interrupted for about 5 minutes. It is then restored for a further five minutes. This cycle is repeated three more times. The blood supply is interrupted simply by inflating a blood pressure cuff to maximum pressure. This repeated brief interruption of the muscular blood supply sends signals to critical organs such as the brain and heart, which are rendered temporarily resistant to damage from reduced blood supply. Several small randomized clinical trials in patients undergoing different types of major vascular surgery have demonstrated a potential benefit. This large, multi-centre trial aims to determine whether RIPC can reduce complications in routine practice. The demand for major vascular surgery is increasing [1]. |
NCT01745692 | Ischaemic strokes (those caused by blockage in an artery in the brain caused by a blood clot) can be treated with very early use of clot-busting (thrombolytic) drugs to attempt to restore the blood supply and limit the damage, resulting in an increased proportion of people making a recovery to independence after stroke. However, drug treatment only succeed in restoring blood flow in a minority of people with clots in the larger arteries (10-25% depending on the size of the blood vessel) and these people also have the most severe strokes and highest risk of death or dependence as a result of the stroke. Current best treatment is therefore least effective in the group with the most severe strokes. Devices that can be fed through the blood vessels to either remove or break up the blood clot in the brain vessels can open this type of large artery blockage. However, using these devices is a highly skilled procedure and it takes some time both to set up the necessary facilities (including anaesthetic, nurses and medical support) and to reach the blockage. The extra time that is required to use these devices may mean that brain tissue is already irreversibly damaged. If so, then an individual patient cannot benefit and indeed may be harmed by opening the artery. There are no completed clinical trials comparing the outcome in people treated with standard stroke treatment and those treated with devices. |
NCT01776151 | The purpose of this study is to find out if starting anti-retroviral therapy (ART) above 500 cluster-of-differentiation-4 (CD4)+ cells/milliliter (mL) ('early ART group') is better at reducing the stiffness of arteries than waiting to start ART until the CD4+ drops below 350 cells/mL ('deferred ART group'). Artery stiffness has been associated with an increased risk of cardiovascular (heart) disease, and could be useful as an earlier indicator of heart disease. In this study, the stiffness of arteries will be measured at study entry, months 4, 8, 12, and annually thereafter, using a tonometer on the participant's forearm. |
NCT01855698 | The primary objective of the study is to assess efficacy and safety of different prophylactic or therapeutic antithrombotic approaches in patients with hematologic neoplasms and platelet count <50 x109/L, including unfractionated or low molecular weight heparin, fondaparinux, anti-vitamin K agents, antiplatelet agents, novel oral anticoagulants, fibrinolytic agents, with or without a policy of platelet transfusion. Cases with arterial or venous thromboembolism managed with observation or use of vena cava filters in patients with venous thromboembolism will be included too. Illness treatment overview The incidence of venous thromboembolism (VTE) among patients with haematological malignancies has been recently reviewed (1). For patients with lymphoma, the incidence of VTE ranged from 1.5 to 14.6% and is 59% in patients with central nervous system lymphoma. The incidence of VTE in patients with acute leukaemia varies with time, being between 1.4 and 9.6% at diagnosis and between 1.7 and 12% during induction therapy. Notably, the highest rates of VTE were reported in patients with acute promyelocytic leukaemia, with values between 6 and 16% in the largest series. In patients with multiple myeloma who did not receive antithrombotic prophylaxis, the rate of VTE increased to 26% in those undergoing treatment regimens including immumodulatory drugs (thalidomide and lenalidomide) (1). Moreover, in patients who have undergone autologous or allogeneic haematopoietic stem cell transplantation (HSCT), the rate of VTE is between 2.9 to 9.9%, and was central venous catheter (CVC)-associated in the majority of cases (2-4). |
NCT01868698 | Peripheral arterial disease (PAD) is a pathological condition limiting, resulting from a narrowing or occlusion of the artery diameter due to aneurysms, inflammation, atherosclerosis and thromboembolic events. One of the main risk factors for the development of DAP is diabetes mellitus due to its relation to the process of atherogenesis. Thus, the objective of this study is to evaluate the effects of three treatment modalities for PAD on the blood flow velocity. It is a crossover study. Fifteen women with diabetes receive three types of treatment, the order defined according draw: high voltage electrical stimulation, shortwave diathermy and kinesiotherapy. The blood flow of the lower limb will be assessed by Doppler ultrasound. The hypothesis of this study is that physical therapy resources increase the circulation of the lower limb. |
