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Ischemia clinical trials

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NCT ID: NCT00783796 Terminated - Clinical trials for Coronary Artery Disease

SPIRIT Small Vessel Registry

SPIRIT SV
Start date: October 2008
Phase: N/A
Study type: Interventional

To evaluate the safety and effectiveness of the 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in improving coronary luminal diameter in subjects with ischemic heart disease due to a maximum of two de novo native coronary artery lesions in small vessels, each in a different epicardial vessel.

NCT ID: NCT00778323 Completed - Spinal Cord Injury Clinical Trials

Clinical Trial of Remote Preconditioning in Patients Undergoing Cervical Decompression Surgery

Start date: September 2007
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess whether a large clinical trial testing the effect of RIPC on neurologic outcome in patients undergoing elective cervical decompression surge is warranted.

NCT ID: NCT00777166 Completed - Myocardial Ischemia Clinical Trials

Cardiac Effects of Oxytocin Administrated During Cesarean Section, Signs of Myocardial Ischemia

Start date: December 2005
Phase: Phase 4
Study type: Interventional

Oxytocin has cardio vascular effects as hypotension, tachycardia and possibly coronary spasm. The uterotonic effect of the drug is used during cesarean section, to minimize blood loss.ECG changes suggestive of cardiac ischemia (ST depression) has been showed in previous studies of patients undergoing cesarean section i regional anaesthesia. The effect of oxytocin on this outcome has not been investigated to any extent. In the current study, we tested the hypothesis that there was no difference in occurrence of ECG changes (ST segment depression) between two doses of oxytocin. Participants were randomized to receive either 5 or 10 units of oxytocin in a double blinded fashion. Main outcome measure is occurrence of significant ST depression on ECG. Secondary outcome measures are mean arterial pressure, heart rate, blood loss, symptoms as chest pain, shortness of breath and feeling of heaviness on the chest.

NCT ID: NCT00777140 Completed - Clinical trials for Ischemic Stroke, Acute

Thrombolysis and Deferoxamine in Middle Cerebral Artery Occlusion

TANDEM-1
Start date: September 2008
Phase: Phase 2
Study type: Interventional

Iron overload has been associated with greater brain injury in ischemia/reperfusion experimental stroke models and ischemic stroke patients, especially in those treated with thrombolytic treatment. Deferoxamine administration, an iron chelator, offers a neuroprotective action in ischemia/reperfusion animal models. Primary objective: To evaluate the security and tolerability of deferoxamine endovenous treatment in acute ischemic stroke patients treated with iv. tPA. Secondary objectives: To study pharmacokinetics of deferoxamine given by endovenous bolus (10 mg/Kg) followed by 72-hour continuous intravenous infusion (20, 40 o 60 mg/Kg). To evaluate the deferoxamine effect in clinical outcome, infarct volume and hemorrhagic transformation and brain edema development. Methodology: Double-blind, randomized, placebo controlled, dose-finding phase II clinical trial. Study stages: 1st: bolus+20 mg/Kg/day vs. Placebo (n=15:5); 2nd: bolus+40 mg/Kg/day vs. Placebo (n=15:5); 3rd: bolus+60 mg/Kg/day vs placebo (n=15:5). These doses will be increased according to security results of the previous stage. Patients will be continuously monitored in stroke units. Laboratory parameters will be measured at baseline, 24h, 72h and 30 days to evaluate adverse events related to the drug. Serum deferoxamine and feroxamine concentrations will be measured along time after the injection in a subgroup of patients to the pharmacokinetics study. CT scan will be performed at 24-36h to assess hemorrhagic transformation and brain edema. The NIH Stroke Scale will be evaluated during hospitalization, and the Rankin score at discharge and 3 months. If deferoxamine demonstrate to be secure and well tolerated treatment in acute stroke patients, it may be a new therapy option to lower the brain injury after ischemia and reperfusion.

NCT ID: NCT00774891 Withdrawn - Ischemia Clinical Trials

Comparison Of Left Ventricular Volume And Wall Stress With Dobutamine And Exercise Echocardiography

Start date: October 2008
Phase: N/A
Study type: Observational

This study will compare the physiologic responses between exercise stress echocardiography and pharmacologic stress echocardiography on left ventricular volume and wall stress.

