Myocardial Infarction Clinical Trial
Official title:
Reinfusion of Enriched Progenitor Cells And Infarct Remodeling in Acute Myocardial Infarction (REPAIR - AMI)
Impaired contractile function after a heart attack of the heart is a major cause of "heart
failure" limiting quality of life and prognosis, which cannot be prevented even with optimal
standard therapy, including immediate balloon/stent dilation of the infarct vessel.
The aim of the REPAIR-AMI trial is to investigate whether infusion of progenitor cells into
the infarct vessel (after successful reperfusion therapy) may improve left ventricular
contractile function compared to placebo therapy. After bone marrow aspiration progenitor
cells are enriched via a centrifugation method.
- The study is a double-blind, placebo-controlled, randomized, multicenter trial.
- Patients after an acute myocardial infarction, undergoing successful reperfusion
therapy are included.
- All patients undergo bone marrow aspiration 3 to 6 days after the infarction.
- After cell processing, enriched bone marrow-derived progenitor cells or placebo medium
is infused direct into the infarct related artery during stop-flow. In addition, a left
ventricular angiography is performed.
- After 4 months left ventricular angiography is repeated. The primary endpoint is the
difference in change of left ventricular ejection fraction between the two groups.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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