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The Impact of Repeated Intracoronary Injection of Autologous Bone-marrow Derived Mononuclear Cells for Left Ventricle Contractility and Remodeling in Patients With STEMI.Prospective Randomized Study. (RACE-STEMI)
This is multicentre, randomised open-label, controlled, parallel-group phase III study. Its aim is to demonstrate that a triple intracoronary infusion of autologous bone marrow-derived mononuclear cells in addition to state of the art treatment is safe and reduces all-cause mortality in patients with reduced left ventricular ejection fraction (≤45%) after successful reperfusion for acute myocardial infarction when compared to a control group of patients undergoing best medical care.
Details
| Lead sponsor | American Heart of Poland |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 200 |
| Start date | 2019-03 |
| Completion | 2022-12 |
Conditions
- Heart Failure
- Myocardial Infarction
Interventions
- Intracoronary infusion of BM-MC
Primary outcomes
- Left ventricle ejection fraction change evaluated by CT — 12 months
Countries
Poland