Ignite Creation Date:
2024-05-05 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00711542
Status:
TERMINATED
Last Update Posted:
2017-01-12
First Post:
2008-07-08
Brief Title:
Effects of Intracoronary Progenitor Cell Therapy on Coronary Flow Reserve After Acute MI
Sponsor:
Johann Wolfgang Goethe University Hospital
Organization:
Johann Wolfgang Goethe University Hospital
Study Overview
Official Title:
Reinfusion of Enriched Progenitor Cells And Infarct Remodeling in Acute Coronary Syndrome REPAIR - ACS
Status:
TERMINATED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPAIR-ACS
Brief Summary:
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
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
Detailed Description:
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
In order to improve neovascularization which may then be associated with improved left ventricular contractility we initiated the current trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None