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. 2015 Sep 30;2015(9):CD006536. doi: 10.1002/14651858.CD006536.pub4

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