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Ischemia clinical trials

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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: 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: NCT00883467 Active, not recruiting - Ischemia Clinical Trials

The Effects of Preconditioning on Intramuscular High-Energy Phosphate Levels During Ischemia

IPC in MRI
Start date: May 2008
Phase: N/A
Study type: Interventional

Ischemia reperfusion injury may be reduced by ischemic preconditioning. This projects aims to show the effects of short and long time ischemic preconditioning (both sequences 3 x 5 minutes) during and after an ischemic period of 20 minutes in healthy subjects by functional MRI. Ischemia is produces by cuff inflation to a suprasystolic pressure on one tight. Signal is acquired from calf muscles. A cross-over design of 4 to 8 study periods is used, 4 different study days with 2 different MR measurement methods (BOLD imaging and high energy phosphates) are planned.

NCT ID: NCT00876668 Active, not recruiting - Clinical trials for Peripheral Vascular Disease

Evaluation of the Clinical Significance of Fluorescence Videoangiography With Indocyanine-Green

Start date: June 2007
Phase: N/A
Study type: Observational

The aim of the study is to compare the diagnostic value of this non-invasive vascular imaging tool with the established vascular diagnostic methods for PAD in order to get prognostic data. A higher sensitivity of Fluorescence angiography in order to recognize progression of critical limb ischemia could lead to earlier therapeutic interventions and thereby increase limb salvage. A diagnostic gap would be closed.

NCT ID: NCT00846924 Active, not recruiting - Stroke Clinical Trials

30-Day Cardiac Event Monitor Belt for Recording Atrial Fibrillation After a Cerebral Ischemic Event

EMBRACE
Start date: May 2009
Phase: N/A
Study type: Interventional

Atrial fibrillation is the most common cardiac cause of ischemic stroke. Detecting atrial fibrillation after a stroke or TIA is critical because highly effective secondary stroke prevention therapy is available for individuals who are recognized to have atrial fibrillation. However, atrial fibrillation is likely under-diagnosed after stroke and TIA because atrial fibrillation is often difficult to detect as it is frequently paroxysmal and asymptomatic, and patients do not routinely undergo prolonged screening. The purpose of this study is to determine the diagnostic yield of a novel 30-day cardiac event monitor compared to a repeat 24-hour Holter monitor for detecting occult paroxysmal atrial fibrillation in patients with a recent ischemic stroke or TIA of undetermined etiology after completion of a standard clinical stroke work-up (including an initial negative Holter monitor.)

NCT ID: NCT00832702 Active, not recruiting - Clinical trials for Cardiovascular Disease

Women's Ischemia Syndrome Evaluation (WISE) Coronary Vascular Dysfunction

Start date: September 17, 2008
Phase:
Study type: Observational

This research study is designed to investigate the approaches to noninvasive detection and assessment of coronary vascular dysfunction in women by comparing the testing results from the invasive standard care diagnostic procedure Angiogram and from the additional noninvasive diagnostic procedure CMR Imaging. The investigators want to specifically study 375 female patients who have signs or symptoms suggestive of heart disease but don't have obstructive coronary artery disease. Two study sites (Cedars-Sinai Medical Center and University of Florida) are recruiting participants. The standard of care procedures include demographics, review of recent clinical symptoms, review of medications being taken, a physical exam, pre-angiogram blood collection, chest x-ray, ECG and heart angiogram. The research procedures for this study are the cold pressor testing, blood/urine collection, health questionnaire, the post-angiogram ECG and cardiac MRI. Patients will be asked to undergo heart angiogram testing to test for abnormalities in their heart arteries. If the heart angiogram shows that the patients do not have blockages in major heart arteries, then the patients will have coronary flow reserve measurement test (as part of the heart angiogram) to determine whether the patients have abnormally functioning of the small heart arteries. This test will be performed by infusing the three drugs: adenosine, acetylcholine and nitroglycerin. The three drugs are naturally occurring substances and have been used for routine heart angiograms. Cardiac Magnetic Resonance (CMR) imaging may help us more easily and non-invasively detect abnormalities in the inner layer of the heart muscle resulting from the abnormal function of the heart arteries. All the 375 participants will undergo baseline CMR imaging test and a subgroup of 200 participants will undergo a second CMR imaging test at their at least 1-year followup visit. Patients will be followed up using phone questionnaires at 6 weeks, 6 months for 5 years, and than annually for 20 years thereafter. Other procedures in this study include obtaining informed consent, review of demographics, physical examination, ECG, blood and urine tests, clinical symptoms, medications, questionnaires, etc. The core laboratories include Blood, Lipoprotein, Chemistry Core Lab, Reproductive Hormone Core Lab, Inflammatory Marker Core Lab, Oxidative Stress Core Lab, and Angiographic Core Lab. Additionally, GCRC at Cedars Sinai will process, store and ship samples as needed/required.