NCT01870310 | It is a randomized prospective controlled study evaluating the effect of transcatheter renal denervation on the clinical status of patients with chronic heart failure and its safety procedures. The working hypothesis of the study is that by performing transcatheter renal denervation in patients with chronic heart failure and severe left ventricular systolic dysfunction there will a resultant reduction in the renal sympathetic activation which in turn will reduce the number of hospitalizations and deaths from heart failure. Chronic heart failure in the European countries occurs in 2-3% of the population with a significant increase in the higher age groups (1). Improved treatment of acute conditions (especially myocardial infarction) has resulted in more patients entering into the category of chronic heart failure. Chronic heart failure has a poor prognosis. Diagnosis and treatment are challenging both medically and economically. Half of the patients with systolic heart failure die within 4 years and more than 50% of patients with severe heart failure (NYHA functional class of IV) die within one year (1). The current treatments for heart failure are not only aimed at influencing the symptoms, but also preventing the progression of heart failure to reduce mortality. Heart failure leads to the activation of compensatory mechanisms designed to restore adequate cardiac output. These mechanisms are initially beneficial, but their long-term activation leads to further progression of the pathological process and deterioration of cardiac function. |
NCT01943344 | The purpose of this Clinical Investigation is to gather feasibility data on the clinical use of the VIVASURE CLOSURE DEVICE™ in relation to safety, and to confirm its performance to percutaneously close femoral arterial puncture sites in the range of 18-24 F, post endovascular procedures. This study will be a prospective, multi-centred, non-randomized pilot study to investigate the safety and performance of the VIVASURE CLOSURE DEVICE™. All patients undergoing a procedure requiring an arteriotomy in the range of 18 to 24 F, via the common femoral artery will be screened against the inclusion/exclusion criteria. If the patient meets the requirements of the clinical investigation, they shall be invited to participate, provide informed consent and shall subsequently be assigned a subject number. Patient safety will be monitored closely by the Data Safety Monitoring Committee (DSMC). Safety data will be reported to the DSMC for every patient with a reported complication. The DSMC will adjudicate on the safety data to determine whether it is safe to continue enrolment. Subjects shall have a 1, 3 and 12 month follow-up assessment. Safety data from the follow-ups will be assessed by the Data Safety Monitoring Committee. This protocol will adopt the VARC-2 definitions for major vascular complication associated with closure of the access site. This pilot study will enrol approximately 10 subjects. The study is designed to support a larger CE Mark study. As such, a study safety assessment will be complete when all patients have completed their 1 month follow-up assessment. |
NCT02033720 | After successful resuscitation from certain types of cardiac arrest, total body cooling is now a well established treatment that improves the chances of the brain recovering. This however, has only been definitively proven after a certain type of cardiac arrest that is "ventricular fibrillation / ventricular tachycardia". The purpose of this study is to explore if total body cooling is beneficial for patients recovering from another type of cardiac arrest that is "pulseless electrical activity". HYPOTHESIS: Patients undergoing post-cardiac arrest therapeutic hypothermia have better neurological outcomes if their initial arrest rhythm is pulseless electrical activity (PEA) in comparison to asystole. STUDY RATIONALE AND BACKGROUND INFORMATION: After successful resuscitation from cardiac arrest the body experiences a period of global reperfusion. During this period, patients may show signs of myocardial stunning, lactic acidosis, neurological injury and reperfusion syndrome. This constellation of findings constitutes what is known as post-cardiac arrest syndrome. The brain appears to be one of the most vulnerable organs to injury during this reperfusion phase and varying degrees of cognitive impairment may be the end result. Inducing mild therapeutic hypothermia has been shown to be protective for the brain in this setting and has been demonstrated to improve neurological recovery. The evidence for this however, is only conclusive in cases where the arrest is in a shockable rhythm i.e. pulseless ventricular tachycardia and ventricular fibrillation. In 2002, two randomized controlled trials were published showing an improvement in neurological outcomes in patients treated with mild therapeutic hypothermia post resuscitation from shockable cardiac arrest. |
