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Effects of Intracoronary Progenitor Cell Therapy on Coronary Flow Reserve After Acute MI

NCT00711542 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2017-01-12

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

autologous bone marrow-derived progenitor cells

intracoronary infusion of autologous bone marrow-derived progenitor cells isolated from 50 ml bone marrow aspirate

BIOLOGICAL

placebo medium

intracoronary infusion of placebo medium

Sponsors & Collaborators

  • University of Leipzig

    collaborator OTHER

  • Johann Wolfgang Goethe University Hospital

    lead OTHER

Principal Investigators

  • Andreas M Zeiher, MD · Goethe University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00711542 on ClinicalTrials.gov