SWiss Multicenter Intracoronary Stem Cells Study in Acute Myocardial Infarction (SWISS-AMI)

Overview

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.