NCT02069275 | The purpose of this study is to investigate the frequency of bleeding and haematomas in patients undergoing coronary angiography or percutaneous coronary intervention via femoral artery and mobilized immediately after the procedure, compared to those mobilized after two hours (following the standard regimen). At the same time the investigators will investigate whether it reduces the discomfort being mobilized immediately after the procedure. The frequency of hematoma, bleeding or pseudoaneurysm at the access site in the groin is 7-15% with regimens that involve 0-2 hours of bed rest, somewhat more frequent after Percutaneous coronary intervention (PCI) than coronary angiography (CAG). There seems to be no reduction in the complications of the CAG or PCI by maintaining the bed rest for more than 2 hours after the procedure. Angio-Seal seems most effective of current closure devices. There is less discomfort associated with early compared with late mobilization. Protamine reverse heparin's effect without the side effects of that regime. There lacks a larger randomized study of the safety of mobilizing patients immediately after CAG and after PCI. |
NCT02074371 | Coronary artery bypass graft surgery (CABG) is associated with postoperative respiratory depression. In this study we aimed at investigating perioperative parameters that could predict the nadir of postoperative respiratory function impairment. Coronary artery bypass graft (CABG) surgery is a principal revascularization option for ischemic heart disease and the principal modality for invasive treatment of coronary artery disease. Postoperative pulmonary complications are the most frequent and significant contributor to length of hospitalization, morbidity and mortality. The objective of this study is to search for perioperative parameters that could predict the degree of impairment of respiratory function after CABG with cardiopulmonary bypass (CPB). |
NCT02097186 | Major vascular surgery involves operations to repair swollen blood vessels, clear debris from blocked arteries or bypass blocked blood vessels. Patients with these problems are a high-risk surgical group as they have generalized blood vessel disease. These puts them at risk of major complications around the time of surgery such as heart attacks , strokes and death. The mortality following repair of a swollen main artery in the abdomen is about 1 in 20. This contrasts poorly with the 1 per 100 risk of death following a heart bypass. Simple and cost-effective methods are needed to reduce the risks of major vascular surgery. Remote ischaemic preconditioning (RIPC) may be such a technique. To induce RIPC, the blood supply to muscle in the patient's arm is interrupted for about 5 minutes. It is then restored for a further five minutes. This cycle is repeated three more times. The blood supply is interrupted simply by inflating a blood pressure cuff to maximum pressure. This repeated brief interruption of the muscular blood supply sends signals to critical organs such as the brain and heart, which are rendered temporarily resistant to damage from reduced blood supply. Several small randomized clinical trials in patients undergoing different types of major vascular surgery have demonstrated a potential benefit. This large, multi-centre trial aims to determine whether RIPC can reduce complications in routine practice. The demand for major vascular surgery is increasing [1]. |
NCT02163031 | Orthotopic heart transplantation is a well established therapeutic measure for end stage heart failure, leading to significant improvements in survival and quality of life. In the routine clinical practice, orthotopic heart transplantation patients receive periodic cardiac catheterization for early detection of allograft vascular disease. The coronary angiography of these patients is characterized for several technical difficulties, generally related to the presence of the aortotomy with anomalous implantation of the coronary ostia and to the orthotopic position of the allograft. For these reasons, trans femoral approach is usually preferred. In the last two decades, trans radial approach for coronary angiography emerged to be effective, safe and able to improve patient comfort. However, there is no universal consensus on the optimal choice of radial access from either the left or the right artery. Currently, this choice is largely dependent on the operator's preference. The trans right radial approach is generally preferred in routine clinical practice mainly due to its easier catheter manipulation for the operators from patient's right side, and the current design of radial compression devices for the right wrist in medical market. As such, a major barrier to prevent the wide adoption of the left radial access lies in some difficulty to reach the left wrist leaning over the patient, particularly for shorter operators or in obese patients. However, a great deal of attention has been recently directed toward the trans left radial access, as it has an important anatomical advantage due to the vascular anatomy of epiaortic vessels with a straighter route to the left coronary ostium, which could also reduce the risk of cerebrovascular complications. |
