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Vascular Diseases clinical trials

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NCT ID: NCT00966836 Recruiting - Clinical trials for Heart Transplantation

Prevention of Transplant Atherosclerosis With Everolimus and Anti-cytomegalovirus Therapy

PROTECT
Start date: April 2009
Phase: Phase 3
Study type: Interventional

Cardiac allograft vasculopathy (CAV) is the major cause of long-term graft failure in heart transplant recipients. Although several immune-mediated and metabolic risk factors have been implicated in the pathogenesis of CAV, no effective therapy is currently available to treat established CAV and prevent its adverse outcomes. Therefore, the main clinical strategy is based on prevention and treatment of factors known to trigger its development. Although the mechanism is vague, cytomegalovirus (CMV) infection is believed to play a key role in CAV progression. Two strategies involving administration of specific anti-CMV agents are recommended for prevention of CMV infection/disease: universal prophylaxis and preemptive therapy. The pros and cons of the two strategies are still debated, in the absence of randomized studies addressing graft-related outcomes and viral mechanisms of graft damage, and without any clear evidence of superiority of either approach. The investigators conceived this randomized prospective project to compare the effect of preemptive anti-CMV strategy with universal anti-CMV prophylaxis on CMV infection and on one-year increase in coronary intimal thickening. Patients will be additionally randomized to receive either mycophenolate mofetil or everolimus, in light of the possible anti-CMV properties of everolimus.

NCT ID: NCT00965315 Available - Diabetes Clinical Trials

A Multicenter Randomized Parallel-group Study to Investigate the Efficacy of a Combination of Rosuvastatin and Fenofibrate in the Patients With Diabetes or Atherosclerotic Vascular Diseases With Metabolic Syndrome

Start date: n/a
Phase: N/A
Study type: Expanded Access

Diabetic patients have an excess risk of mortality due to cardiovascular diseases (CVD) compared to non-diabetics. Cardiovascular disease mortality rate is reportedly on the rise in several countries in the region, including urban China, Malaysia, Korea and Taiwan. Cardiovascular diseases and stroke are always the number 2 and 3 killers for Taiwanese population in recent years, and they really cost much from our medical resource. For treating dyslipidemia, one of the major risk factor for CVD, statins have been well documented to reduce CV deaths both for primary and secondary prevention in several large-scale trials. It has been reported that the clinical benefits of treating dyslipidemia in patients with diabetes mellitus should be at least equivalent to the benefits observed among those with cardiovascular disease. A meta-analysis of seven trials of statins found that treatment for about 5 years resulted in a 25% reduction in the combined outcome of coronary heart disease death and non-fatal myocardial infarction. Fibrates are another group of hypolipidemic drugs that regulate lipid metabolism and are used quite often in daily practice for diabetic dyslipidemia, because of its beneficial effect to reduce high TG and increase low HDL-C, which are the characteristic lipid abnormalities commonly seen in the patients with diabetes or metabolic syndrome. However, in recently published FIELD study, fenofibrate did not significantly reduce the risk of the primary outcome of coronary events in 9,795 participants with type 2 diabetes mellitus. The higher rate of starting statin therapy in patients allocated placebo might have masked a moderately larger treatment benefit. Furthermore, all the treatment trials to back up the lipid treatment guideline were conducted in Caucasians and no data about the combination therapy with fibrate and statin was published before.

NCT ID: NCT00956332 Active, not recruiting - Clinical trials for Peripheral Arterial Disease

Safety Study of MultiGeneAngio in Patients With Chronic Critical Limb Ischemia

Start date: February 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and activity of two doses of MultiGeneAngio, a cell therapy product produced from the patient's own cells, as potential treatment for patients with chronic critical limb ischemia.

NCT ID: NCT00951210 Completed - Clinical trials for Peripheral Artery Disease

Safety of Intramuscular Injections (IM) of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia (CLI)

Start date: August 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety of PLX-PAD, Intra-muscular injections for the treatment of CLI patients.

