Active clinical trials for "Myocardial Infarction"

The objective of this international, multicenter, randomized study is to assess whether coronary artery stenting is associated with a reduced infarct size in patients with AMI presenting between 12 and 48 hours after onset of symptoms compared to medical treatment alone

This is a multicenter, randomized and open-label Phase II study to compare the safety, tolerability and biological effectiveness of ALX-0081 versus the GPIIb/IIIa inhibitor ReoPro® in high risk PCI patients. Patients will receive standard treatment with acetylsalicylic acid (ASA) plus clopidogrel and heparin. Eligible patients will be randomly assigned to receive open-label study treatment with either ALX-0081 or ReoPro®. Patients will be stratified according to PCI type (elective or ad-hoc) and stent type (bare metal stent or drug eluting stent).

Study objectives: To assess the effects of postconditioning on infarct size in patients with ST-elevation infarction referred to PCI. Study design: Prospective, randomized, open-label study with blinded endpoint evaluation. Included patients will be randomly allocated to postconditioning or control. Patients with symptoms of acute myocardial infarction of less than 6 hours duration fulfilling ECG criteria for primary PCI are eligible. PCI follow established routines. In postconditioning patients, additional, short (1 min), intermittent balloon occlusions will be applied after initial opening of infarct related artery. After this intervention, PCI proceeds routinely with stent implantation. In the control group, stent implantation after initial opening proceeds as usual. Primary endpoint is final infarct size, determined by MRI after 4 months. 260 patients will be included. Follow-up is 1 year. Inclusion period: 18 - 24 months. Clinical implications: Reperfusion therapy, administered as early as possible after start of symptoms, has improved the prognosis in acute ST-elevation myocardial infarction. Still, however, many patients suffer large infarctions, subsequently with an increased risk of heart failure, arrhythmias, and death. In pilot studies, mechanical postconditioning has been shown to reduce infarct size and thus potentially improve prognosis. However, the effect of postconditioning must be confirmed in larger clinical trials before implemented in routine treatment.

This clinical trial aims to find out the safety and efficacy of adult mesenchymal stem cells in patients with myocardial infarction.

Primary objective: To evaluate safety and tolerability, adverse events (AEs), vital signs, ECG, bleeding time, evaluation of antibody titer and safety laboratory tests Secondary objectives: To evaluate the pharmacokinetics and pharmacodynamics (platelet aggregation)of six ascending single intravenous doses of PR-15 in healthy volunteers

The conceptual hypothesis of this study is that, in patients with acute myocardial infarction and ST-segment elevation, the strategy of performing coronary angioplasty of the culprit artery with paclitaxel eluting stent significantly reduces the rate of restenosis in comparison with bare stents. The conceptual hypothesis of this study is that, in patients with acute myocardial infarction and ST-segment elevation, the strategy of performing coronary stent-angioplasty of the culprit artery under the protection of tirofiban 120 minutes after fibrinolytic significantly improves epicardial and myocardial infusion in comparison with the strategy of performing immediate intravenous thrombolysis (tenecteplase plus enoxaparine) followed by coronary angiography and adequate revascularization.

Standard treatment of patients with acute ST-segment elevation myocardial infarction consist of acute re-opening of the occluded coronary artery (primary PCI). Despite successful treatment of the epicardial vessel reperfusion is sometimes inadequate leading to large final infarct sizes. This phenomenon is known as the reperfusion injury. Several animal studies have indicated that graded re-opening of the artery may limit tissue damage. Generally this is referred to as mechanical postconditioning. The study investigates the effect on final infarct size evaluated by magnetic resonance scan of postconditioning of ST-segment elevation myocardial infarctions. Mechanical postconditioning is performed by means of several balloon inflations in the injured vessel following its acute re-opening.

The elective("standard of care") treatment of ST - elevation acute myocardial infarction (STEMI) currently consists of primary angioplasty with stent implantation during administration of Abciximab, a inhibitor of GP IIb/IIIa platelet receptor. Tirofiban is another potent inhibitor of GP IIb/IIIa platelet receptor with an efficacy on platelet aggregation inhibition equal to or greater than Abciximab if a high dose bolus is used, i.e. 25 microg/kg, (platelet aggregation inhibition > 90% 15 minutes after infusion). It can therefore be hypothesized that this drug can improve the results of primary angioplasty to the same extent as Abciximab. The aim of this study is to compare the efficacy, in terms of myocardial reperfusion indices, of Abciximab and high dose of Tirofiban in primary angioplasty for STEMI, both in the case of treatment before transfer and of treatment in the catheterization laboratory during the procedure. The reference hypothesis for the study objective is the equivalence or the non-inferiority of Tirofiban with respect to Abciximab.

Title: SWiss multicenter Intracoronary Stem cells Study in Acute Myocardial Infarction (SWISS-AMI). Study population: Patients with acute myocardial infarction, treated with primary PCI. Objective: To determine whether intracoronary infusion of BMCs improves recovery of left ventricular function after acute myocardial infarction treated by PCI Design: Multi-center, randomized, controlled clinical trial with central core lab analysis for MRI. Therapy: Intracoronary infusion of BMCs in the infarct related artery at 5-7 days or 3-4 weeks after successful primary PCI Primary Endpoint: Change in global left ventricular ejection fraction (LVEF) at 4 months relative to baseline measured by quantitative MRI. Secondary Endpoints: Change in LVEF at MRI at 12 months Change in regional left ventricular wall motion and thickness at 4 and 12 months. Change in infarct size at 4 and 12 months as assessed by "delayed enhancement" technique by MRI Analysis of the myocardial infarct size and transmurality, time to PCI and coronary flow characteristics after PCI as predictor of LV remodeling and change after cell therapy Change in myocardial perfusion at 4 and 12 months Change in serum level of amino-terminal pro-brain natriuretic peptide (NT pro-BNP) Major adverse cardiac events (MACE: death, myocardial infarction, TVR (ACBP or PCI, stroke, hospitalization for cardiac reasons) at 12 months Interventions: Aspiration of 50 ml bone marrow (<24 hours) prior to administration Intracoronary balloon-based infusion of 10 ml BMCs Cardiac MRI at baseline (resp. at hospital discharge), at 4 and 12 months Therapy groups: Bone marrow-derived stem cells infusion in the successfully revascularized infarct related vessel at day 5-7 or day 21-28. Control group: Management according to the "state of the art" medical therapy after successful primary PCI. Safety: A study independent "safety committee" will analyze the clinical results after the first 60 patients.

The purpose of this study is to determine whether erythropoietin is superior to placebo with respect to left ventricular ejection fraction in patients with ST-elevation myocardial infarction undergoing percutaneous coronary intervention.