NCT02200783 | Excessive radiation received by the operator has been described as a possible drawback of the radial catheterization technique when compared with the femoral access. The study hypothesis is that the use of radial access device dedicated radioprotective TRIPTable ® (Transradial Intervention Table Protection) is not inferior to standard femoral technique and superior to standard radial technique as radioprotection strategy to the operator in patients with acute coronary syndromes acute and submitted to cardiac catheterization. This study is prospective, 1:1:1 randomized, unicentric, comparative between femoral and radial radial technique with and without dedicated TRIPTable ® device. The TripTable device is a polycarbonate support table anatomically-designed to facilitate the radial technique, facilitating the puncturing, positioning, support to work material and providing further radioprotection from a lead layer without obstruction in viewing the fluoroscopic images. |
NCT02216305 | HYPOTHESIS 1. HAL- RAR causes a lower immediate postoperative pain compared with erxcision hemorrhoidectomy. 2. HAL - RAR achieves similar immediate and long term results compared to the excision hemorrhoidectomy in the control of hemorrhoidal symptoms. 3. The complication rate of HAL- RAR is low and similar to excision hemorrhoidectomy. OBJECTIVES 1. Compare postoperative pain of both techniques. 2. Assess the short and long-term control of hemorrhoidal symptoms by HAL- RAR technique, and compare the results with those of the excision hemorrhoidectomy. 3. Evaluate and compare the rate of complications of both techniques. 4. Assess the quality of life of patients before and after treatment. MATERIAL AND METHODS The trial was subjected to evaluation and accepted by the Ethics Committee of the Fundació Unió Catalana d'Hospitals (Catalonian Union of Hospitals Foundation). All patients with grade III and IV hemorrhoids that are eligible for surgical treatment with both methods who agree to participate in the study, will be included in the prospective randomized trial. All patients will be required to sign the specific informed consent. Patients who are suitable for treatment with both techniques will be randomly assigned to the surgical technique. Inclusion criteria: 1. Patients with symptomatic grade III or IV hemorrhoids (bleeding, pain, itching, soiling or prolapse) that are eligible for surgical treatment with both methods. Exclusion criteria: 1. |
NCT02237430 | Is the MynxGrip (test device) non-inferior to manuel compression (standard comparator) in the incidence of adverse access site related events in-hospital, at 30 days and at 6 months. Prospective, randomized (1:1), controlled, non-blinded, single center study in 2000 patients comparing the MynxGrip (test device) and manuel compression (standard comparator). Safety and efficacy endpoints will be reported for in-hospital, 30 days and 6 months. |
NCT02241642 | The purpose of this Clinical Investigation is to validate that the clinical use of the VIVASURE CLOSURE DEVICE™ is safe for the operator, patient and third parties, and to confirm its performance to percutaneously close femoral arterial puncture sites in the range of 18-24 F, post endovascular procedures. This is a non-inferiority study based on safety. Safety will be assessed by incidence and severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation is no worse than those associated with cut-down and sutured close. This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the VIVASURE CLOSURE DEVICE™. The study shall not be blinded prior to, during or post the procedure. All patients undergoing a procedure requiring an arteriotomy in the range of 18 to 24 F, via the common femoral artery will be screened against the inclusion/exclusion criteria. If the patient meets the requirements of the clinical investigation, they shall be invited to participate, provide informed consent and shall subsequently be assigned a subject number. All subjects shall have an immediately post procedure, 24 hour, 1, 3 and 12 month follow-up assessment. Safety data from the follow-ups will be assessed by the Data Safety Monitoring Committee. |
NCT02264964 | The duration and adverse events of non-cuffed catheter in patients with hemodialysis will be investigated by multicenter prospective cohort. Totally, 1,400 patients with chronic renal failure requiring hemodialysis will be enrolled. 900 patients will be given right internal jugular catheterization, and the other 500 patients unsuitable for right internal jugular catheterization will receive femoral catheterizations. Every patient will be followed-up for six months. During following-up period, the duration time and adverse events of non-cuffed catheter will be recorded in details, including inadequate hemodialysis blood flow, venous stenosis, venous thrombosis, infection, catheter thrombosis and so on. The central vein will be evaluated by CT Angiography to identify its stenosis at last visit after 6 months. This multicentre trial will provide evidence to develop guideline for duration time of using non-cuffed catheter. |
