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Ischemia clinical trials

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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: NCT01013532 Active, not recruiting - Brain Ischemia Clinical Trials

PreventIon of CArdiovascular Events in iSchemic Stroke Patients With High Risk of Cerebral HemOrrhage

PICASSO
Start date: June 2009
Phase: Phase 4
Study type: Interventional

Through this study, the investigators are to prove that Cilostazol effectively prevent cardiovascular events in ischemic stroke patients with high risk of cerebral hemorrhage, along with no significant increase in the risk of occurrence of hemorrhagic side effects. The primary hypothesis of this study is; Cilostazol alone or with probucol will reduce the risk of cerebral hemorrhage without increase of cardiovascular events compared to aspirin in the ischemic stroke patients with symptomatic or asymptomatic old cerebral hemorrhage. This study will prove the superiority of cilostazol on the prevention of cerebral hemorrhagic events without increasing the cardiovascular events against aspirin and the superiority of probucol on the prevention of overall cardiovascular events.

NCT ID: NCT01002495 Withdrawn - Myocardial Ischemia Clinical Trials

Gene Therapy for the Treatment of Chronic Stable Angina

Start date: March 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of catheter based injections of VM202 into the heart.

NCT ID: NCT00993564 Withdrawn - Clinical trials for Hypoxic Ischemic Encephalopathy

Magnetic Resonance Imaging (MRI) Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy (HIE)

Start date: September 2009
Phase: N/A
Study type: Observational

The investigators will determine if the MRI can be used to determine the temperature inside the brain. This is an important piece of information now that cooling the brain is being used to decrease brain damage in infants who had a decrease in brain oxygen or flow around the time of birth.

NCT ID: NCT00991029 Terminated - Clinical trials for Ischemic Attack, Transient

Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial

POINT
Start date: May 28, 2010
Phase: Phase 3
Study type: Interventional

A transient ischemic attack (TIA) is a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. An ischemic stroke is a cerebral infarction. In POINT, eligibility is limited to brain TIAs and to minor ischemic strokes (with an NIH Stroke Scale [NIHSS] score less than or equal to 3). TIAs are common [25], and are often harbingers of disabling strokes. Approximately 250,000-350,000 TIAs are diagnosed each year in the US. Given median survival of more than 8 years [32], there are approximately 2.4 million TIA survivors. In a national survey, one in fifteen of those over 65 years old reported a history of TIA [33], which is equivalent to a prevalence of 2.3 million in older Americans. Based on the prevalence of undiagnosed transient neurological events, the true incidence of TIA may be twice as high as the rates of diagnosis [33]. Based on our review of the National Inpatient Sample for 1997-2003, there were an average of 200,000 hospital admissions for TIA each year, with annual charges climbing quickly in the period to $2.6 billion in 2003. Composite endpoint of new ischemic vascular events: ischemic stroke, myocardial infarction or ischemic vascular death at 90 days.

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).