Intracoronary Stem Cells in Large Myocardial Infarction

Phase 2

• Conditions: Myocardial Infarction

• Registration Number: NCT00389545
• Lead Sponsor: Charles University, Czech Republic

Brief Summary

Despite the widespread use of effective reperfusion therapies, the patients presenting late with large myocardial infarction have poor outcomes. The aim of the study was to investigate the safety and efficacy of intracoronary injection of autologous bone marrow-derived mononuclear cells (BMNCs) in patients with large myocardial infarction

Detailed Description

In the current era, up to 30% of patients with ST-segment elevation myocardial infarction, usually those presenting late, show ongoing left ventricular (LV) remodeling and poor clinical outcome despite primary percutaneous coronary intervention (PCI). Cardiac transfer of bone marrow-derived stem and progenitor cells has been investigated as an adjunctive therapy to promote regeneration of infarcted myocardium. Therefore, we designed a multicenter, randomized study to test the safety and efficacy of intracoronary injection of autologous BMNCs in patients with large acute anterior myocardial infarction and late presentation, who were treated with successful primary PCI.

Study Timeline

• Status Verified: 2006-10
• Study First Submitted: 2006-10-18
• Study First Submitted QC: 2006-10-18
• Last Update Submitted: 2006-10-18
• Study First Posted: 2006-10-19
• Last Update Posted: 2006-10-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with the first ST-segment elevation acute anterior myocardial infarction due to occlusion of the proximal left anterior ascending coronary artery (LAD), who will underwent successful primary stented PCI. Patients are eligible if they have primary PCI from 4 to 12 hours after symptoms onset and show reduced LV ejection fraction ≤ 45% with at least 3 akinetic segments in the LAD perfusion territory at echocardiogram performed 24 hours after PCI.

Exclusion Criteria

• Exclusion criteria are age ≥ 80 years, cardiogenic shock (Killip IV), multivessel coronary artery disease, serious renal or hepatic disease, blood cells disorders, documented cancer or terminal illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL