View clinical trials related to Ischemia.
Filter by:To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.
This pilot trial will be the first step toward direct comparison of delivery of endovascular reperfusion therapy to intravenous rt-PA in a time-to-treatment framework shown as most effective by the NINDS rt-PA Stroke Trial. A randomized trial is justified for the following reasons: 1) The high rate of death and disability associated with ischemic stroke despite treatment with intravenous rt-PA mandates critical analysis of alternate therapies with therapeutic potential, 2) endovascular treatment for acute ischemic stroke is expanding in North America without compelling evidence of safety and efficacy from well-designed clinical trials, 3) critical cost-effectiveness analysis cannot be done without acquiring pertinent outcomes data from controlled studies.
This study will assess the safety and efficacy of intra-arterial infusion and intramuscular injection of an autologous, bone marrow-derived stem cell preparation (ASCT01) in patients with critical limb ischemia who have exhausted all medical and surgical therapeutic options. The safety and tolerability will be evaluated by regular monitoring of the general physical condition, vital signs, and the occurrence of AE and SAE, respectively. Furthermore, the standard biochemical and blood variables (red and white blood cell counts, Hb, Ht, platelets, sodium, potassium, chloride, calcium, phosphor, ASAT, ALAT, bilirubin, total protein, albumin, AP, cholesterol (LDL,HDL), triglycerides, urea and creatinine, immunoglobulins, HBA1c, C-peptide) will be checked before the treatment as well as 30 and 90 days after the treatment.
This study is a French multicenter prospective study including 5 stroke units with available MRI and F-MISO PET for patients with acute ischemic stroke. Background and Purpose: 18F-Fluoromisonidazole (FMISO) PET has been used to identify hypoxic tissues in animals and stroke patients. While MRI has become the gold standard acute stroke imaging, no published study has compared FMISO PET and MRI. The aim of this prospective study is to identify hypoxic tissues in 40 patients with acute ischemic stroke with F-MISO PET and to compare the location and the outcome of these hypoxic cells with MRI datas (weighted diffusion and FLAIR) and to clinical outcome.
The goal of this study is to show the efficacy and safety of heparin and nadroparin in the acute phase of ischemic stroke. Therapeutic agents are administered at intervals of 4.5 to 2 hours after onset of clinical signs. Overall administration of anticoagulant agents will test 72 hours. Randomized patients will be divided into three groups. The first group of patients will receive heparin intravenously at the beginning of 2500 UI bolus intravenously, followed by intravenous pump 1000 UI / h (18-20 IU / kg / hr) to reach 2-2.5 times the baseline aPTT. After 24 hours, patients will receive the group Nadroparin subcutaneously in the therapeutic dose. Second group of patients will be administered subcutaneously Nadroparin the therapeutic dose as recommended. The third group of patients are those who will receive placebo intravenously and 24 hours after receiving nadroparin subcutaneously in the therapeutic dose. All patients will receive after 24 hours of starting treatment 100 mg of aspirin per orally. For initiation of treatment will be assessed: - Modified Rankin Scale, National Institutes of Health Stroke Scale, inclusion, exclusion criteria - Sign the informed consent and patient randomization - Laboratory parameters: glucose, creatinine, GGT, K, Na, Cl, blood count, basic coagulation - Women of childbearing age (pregnancy test) - History, clinical presentation, medical history, basic internal review of the status (blood pressure, pulse, body temperature, etc.). - Initial CT examination of the brain - EKG - USG sections of extracranial carotid and vertebral arteries - special hematology factors If a patient meets all the necessary criteria, he may be given the test substance. During the first 24 hours will be monitored at regular intervals vital functions. After 24 hours, each patient received subcutaneous Nadroparin the therapeutic dose and also 100 mg of aspirin per orally. In the interval from 24 to 30 hours of starting treatment the patient will be made: - Control CT brain - EKG - Basic coagulation - Reduction to stop treatment for newly identified haemorrhage or severe and extensive focal cerebral ischemia by CT scan - special hematology factors 72 hours, 7, 30 and 90 days after starting treatment, the patient's clinical evaluation using the Modified Rankin Scale, National Institutes of Health Stroke Scale and Barthel Index. Safety endpoints: mortality, adverse side effects, bleeding
This research is being done to find out the safety of the investigational study drug, Clonidine Hydrochloride ( CLON). , in infants who are undergoing whole body cooling for the treatment of hypoxic ischemic encephalopathy (HIE). The only known and effective treatment for HIE is therapeutic hypothermia or whole body cooling for72 hours. During the cooling process, babies get agitated, shiver and are uncomfortable. To treat these side effects morphine is frequently used. CLON is very effective in decreasing shivering in adults and children. Furthermore, in some preclinical studies, clonidine has been shown to be neuroprotective (safe for the brain in models of brain injury)..This is a Phase I-II to determine if low dose CLON will reduce the incidence of shivering and whether it has short term cardiovascular safety. In this Phase I-II study, the investigators will determine the (i) the maximum tolerated dose of CLON during cooling for HIE, (ii) the effects of CLON on heart rate, blood pressure, core body temperature and cerebral autoregulation (ability to maintain constant blood flow to the brain) and (iii) association between blood levels and changes in the above parameters. In this study the investigators hope to find ways to improve sedation, shivering and agitation in newborn infants with HIE on the cooling protocol. Our ultimate goal is determine the potential neuro-protective properties of clonidine in newborn babies with HIE.
Prospective randomized comparison between endovascular procedures performed with iodinated contrast or carbon dioxide as intraarterial contrast.
The aim of the study is to assess presence of myocardial ischemia by contrast stress echocardiography in patients with symptomatic non-obstructive coronary artery disease (CAD) by CT-coronary angiography, and the clinical, vascular, biochemical and genetic markers of myocardial ischemia in such patients.
Primary Endpoint: The primary objective is to show that AIS patients, ineligible for or refractory to treatment with IV-tPA, with appropriate image selection, treated with mechanical thrombectomy within 6-12 hours of symptom onset have less stroke related disability and improved good functional outcomes as compared to those treated with best MT with respect to endpoint defined as: • 90-day global disability assessed via the modified Rankin score (mRS), analyzed using raw mRS scores. Statistical details can be found in section 7.2. Secondary Endpoints: - 90-day global disability in the 6-12 hr cohort assessed via the overall distribution of mRS - Proportion of patients with good functional recovery for the 6-12 hr cohort as defined by mRS 0-2 at 90 days - Mortality at 30 and 90 days - Intracranial hemorrhage with neurological deterioration (NIHSS worsening >4) within 24 hours of randomization - Procedure related serious adverse events (SAE's) - Arterial revascularization measured by TICI 2b or 3 following device use
Stroke is a major cause of adult disability. Currently approved reperfusion therapies are provided to only a small percentage of patients in the U.S. New therapies are needed that improve outcome and that can be accessed by a majority of patients. Animal studies suggest that bone marrow-derived mesenchymal stem cells, administered intravenously days after a stroke, safely improve long-term behavioral outcome. A large human experience suggests the safety of allogeneic bone marrow-derived mesenchymal stem cells. The current study aims to assess the safety of this therapy in patients with recent ischemic stroke.