NCT ID: NCT00769275 Completed - Clinical trials for Type 2 Diabetes Mellitus

Detection of Ischemia in Asymptomatic Diabetics

DIAD
Start date: August 2000
Phase: N/A
Study type: Observational

Asymptomatic subjects with Type 2 Diabetes Mellitus were randomized to either screening with Tc-99m sestamibi adenosine SPECT imaging or no screening. All patients will be followed for 5 years for the occurrence of cardiac death or non-fatal myocardial infarction. The aims are: 1. To prospectively assess the prevalence of silent myocardial ischemia in asymptomatic subjects with Type 2 Diabetes Mellitus. 2. To identify on the basis of clinical and/or biochemical variables in a high-risk cohort in which screening for coronary artery disease is appropriate. 3. To assess progression of (silent) myocardial ischemia after 3 years. 4. To assess the occurence of cardiac death or nonfatal myocardial infarction during 5 years follow-up in screened and not screened subjects.

NCT ID: NCT00768495 Recruiting - Clinical trials for Chronic Limb Ischemia

Hyperspectral Imaging Pre and Post Endovascular Intervention

CLI-Pre/Post
Start date: October 2008
Phase: N/A
Study type: Observational

This trial will collect tissue oxygenation data via hyperspectral imaging before and after endovascular procedures.

NCT ID: NCT00766896 Completed - Stroke Clinical Trials

Platelet Hyperreactivity to Aspirin and Stroke

PLARAS
Start date: July 2009
Phase: Phase 4
Study type: Interventional

STUDY QUESTIONS - What is the real prevalence of platelet "resistance" to aspirin during the acute phase of stroke and after 3 months, and 1 year, as measured using different platelet function tests? - Do all methods measure similar levels of resistance, or are some methods more sensitive than others? - Does this resistance result in a worse clinical prognosis? Is this result independent of other variables? OBJECTIVES 1. Hospital Phase (Acute Stroke) - Determination, using various methods, of the prevalence of platelet hyperreactivity in patients treated with aspirin to treat ischemic stroke (acute phase) - Comparison of different assessment methods and identification of the most accurate of these - Identification of variables that correlate with platelet hyperreactivity 2. Follow-up Phase - Correlation between platelet hyperreactivity and important clinical outcomes at 12, 24, and 36 months - Correlation between platelet hyperreactivity and death or dependency at hospital discharge, at 3, 12, 24, and 36 months (Modified Rankin Scale) - Correlation between platelet hyperreactivity and recurrent stroke of any type - Correlation between different methods for evaluating platelet functions and identification of the most accurate method - Analysis of hyperreactivity over time THE STUDY - The study will include 200 consecutive patients seen in the emergency department of a large, urban hospital (1500 inpatient beds) and diagnosed with stroke in the acute phase; these patients will be treated with aspirin for an undetermined period - The investigators will not include patients who require full anticoagulation treatment, regardless of the cause - Importantly, the analysis of primary and secondary outcomes will be carried out after blinding the examiner to the results of the platelet aggregation tests PLATELET TESTS - Whole Blood Aggregometer, ChronoLog - VerifyNow, Accumetrics - PFA-100, Siemens - Plateletworks, Helena - Impact-R, Diamed - Serum thromboxane B2

NCT ID: NCT00765050 Terminated - Clinical trials for Diabetic Patients With Critic Ischemia in Lower Limbs Who Are Administered With CD133+ Cells Mobilized by G-CSF

A Prospective, Open, Non-randomized Phase I/II Study of Therapeutic Angiogenesis in Diabetic Patients With Critic Ischemia of Lower Limbs While Administering Positive CD133 Mobilized With G-CSF

Start date: January 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective is to analyze the safety and efficacy of CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs. The secondary objectives are: - To determine the safety of the intramuscular administration of CD133+ cells that have been mobilized from peripheral blood. - To determine the CD133+ capacity to increase the re-vascularization at lower limbs in diabetic patients with critic ischemia in the lower limbs. - To evaluate the patient global health condition using the notified results of the SF-36 questionnaires completed by patients

NCT ID: NCT00762333 Recruiting - Clinical trials for Myocardial Infarction

Circulating Markers for Ischemic Heart Disease

Start date: June 2007
Phase:
Study type: Observational

The purpose of this research is to determine if two proteins in the blood are increased during acute myocardial infarction and whether their levels are higher in those who develop heart failure than those who do not. These two proteins are produced and potentially released when the heart muscle is damaged. They may then be released into the blood and be detected by standard method in the research laboratory. At this time, detection of an increase in these proteins in the blood is not known to be associated with any disease or myocardial infarction.