NCT02341196 | This study examines the risk of thrombogenicity of the carotid patches in polyurethane compared to carotid patches in polyester including death, any stroke, carotid thrombosis at 30 days and long-term results including stroke and recurrent carotid stenosis at 10 years. This study was run at the University of Roma, La Sapienza and at the University of Poitiers, randomisation was done in both enters after approval by the Ethical committee of the University of Roma (Record uploaded) This study examines the risk of thrombogenicity of the carotid patches in polyurethane compared to carotid patches in polyester including death, any stroke, carotid thrombosis at 30 days and long-term results including stroke and recurrent carotid stenosis at 10 years. 598 patients were considered for randomisation between January 1995 and January 2004. The following patients were excluded for randomisation (Redo carotid surgery: N=34, radiation induced carotid stenosis:N=45, indication for carotid bypass: N=65, Refusal of randomisation: N=4). In total, 450 patients were randomized in two groups, 225 received a polyester patch and 225 received a polyurethane patch. All patients were operated under general anaesthesia and all received an intraoperative angiography. A shunt was selectively used in patients with a recent stroke (<15 days) or with a contralateral carotid occlusion |
NCT02389023 | The purpose of this study is to evaluate the effectiveness of negative pressure incision management system (Prevena™ Incision Management System (PIMS) or ActiVAC® with the Prevena™ Dressings (Peel and Place™ or Customizable™), KCI) in the prevention of wound complications including surgical site infection (SSI) and non-infectious complications in patients undergoing vascular surgery with groin incisions. Complications such as surgical site infections, deep wound infections, prosthetic graft infections, and non-infections problems such as wound dehiscence continue to cause significant morbidity for patients undergoing arterial reconstruction for peripheral arterial disease. Patients undergoing leg bypass surgery for limb salvage are at particular risk due to their medical problems such as diabetes and renal failure and location of incisions along the groin area. Surgical site infections (SSI) are estimated to occur in 5-40% of patients undergoing arterial bypass for lower extremity arterial occlusive disease. The in-hospital SSI rate is 5% across the Vascular Study Group of New England, a regional quality improvement registry. Factors contributing to wound infections include patient factors such as advanced age and comorbidities such as obesity, diabetes and renal insufficiency and surgical factors including the division of local lymphatics in the groin, placement of a prosthetic graft and inherent difficulty in keeping an incision across the groin crease covered, dry and protected. Despite the use of standard sterile technique and perioperative preventative antibiotics infections these complications continue to cause patient morbidity. |
NCT02419053 | The purpose of this study is to see if the surgical safety checklist is associated with a reduction in perioperative complications for children undergoing surgery in Ontario, Canada. |
NCT02426710 | Background: Radiofrequency ablation of typical atrial flutter present the most effective treament option in treatment of atrial flutter. Despite its high efficacy, due tovariant anatomy of cavotricuspid isthmus (CTI), i.e. location of right coronary artery, pouches, the achievment of complete bidirectional block across the CTI is sometimes chalenging. Intracardiac echocardiography (ICE) is a very usefull tool for on-line vizualization of the anatomy of the atria and also for the location of catheter position on CTI during ablation. If the routine use of ICE is associated with easier atrial fluter ablation is not clear. Methods: One hundred consecutive patients indicated for typical atrial flutter ablation will be enrolled into the study. The patients will be randomized into group (A) ablation with use of ICE and (B) ablation without ICE. The ablation will be done in both groups by two diagnostic catheters (10-pole positioned in coronary sinus and 20-pole halo catheter positioned in the right atrium) and radiofrequency ablation catheter. The end-point of the ablation is the achievment of the bicidrectional block across the CTI. The end-points of the study are 1) the total length of the procedure, 2) the fluoroscopy time and 3) the ablation time. The safety end-point is clinically significant bleeding from the groin due to additional puncture for ICE catheter. Discussion: We hypothesize the use of ICE wil shorten the radiofrequency energy delivery, fluoroscopy time and the length of the procedure without increasing the bleeding. |
