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Ischemia clinical trials

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NCT ID: NCT01023789 Completed - Clinical trials for Coronary Artery Disease

ABSORB EXTEND Clinical Investigation

ABSORB EXTEND
Start date: January 2010
Phase: N/A
Study type: Interventional

The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System ABSORB BVS is currently in development at Abbott Vascular.

NCT ID: NCT01021319 Completed - Clinical trials for Acute Ischemic Stroke

Identification of Stroke Patients ≤ 3 and ≤ 4.5 Hours of Symptom Onset by Fluid Attenuated Inversion Recovery (FLAIR) Imaging and Diffusion Weighted Imaging (DWI)

PRE-FLAIR
Start date: September 2009
Phase:
Study type: Observational

The aim of the study is to evaluate the use of combined fluid attenuated inversion recovery (FLAIR) imaging and diffusion weighted imaging (DWI) as surrogate marker of lesion age within the first 6 hours of ischemic stroke in order to identify patients ≤ 3 or ≤ 4.5 hours of symptom onset in a large multicenter study hours of ischemic stroke. The investigators hypothesize that the pattern of a visible lesion on DWI together with a negative FLAIR ("DWI-FLAIR mismatch") will identify patients ≤ 3 hours of symptom onset with >80% specificity and positive predictive value.

NCT ID: NCT01019733 Completed - Cerebral Palsy Clinical Trials

Intrathecal Stem Cells in Brain Injury

ISC
Start date: July 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether the plasticity of autologous intrathecal hematopoietic cells would improve the neurologic evolution of the pediatric patients with hypoxic/ischemic brain injury.

NCT ID: NCT01014975 Completed - Clinical trials for Acute Ischemic Stroke

A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients

Start date: November 2009
Phase: Phase 1/Phase 2
Study type: Interventional

This study tests the drug, Plasmin (Human), in patients with a stroke due to a clot in the middle cerebral artery (MCA). Plasmin is an enzyme that causes clot lysis by cleaving a clot component, fibrin. In this study, Plasmin (Human) is administered locally through a catheter to the clot within 9 hours of the stroke onset. Three doses of Plasmin (Human) (20 mg, 40 mg, and 80 mg) are being tested in 3 different groups of patients. Patients are monitored by imaging of the affected artery and functional testing.

NCT ID: NCT00987974 Completed - Clinical trials for Endothelial Dysfunction

Short Term Statin Treatment and Endothelial Dysfunction Due to Ischemia and Reperfusion Injury

Start date: September 2009
Phase: Phase 4
Study type: Interventional

Rationale: Apart from their cholesterol lowering effects, statins have cholesterol‐independent pleiotropic actions, such as upregulation of 5'‐ectonucleotidase and up‐regulation of NO‐synthase that may increase tolerance against ischemia‐reperfusion injury (IR‐injury). Several animal studies have shown reduction of IR‐injury as a result of statin treatment in both the heart and the kidney. Recently the investigators have shown, using Annexin A5 targeting after voluntary ischemic exercise to assess IR‐injury, a protective effect of a 7 day oral rosuvastatin treatment. A three day treatment with atorvastatin however failed to reduce annexin targeting. Assessment of the flow mediated dilation of the brachial artery as measure of endothelial (dys)function, is a validated model to research effects of possible protective strategies and perform mechanistic experiments on IR‐injury in humans in vivo. The investigators hypothesize that pretreatment with statins can increase endothelial tolerance against ischemia and reperfusion injury. Objective: To study the protective effect of pretreatment (both 3 day and 7 day) with rosuvastatin and atorvastatin on flow mediated dilation after 15 minutes ischemia and 15 minutes reperfusion. Study design: placebo‐controlled randomised double‐blind trial Study population: Healthy volunteers, age 18‐50 Intervention: Treatment with either rosuvastatin 20 mg, atorvastatin 80mg or placebo during either 3 or 7 days Main study parameters: Difference in flow mediated dilation before and after 15 minutes ischemia. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Treatment with rosuvastatin or atorvastatin is not expected to harm the volunteers. Most reported side effects of rosuvastatin and atorvastatin are gastro‐intestinal complains and myalgia. The volunteers will not benefit directly from participating in this study.

