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Ischemia clinical trials

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NCT ID: NCT01670981 Completed - Clinical trials for Ischemic Dilated Cardiomyopathy (IDCM)

An Efficacy, Safety and Tolerability Study of Ixmyelocel-T Administered Via Transendocardial Catheter-based Injections to Subjects With Heart Failure Due to Ischemic Dilated Cardiomyopathy (IDCM)

ixCELLDCM
Start date: February 20, 2013
Phase: Phase 2
Study type: Interventional

This study is designed to assess the efficacy, safety and tolerability of ixmyelocel-T compared to placebo (vehicle control) when administered via transendocardial catheter-based injections to patients with end stage heart failure due to IDCM, who have no reasonable revascularization options (either surgical or percutaneous interventional) likely to provide clinical benefit.

NCT ID: NCT01667016 Completed - Clinical trials for Coronary Artery Disease

BIOFLOW-III Austria Satellite Registry

Start date: August 2012
Phase: N/A
Study type: Observational

This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

NCT ID: NCT01667003 Completed - Clinical trials for Coronary Artery Disease

BIOFLOW-III Sweden Satellite Registry

Start date: August 2012
Phase: N/A
Study type: Observational

This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

NCT ID: NCT01666587 Completed - Clinical trials for Ischemic Reperfusion Injury

Ischemia Reperfusion: Prostaglandins and Antioxidants

Start date: August 2012
Phase: N/A
Study type: Interventional

The purposes of this study are two-fold. The first purpose is to determine the effect of taking vitamins on the recovery of an artery (blood vessel) following an induced temporary injury. The second purpose is to determine whether a specific vasodilator is less abundant after the injury and whether this contributes to increased constriction or after the injury. Finally, does vitamin consumption have an effect on the recovery from the injury if one of the substances in the blood that causes vessels to enlarge (dilate) is stopped?

NCT ID: NCT01666132 Terminated - Clinical trials for Chronic Ischemic Heart Disease

METHOD - Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease

Start date: January 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Intramyocardial, NOGA guided injection of bone marrow derived mononuclear cells in patients with chronic ischemic heart disease and LVEF < 40%. The primary objective is to determine whether the administration of the cells improves recovery of the left ventricular function. Secondary objective is the finding of clinical or paraclinical parameters to predict potential benefits of the treatment (basing on MRI characteristics such as size, transmurality of the myocardial infarction and peri-lesional ischemia). In the first part of the study 10 patients are treated without control group. This phase serves as feasibility and safety part of the study.

NCT ID: NCT01666093 Recruiting - Clinical trials for Peripheral Artery Disease Without Critical Limb Ischemia

Non-Healing Ulcers Without Critical Limb Ischemia

NEWLI
Start date: August 2012
Phase: Phase 2
Study type: Interventional

Background: Lower limb arterial revascularization procedures, either percutaneously or surgically performed, are an established treatment modality of ischemic foot ulcers, especially in the setting of a critical limb ischemia. Many other lower limb ulcers are secondary to a combined disease, which may include a concomitant venous disease (chronic venous insufficiency or varicous disease) or a micro-angiopathic disease (i.e. small vessel disease). In this setting, and especially in the absence of a concomitant severe macro-angiopathic disease, the safety and efficacy of a percutaneous lower limb revascularization have so far never been evaluated in a prospective study. Aim: This study is aimed to evaluate the safety and the efficacy of an endovascular revascularization approach of the lower limb, in all consecutive patients presenting with a non-healing ulcer associated with a mild to moderate peripheral artery disease (i.e. mixed-origin ulcers). Material and methods: This prospective study will consecutively include all patients presenting with a non-healing ulcer. Included patients must have all the concomitant ulcer co-factors being adequately treated for at least 6 months. Accordingly, an underlying venous disease, infectious disease or inflammatory disorder must be previously evaluated and adequately treated (i.e. compression stocking, varices stripping, antibiotics, local ± systemic anti-inflammatory, etc.). Furthermore, a non-invasive arterial evaluation must be obtained in all patients. The arterial screening must included an ankle-brachial index (ABI) and toe pressure (TP) measurements, a trans-cutaneous oxygen measurement (tcPO2) at the foot and calf levels and a non-invasive arterial mapping (i.e. angio-CT or angio-MRI). This arterial work-up must be compatible with the presence of a mild to moderate peripheral artery disease without any sign or criteria suggesting the presence of a critical limb ischemia. End-points: The success rate of perform an endovascular revascularization intervention in all consecutive patients which qualify according to the inclusion criteria (technical feasibility). Establish the proportion of procedural related complications (safety). Analyze the clinical and the para-clinical improvements in term of heal of the ulcers, as well as the improvement of the ABI, TP, tcPO2 at 1 week, 1-3-6 months after the procedure (efficacy). Sample size: The investigators plan to include ≈ 30 patients in two years. After 1 year of enrollment the investigators will perform an interim analysis and will decide at that moment, according to the observed end-points, if prolonging the study would be of any scientific value or if the study has to be interrupt earlier because of a significant improvement of all already treated ulcers.