NCT02453321 | Recently, several articles have suggested or reported that Adductor Canal Blocks (ACBs) offer adequate or equal analgesia and may promote better performance in early rehabilitation following Total Knee Arthroplasty (TKA) when compared to the more commonly used Femoral Nerve Block (FNB). A common feature of these studies has been the use of moderate to high concentration local anesthetics (e.g. 0.2% or 0.5% Ropivacaine respectively) which when injected by a large motor nerve will inevitably cause weakness. However, the practice at our institution has long been a continuous femoral nerve block (CFNB) with a lower concentration local anesthetic (0.0625% Bupivacaine). Over the past several years the investigators have performed several thousand CFNBs using this technique which has offered the advantage of minimal motor weakness and adequate analgesia. The primary goal of this study is to determine if our established practice of using a low concentration continuous FNB inserted about 5cm caudal to the groin crease (the apex of the femoral triangle) using a low infusion rate of 2ml/hr is comparable to the emerging practice of inserting a Continuous Peripheral Nerve Block (CPNB) in the anatomic adductor canal (AC) - infusing at 4ml/hr. A secondary goal is to study the effect of cumulative volume of local anesthetic infused through a FNB when at a rate of 2ml/hr compared to a rate of 4ml/hr in the 48-hour postoperative period. |
NCT02519933 | A well-functioning vascular access is essential for effective hemodialysis. The native arteriovenous fistula (AVF) is the preferred vascular access because of the lower thrombosis and infection risks compared to either synthetic arteriovenous grafts or central venous catheters. Brachiocephalic arteriovenous fistula (BCAVF) and transposed brachiobasilic arteriovenous fistula (T-BBAVF) are recommended when there is either a primary failure or no suitable vessels for the forearm fistula. However, BCAVF is frequently cannulated at the antecubital fossa, the risks of stenosis and thrombosis are high, which will compromise proper BCAVF function and survival. T-BBAVF is not only technically challenging, but also associates with severe arm swelling and pain. Thus, the investigators introduced a novel modified Non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) for long-term hemodialysis patients. To confirm its efficacy, a prospective clinical study would be carried out. The study aims to compare the outcomes of a novel modified Non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) and the standard brachiocephalic arteriovenous fistula (BCAVF) for long-term hemodialysis patients. Briefly, in mNT-BBAVF, a side-to-side anastomosis between the brachial artery and non-transposed proximal basilic vein is disposed, followed by the ligation of the vein above anastomosis. All the perforating in the surgical field should be ligated. All patients will be followed up for 12 months after surgeries. The outcomes includes: hemodynamic parameters (vessels's diameters, blood flow velocities and blood volumes) detected by ultrasound in 12 months, Complications in 1-month and 12-month, primary patency and secondary patency (cumulative patency). |
NCT02525926 | Pulmonary hypertension is a rare condition that leads to right ventricular dysfunction and premature death. Only modest improvements of outcomes have been observed with the current available advanced specific drug therapy. Pulmonary hypertension advanced therapy is also expensive and leads to frequent adverse effects, sometimes serious. Results from a pilot study, the first-in-man experience of pulmonary artery denervation, demonstrated a clinical improvement in 13 patients with severe pulmonary hypertension despite optimal medical management. However this single non-randomized study requires confirmation. The investigators propose a prospective multi-center, randomized, single-blinded trial. Its main objective will be to assess, in patients with uncontrolled pulmonary hypertension despite optimal medical management, the efficacy of pulmonary artery denervation in reducing mean pulmonary artery pressure (mPAP) at six months, compared to continued medical treatment following a simulated (sham) procedure. The principal evaluation criteria will be the mPAP change (in mm Hg) as measured by right heart catheterization. The study will run for 18 months and it will be necessary to recruit 50 patients. All adult patients (with the exception of pregnant women and individuals unable to receive an appropriate information and to give their free and informed consent) with uncontrolled pulmonary arterial hypertension despite optimal medical management will be invited to participate, in the absence of any exclusion criteria. The investigators will also measure changes in clinical, biological, echocardiographic and hemodynamic prognostic markers in both groups. |
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