NCT00936819.
Trial name or title | The enhanced angiogenic cell therapy ‐ acute myocardial infarction trial (ENACT‐AMI) |
Methods |
Type of study: parallel RCT
Source of funding: not reported Country of origin: Canada Number of centres: 5 Intended enrolment: 100 |
Participants |
Population: AMI
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: not reported Statistically significant baseline imbalances between the groups?: not reported |
Interventions |
Intervention arm: endothelial progenitor cells (EPC) or eNOS transfected EPC
Type of stem cells: endothelial progenitor cells (EPC)
Summary of how stem cells were isolated and type and route of delivery: not reported
Dose of stem cells: 20 x 106 cells in each treatment arm
Timing of stem cell procedure: after 5 to 7 days Comparator arm: plasmalyte and 25% autologous plasma |
Outcomes |
Primary outcome: change in LVEF Secondary outcomes: changes in wall motion, clinical worsening, QoL and safety Outcome assessment points: baseline and 6 months Method(s): MRI |
Starting date | July 2013 |
Contact information | Contact: Dr. Duncan J. Stewart, MD FRCP C, Ottawa Hospital Research Institute |
Notes | — |