Coronary Artery Disease Clinical Trial
Official title:
Reinfusion of Enriched Progenitor Cells And Infarct Remodeling in Acute Coronary Syndrome: 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.
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.
;
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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