NCT ID: NCT00791206 Active, not recruiting - Ischemia Clinical Trials

Trial of the Effects of Remote Preconditioning on the Tissue Metabolism During Exercise and Ischemia

Start date: November 2008
Phase: Phase 2
Study type: Interventional

Previously, the preconditioning signaling pathways have been studied on molecular level or in animal model. By using MR spectroscopy and imaging in a dynamic human model of preconditioning, we will have a better understanding how mitochondrial and endothelial function are affected by preconditioning in-vivo.

NCT ID: NCT00642213 Active, not recruiting - Ischemic Stroke Clinical Trials

A Comparison of Hemorrhagic and Ischemic Strokes Among Blacks and Whites

GCNKSS
Start date: July 1993
Phase:
Study type: Observational

Our primary goal is to study temporal trends in the incidence rate, causes, treatment, and outcome of stroke among a large biracial metropolitan population of 1,349,351, of whom 215,611 (15%) are black (2000 Census). Such data are critical for the planning, intervention, and evaluation of public health efforts to decrease the mortality and morbidity due to stroke in the United States. We have completed this goal for 1993-94, 1999, 2005, 2010 and 2015. We are in the process of collecting this data for 2020. In the 2020 study period we will also be ascertaining 3 year recurrence rates for all incident stroke events.

NCT ID: NCT00471289 Active, not recruiting - Clinical trials for Peripheral Vascular Disease

PTA and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia

PADI
Start date: August 2007
Phase: Phase 2/Phase 3
Study type: Interventional

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).

NCT ID: NCT00434616 Active, not recruiting - Diabetic Foot Clinical Trials

Autologous Bone Marrow Stem Cell Transplantation for Critical, Limb-threatening Ischemia

BONMOT
Start date: April 2007
Phase: Phase 2/Phase 3
Study type: Interventional

Critical limb ischemia is a condition where the blood circulation in the limbs, in most cases the legs, is decreased so that pain and non healing wounds ensue. Mostly, this is a sequel of arteriosclerosis and/or diabetes. If surgical and other methods for the improvement of blood supply for the leg have failed or are not possible, most of these patients will proceed to amputation of the leg. Bone marrow contains cells which can induce and augment the growth of new, small arteries called collateral arteries. It has been shown in animals and in some case series that the transplantation of a concentrate of the patient's own bone marrow with stem cells into the ischemic limb can improve the blood circulation via the induction of collateral growth. However, it is not known if this bone-marrow stem cell induced collateral growth is sufficient to avoid otherwise necessary amputations. Therefore, we conduct a study to compare the efficiency of concentrated bone marrow cells injected into the critically ischemic limb compared to a placebo procedure where only saline is injected. We think that the transplantation of autologous bone marrow will reduce the number of necessary leg amputations, reduce pain and induce wound healing. In this investigation, patients with limb threatening ischemia are randomly allocated either to the bone marrow group or to the placebo group. Patients in the bone marrow group will have their bone marrow harvested under sedation, and the bone marrow cells are concentrated. The cell concentrate will then be injected directly into the muscle of the diseased leg. Patients in the placebo group will undergo sedation as well but no bone marrow harvest is done, and saline is injected into the ischemic leg. The procedure will require about 1.5-2 hours, and the subjects will be admitted to a participating vascular Centre. Monthly examinations up to three months after the bone-marrow or placebo procedure are done. After the follow-up of three months, the rate of death and amputations and the wound healing process are compared between groups. Adverse and serious adverse events will be recorded during this time period. Diagnostic studies will be obtained to measure blood flow in the treated leg during the follow up period and include skin oxygen measurements, pressure recordings in the leg and arteriography. Also, quality of life, pain and wound healing will be assessed. After completion of the three months study participation, subjects who have been treated with placebo will be able to receive open-label bone marrow transplantation therapy.