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Ischemia clinical trials

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NCT ID: NCT00526474 Completed - Clinical trials for Myocardial Infarction

Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Patients With Atherosclerosis (TRA 2°P - TIMI 50) (P04737)

Start date: September 1, 2007
Phase: Phase 3
Study type: Interventional

The study is designed to determine whether vorapaxar, when added to the existing standard of care (SOC) for preventing heart attack and stroke (eg, aspirin, clopidogrel) in participants with a known history of atherosclerosis, will yield additional benefit over the existing standard of care without vorapaxar in preventing heart attack and stroke. The study is also designed to assess risk of bleeding with vorapaxar added to the standard of care versus the standard of care alone.

NCT ID: NCT00523731 Completed - Clinical trials for Peripheral Arterial Disease

ACPs in Severe PAD/CLI by Direct Intramuscular Injection

Start date: January 2006
Phase: Phase 1
Study type: Interventional

Study title: A Study of Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients with Critical Limb Ischemia ( ACPs-CLI ) Principle Investigator: Assoc.Prof. Pramook Mutirangura,M.D. Head of Division of Vascular Surgery , Department of Surgery, Faculty of Medicine Siriraj Hospital , Mahidol University, BKK,Thailand Study objective : To determine the safety and efficacy of intramuscular injection of blood-borne autologous ACPs in relieving symptoms of critical limb ischemia of patients treated with maximal medical therapy and don't have intravascular or operative revascularization option. Study Design : A pilot study , a single center, a non-randomized, open-label trial. Total expected no. of patients : 6 main selection criteria : A. Subjects will have one or more clinical indications diagnostic of CLI such as: distal extremity pain at rest that requires the subject to use analgesics for >2 weeks; or peripheral ischemic ulcer(s); or areas of gangrene ; or non-healing ischemic ulcers AND B. Subjects will have one or more of the following hemodynamic indicators of severe peripheral arterial occlusive disease: I. Ankle brachial index < 0.45 II. Toe brachial index < 0.35 III. TcPO2 / TcO2 of < 40 mmHg. C. The subject is a poor candidate for standard revascularization treatment for peripheral arterial disease, based on inadequate bypass conduit, or unfavorable anatomy D. Age 18 to 80 years Investigational Product : At D-8 250 ml of blood drawn from the patients for production of autologous EPCs or ACPs (VescellTM). On D0 ,at least 1.5 million ACPs with viability >75 % suspended in 30 ml sterile cell culture medium will be injected 1.5 cm deep and 1.5 apart by a 23 -gauge needle into the gastrocnemius muscle of the leg chosen (ischemic leg) for treatment. For injection planning a grid of 10X10 cm will be prepared and in each point 1 ml of ACPs suspension will be injected. The study consists of 4 periods: Screening ( D-14 to-9& D-8,Treatment(D0),Acute Safety follow-up (D1&D2),Chronic follow-up (D30 & D90)period ,total follow-up of each case is 3 months. Evaluation criteria : Safety : no.& duration of adverse event & serious adverse event Efficacy :Attenuate CLI patients symptoms (Rest pain,Pain-free walking distance,Ulcer size &Gangrene dimension and intensity)

NCT ID: NCT00518934 Recruiting - Ischemia Clinical Trials

Study for Safety and Efficiency of Therapeutic Angiogenesis for Patients With Limb Ischemia by Transplantation of Human Cord Blood Mononuclear Cell

Start date: n/a
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to analyze the safety and efficiency of therapeutic angiogenesis for patients with limb ischemia by transplantation of human cord blood mononuclear cells.

NCT ID: NCT00518401 Completed - Clinical trials for Critical Limb Ischemia

Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia

mesendo
Start date: June 2007
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to determine if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in the severely diseased ischemic limb (leg). In this study the safe use of this combination of stem cells and its effects on making new blood vessels will be evaluated. Limb Ischemia (LI) is a severe obstruction of the arteries which seriously decreases blood flow to the extremities (mainly feet and legs) and has progressed to the point of severe pain and even skin ulcers or sores. LI needs comprehensive treatment since the condition will not improve on its own. The overall goal of treatment is to reduce the pain and increase blood flow to improve symptoms or save the leg or feet. In many cases, current options for treatment including medications, surgery or endovascular procedures have not been successful. In the last few years, investigators have explored therapies aimed to increase blood flow to the ischemic vessels by transplanting cells that will promote the development of new vessels in the diseased leg. The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriate blood supply to the leg. Patients eligible to participate in this study are those suffering from poor circulation or severe leg blockages, which are not candidates for surgical procedures. Once the mixture of stem cells is prepared and the patient's bone marrow is ready, cells will be transplanted into the calf muscle of the diseased leg. Clinical studies to evaluate if the transplant works and is safe will be performed up to 1 year after cell transplant.

NCT ID: NCT00507806 Terminated - Clinical trials for Acute Ischemic Stroke

Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

Start date: March 2005
Phase: Phase 1/Phase 2
Study type: Interventional

The study is designed to examine the safety, tolerability, and activity of a combination of microbubbles (perflutren lipid microsphere [Definity®]) and continuous monitoring with 2 MHz transcranial Doppler ultrasound (TCD) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.

NCT ID: NCT00504842 Terminated - Clinical trials for Acute Ischemic Stroke

Transcranial Ultrasound in Clinical SONothrombolysis

TUCSON
Start date: December 2006
Phase: Phase 1/Phase 2
Study type: Interventional

This is a randomized, placebo controlled, parallel group dose escalation trial to evaluate the safety, tolerability, and activity of four sequential dose tiers of MRX-801 and ultrasound as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.

NCT ID: NCT00498069 Completed - Ischemia Clinical Trials

Study of Autologous Bone Marrow Concentrate for the Treatment of Critical Limb Ischemia (CLI)

Start date: November 2007
Phase: N/A
Study type: Interventional

Injections of concentrated bone marrow mononuclear cells into ischemic tissues will result in vasculogenesis

NCT ID: NCT00489827 Completed - Clinical trials for Coronary Artery Disease

Glutamate for Metabolic Intervention in Coronary Surgery

GLUTAMICS
Start date: October 2005
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to determine whether intravenous glutamate infusion given in association with surgery for unstable coronary artery disease can protect the heart from myocardial injury, postoperative heart failure and death.

NCT ID: NCT00488020 Unknown status - Clinical trials for Critical Limb Ischemia

Stem Cells for Treating Critical Ischemia

Start date: April 2006
Phase: Phase 1
Study type: Interventional

Collection of bone marrow blood Selection of mononuclear cells dilution with albumin injection into the calf muscles through 40 shots

NCT ID: NCT00484549 Completed - Clinical trials for Ischemic Stroke Hospitalized

Fabry : National Initiative of Screening

FIND
Start date: March 2007
Phase: N/A
Study type: Interventional

Fabry disease is a genetic disease due to an enzymatic deficit. A screening of this disease allows patients to benefit from an enzyme replacement therapy and prevent the occurrence of life threatening manifestations such as an ischemic stroke. The purpose of the study is to determinate the prevalence of Fabry disease in a population of male patients hospitalized for an ischemic stroke. This study, with a screening of Fabry disease, allows the patients to make a precise diagnosis of their ischemic stroke and to facilitate the screening of the other members at the facility.