NCT00669227

Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction (SCAMI)

Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction - A Randomized, Double-blind, Placebo Controlled Trial (SCAMI)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: University of Ulm · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Autologous stem cells may improve myocardial regeneration after intracoronary administration in patients with acute myocardial infarction. The primary hypothesis of this prospective, placebo-controlled, double-blind trial is that the increase of ejection fraction determined by magnetic resonance imaging between baseline and 6 months follow-up is superior in active treated patients compared to patients receiving placebo. The study includes an integrated pilot phase of 40 patients for evaluation of left ventricular ejection fraction determined by cardiac magnetic resonance imaging. Based on the data of this analysis the final sample size will be calculated. The primary endpoint is the improvement in left ventricular ejection fraction with an assumed 2.5% higher improvement in the cell treated population compared to the placebo treated group.

Detailed description

There is a 2:1 randomization for bone marrow cell therapy versus placebo therapy. Patients will be stratified according to age, localization of myocardial infarction and left ventricular function.

Conditions

• Acute Myocardial Infarction
• Coronary Artery Disease

Interventions

Type	Name	Description
OTHER	autologous stem cells	intracoronary administration at the same day of cell aspiration using the stop flow technique
OTHER	placebo suspension	intracoronary administration at the same day as cell aspiration

Timeline

• Start date: 2005-10-01
• Primary completion: 2009-01-01
• First posted: 2008-04-30
• Last updated: 2014-06-10

Locations

1 site across 1 country: Germany