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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
42
intracoronary administration at the same day of cell aspiration using the stop flow technique
intracoronary administration at the same day as cell aspiration
University of Ulm
Ulm, Germany
difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 6 months follow-up
Time frame: 6 months
left ventricular ejection fraction measured by magnetic resonance imaging
Time frame: 1, 3, 12 months
left ventricular enddiastolic volume measured by magnetic resonance imaging
Time frame: 1, 3, 6, 12 months
left ventricular endsystolic volume measured by magnetic resonance imaging
Time frame: 1, 3, 6, 12 months
major adverse cardiac events
Time frame: 1, 3, 6, 12 months
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