Effects of Intracoronary Progenitor Cell Therapy on Coronary Flow Reserve After Acute MI (REPAIR-ACS)
Coronary flow reserve is an important measure of the integrity of the coronary microcirculation. Moreover, impaired coronary flow reserve is a predictor of future cardiovascular events and poor prognosis in patients after acute myocardial infarction.
After acute myocardial infarction, coronary flow reserve remains significantly reduced. A previous randomized, double-blind Placebo-controlled trial (REPAIR-AMI) demonstrated complete normalization of coronary flow reserve after intracoronary application of autologous bone marrow-derived progenitor cells (but no effect in the placebo group) in patients with ST segment elevation myocardial infarction. The current study is planned to extend these findings to patients with Non-ST segment elevation myocardial infarction, since these patients have an equally reduced outcome.
|Coronary Artery Disease Acute Myocardial Infarction||Biological: autologous bone marrow-derived progenitor cells Biological: placebo medium||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Reinfusion of Enriched Progenitor Cells And Infarct Remodeling in Acute Coronary Syndrome: REPAIR - ACS|
- Improvement of coronary flow reserve in the infarct vessel [ Time Frame: 4 months ]
- Improvement of relative coronary flow reserve [ Time Frame: 4 months ]
- Improvement of global and regional left ventricular ejection fraction [ Time Frame: 4 months ]
- Major adverse cardiac events (death, MI, rehospitalization for heart failure, revascularization) [ Time Frame: 4 months ]
- Major adverse cardiac events (death, MI, rehospitalization for heart failure, revascularization) [ Time Frame: 12 months ]
|Study Start Date:||September 2008|
|Study Completion Date:||December 2015|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Intracoronary infusion of autologous bone marrow-derived progenitor cells after NSTEMI
Biological: autologous bone marrow-derived progenitor cells
intracoronary infusion of autologous bone marrow-derived progenitor cells isolated from 50 ml bone marrow aspirate
Placebo Comparator: 2
Intracoronary infusion of Placebo after NSTEMI
Biological: placebo medium
intracoronary infusion of placebo medium
Improvement of neovascularization is a key mechanism of functional improvement of intracoronary application of progenitor cells after acute myocardial infarction. Since capillary density cannot be assessed histological in patients, measurement of coronary flow reserve is an exact means for estimating capillary density and assessing coronary microvascular function. With the help of an intracoronary Doppler Wire, coronary hemodynamics can be assessed at baseline and, for example, adenosin-induced maximal vasodilation. Calculation of the minimal vascular resistance indices allows to estimate the cross-sectional area, reflecting capillary density, and, in comparison with the time of the acute myocardial infarction, estimation of improved neovascularization at a later timepoint.
In order to improve neovascularization, which may then be associated with improved left ventricular contractility, we initiated the current trial.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711542
|Med. Klinik III; Kardiologie|
|Frankfurt, Germany, 60590|
|Universität Leipzig / Herzzentrum|
|Leipzig, Germany, 04289|
|Principal Investigator:||Andreas M Zeiher, MD||Goethe University|