NCT ID: NCT01665885 Active, not recruiting - Ischemic Stroke Clinical Trials

Hypothermia in Acute Ischemic Stroke - Surface Versus Endovascular Cooling (HAIS-SE)

HAIS-SE
Start date: August 2012
Phase: Phase 2
Study type: Interventional

HAIS-SE is evaluating for the first time ever in a randomized controlled trial efficacy, tolerability, practicability and safety of endovascular versus surface cooling in awake stroke patients.

NCT ID: NCT01665729 Recruiting - Ischaemic Stroke Clinical Trials

Diagnosis and Treatment of Minor Ischaemic Stroke According to the Etiology and Pathogenesis

Start date: June 2011
Phase: N/A
Study type: Observational

Negligence or contempt of the etiology and pathogenesis of minor ischaemic stroke in the early diagnosis and effective treatment leads to more than 40-50% of patient with recurrent episodes, and 10% patient died. Therefore, diagnosis and treatment of minor ischaemic stroke according to the etiology and pathogenesis is important. The 2007 Korean modified TOAST type got some progress, but there exists two major disadvantages: imperfect diagnosis and pathogenesis of perforator artery infarction etiology; lack of typing according to the pathogenesis of large atherosclerotic infarction and taking measures of treatment according to the new types. Recently, domestic professor Gaoshan proposes new approach to diagnose and treat minor ischaemic stroke according to the etiology and pathogenesis of CISS typing, but the pathogenesis of hypoperfusion infarction with severe stenosis of large artery is unclear. Is it low perfusion? Or artery-artery embolization? Or both? How to distinguish the pathogenesis of branch artery disease: by atherosclerosis? Or hyalinosis? Or both? How to check the validity of clinical types? This study take different interventions according to different types and observation of the long term clinical results of intervention( mortality, recurrence rate, disability rate and rate of cerebral hemorrhage and subarachnoid hemorrhage), in order to clarify the new types can indeed solve the current problem of minor ischaemic stroke with high mortality, recurrence rate, disability rate and rate of cerebral hemorrhage and subarachnoid hemorrhage.

NCT ID: NCT01663376 Completed - Clinical trials for Critical Limb Ischemia

Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cells Implantation in Patients With Critical Limb Ischemia

Start date: January 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with critical limb ischemia

NCT ID: NCT01661582 Completed - Clinical trials for Coronary Heart Disease

Myocardial Ischaemia After Exposure to Diesel Exhaust

MIDAS
Start date: September 20, 2012
Phase: N/A
Study type: Interventional

Exposure to particulate air pollution is associated with increases in cardiovascular mortality and morbidity. The pathophysiological mechanisms underlying this observation are emerging, and exposure to particulate air pollution has been shown to result in increases in blood pressure and arterial tone, impaired vascular function and an increased tendency for blood to clot as well as an increase in atherosclerotic plaque burden. Recent evidence from panel studies and controlled exposure studies have suggested an increase in myocardial ischaemia (a reduction in blood flow to the heart) following exposure. In this study we aim to investigate directly myocardial (heart) blood flow following exposure to diesel exhaust (as a model of urban air pollution) using CT/PET myocardial perfusion imaging in male patients with stable coronary disease and healthy male controls. We hypothesize that following exposure to dilute diesel exhaust: 1. Myocardial blood flow will be reduced 2. Coronary flow reserve will be impaired 3. The magnitude of impairment will be higher in patients with coronary disease as compared to healthy controls