NCT ID: NCT00949286 Completed - Clinical trials for Diabetes Mellitus, Type 2

Action in Diabetes and Vascular Disease Preterax and Diamicron MR Controlled Evaluation Post Trial Observational Study

ADVANCE-ON
Start date: January 2010
Phase: N/A
Study type: Observational

The study is designed to determine the long term, post trial effects of the two interventions studied in ADVANCE (routine blood pressure lowering with perindopril-indapamide as compared with placebo and intensive gliclazide-MR based glucose control as compared to standard guideline based glucose control) in individuals with type 2 diabetes at high risk of cardiovascular events. The long term, post randomization effects of the two study interventions will be investigated separately as they were for the main trial. This study will clarify and quantify the long-term, post trial (often referred to as legacy) effects of these two interventions in a broader population of patients with type 2 diabetes from high and low to middle income countries, and in the setting of comprehensive cardiovascular risk factor treatment. With the ADVANCE trial infrastructure and surveillance system already in place, the implementation of extended follow-up will be feasible. The conclusions of this follow up study will have profound clinical implications for the care of patients with type 2 diabetes around the world.

NCT ID: NCT00947323 Completed - Clinical trials for Erectile Dysfunction

Simvastatin for Treating Erectile Dysfunction

STED
Start date: January 2006
Phase: Phase 3
Study type: Interventional

This is a randomized clinical trial, double-blind, placebo controlled, to verify if simvastatin can improve erectile dysfunction in men with endothelial dysfunction, without any cardiac disease.It is hypothesized that the simvastatin can improve the endothelial function, improving the nitric oxide liberation in corpora cavernosa of the penis, resulting in improvement of erection.

NCT ID: NCT00935766 Terminated - Hypertension Clinical Trials

Effect of Fish Oil (Omega-3 Fatty Acids) on Arteries

Start date: September 2009
Phase: Phase 3
Study type: Interventional

The overall objective of LUCHAR Specific Aims 4.1 and 4.2 is to assess the additional contribution of cardiovascular disease (CVD) risk markers to traditional biomedical risk factors in the prediction of pre-clinical CVD. Specific Aim 4.3 will test the impact of omega-3 fatty acid supplementation on risk markers and pre-clinical markers of CVD in Hispanic patients. Specific Aim 4.3: Conduct a randomized, placebo-controlled trial of the effect of omega-3 fatty acid supplementation on vascular function as measured by brachial artery reactivity (BAR) and on circulating inflammatory markers. Hypotheses: 1. Daily omega-3 fatty acid supplementation will improve vascular function in subjects at high risk for CVD. 2. Daily omega-3 fatty acid supplementation will reduce inflammatory protein panel scores in subjects at high risk for CVD.

NCT ID: NCT00934037 Completed - Clinical trials for Coronary Artery Disease

Combined Non-invasive Coronary Angiography and Myocardial Perfusion Imaging Using 320 Detector Computed Tomography

Core320
Start date: December 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the diagnostic accuracy of multi-detector computed tomography using 320 detectors for identifying the combination of coronary artery stenosis ≥ 50% and a corresponding myocardium perfusion defect in a patient with suspected coronary artery disease compared with conventional coronary angiography and single photon emission computed tomography myocardium perfusion imaging.

NCT ID: NCT00933270 Completed - Clinical trials for Peripheral Vascular Disease

Comparison of the SUpera® PERipheral System in the Superficial Femoral Artery

SUPERB
Start date: July 2009
Phase: Phase 3
Study type: Interventional

This is a prospective, multicenter, non-randomized, single arm, pivotal trial. The main objective of this study is to demonstrate the safety and effectiveness of the IDev SUPERA® Nitinol Stent System in treating subjects with obstructive superficial femoral artery (SFA) disease. The primary endpoint will be the primary patency of the SFA evaluated at 12 months. The outcome will be compared to a performance goal based on clinical trials of percutaneous transvenous angioplasty (PTA) alone.

NCT ID: NCT00930813 Completed - Atherosclerosis Clinical Trials

LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis

LEVANT I
Start date: June 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to assess the safety and efficacy of the Lutonix Catheter for treatment of stenosis of the femoropopliteal arteries by direct comparison to standard balloon angioplasty.