NCT00711542.
Trial name or title | Reinfusion of enriched progenitor cells and infarct remodeling in acute coronary syndrome (REPAIR‐ACS) |
Methods |
Type of study: parallel RCT
Source of funding: not reported Country of origin: Germany Number of centres: 1 Intended enrolment: 31 |
Participants |
Population: acute non‐ST segment elevation myocardial infarction, successful PCI with stent
Age, mean (SD) each arm: not reported (18‐ to 80 years)
Sex, % male in each arm: not reported Number of diseased vessels: not reported Number of stunned hyperkinetic, etc segments: not reported Time from symptom onset to initial treatment: < 48 hours Statistically significant baseline imbalances between the groups?: not reported |
Interventions |
Intervention arm: BMSC
Type of stem cells: bone marrow stem cells
Summary of how stem cells were isolated and type and route of delivery: bone marrow aspirated, preparation of media, delivery via intracoronary injection
Dose of stem cells: not reported
Timing of stem cell procedure: not reported Comparator arm: placebo medium |
Outcomes | Primary outcomes: improvement of coronary flow reserve in the infarct vessel Secondary outcomes: improvement of relative coronary flow reserve, regional and global LVEF, MACE (death, MI, rehospitalisation for heart failure, revascularisation) Outcome assessment points: baseline, 4 months and 1 year Method(s): intracoronary doppler wire |
Starting date | September 2008 |
Contact information | Andreas M Zeiher, MD (zeiher@em.uni‐frankfurt.de); Birgit Assmus, MD (b.assmus@em.uni‐frankfurt.de) |
Notes | This study has been terminated due to slow recruitment |