NCT ID: NCT00987363 Completed - Diabetic Foot Clinical Trials

Intraarterial Infusion of Autologous Bone Marrow in Diabetic Patients With Chronic Ischemia of Lower Limbs (CLI) no Revascularization

Start date: July 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of the study is to evaluate the safety and feasibility of autologous bone marrow mononuclear cells autologous administered intra-arterially in the affected limb of diabetic patients with chronic critical ischemia of the lower limbs (CLI) without possibility of revascularization or other therapeutic alternatives. The trial hypothesis we propose consists of mononuclear cells of bone marrow providing progenitor cells with regenerative capacity and secrete also several angiogenic factors, and their implantation into ischemic tissues with both elements should contribute to angiogenesis and tissue regeneration with recovery of the circulation in the affected limb

NCT ID: NCT00987324 Completed - Heart Disease Clinical Trials

Efficacy Study of Paclitaxel-eluting Balloon, -Stent vs. Plain Angioplasty for Drug-eluting Stent Restenosis

ISAR-DESIRE-3
Start date: July 2009
Phase: Phase 4
Study type: Interventional

The purpose of this randomized study is to determine which treatment option, either paclitaxel-eluting balloon, paclitaxel-eluting stent or plain balloon angioplasty is the most effective in the treatment of restenosis after implantation of "Limus"-eluting stents, (LES).

NCT ID: NCT00981006 Completed - Clinical trials for Congestive Heart Failure

AutoLogous Human CArdiac-Derived Stem Cell to Treat Ischemic cArdiomyopathy (ALCADIA)

ALCADIA
Start date: April 2010
Phase: Phase 1
Study type: Interventional

The aim of this study is to evaluate the safety and efficacy on the transplantation of autologous human cardiac-derived stem cells (hCSCs) with the controlled release of basic fibroblast growth factor (bFGF) to severe refractory heart failure patients with chronic ischemic cardiomyopathy concordance with reduced left ventricular dysfunction (15%≦LVEF≦35%).

NCT ID: NCT00979199 Completed - Clinical trials for Ischemic Heart Disease

Evaluation of Integrated Cardiac Imaging in Ischemic Heart Disease

EVINCI
Start date: February 2009
Phase: Phase 4
Study type: Interventional

Main purpose of the study: To comparatively assess the diagnostic performance of non invasive anatomical and functional imaging modalities to detect significant obstructive coronary artery disease as demonstrated at invasive coronary angiography and functional evaluation of coronary lesions (fractional flow reserve).

NCT ID: NCT00967434 Completed - Clinical trials for Myocardial Infarction

Statin Drugs to Prevent Complications During Surgery

STAR-VaS
Start date: December 2007
Phase: N/A
Study type: Interventional

Patients undergoing non-cardiac surgery frequently experience perioperative cardiac complications that may be due to excess inflammatory reactions. Lipid lowering drugs called HMG-CoA reductase inhibitors or statins, have anti-inflammatory effects. Although favourable evidence suggests these drugs could also prevent perioperative cardiac complications, definitive evidence of anti-inflammatory effects and benefit is lacking. The purpose of this study to measure the impact of a atorvastatin on patients undergoing surgery. It will attempt to determine the speed of drug effect as measured by the impact the drug has on the levels of the inflammatory mediator called C-reactive protein after surgery. It is hypothesized that the perioperative use of atorvastatin will safely reduce the postoperative rise in CRP levels at 48 hours after elective vascular surgery. This effect, would then translate into a reduction of adverse perioperative complications including reduction in postoperative myocardial ischemia episodes (as measured through Holter monitoring).