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

000232.

Trial name or title	Efficacy of stem cell in improvement of left ventricular function in patients with acute myocardial infarction
Methods	Type of study: parallel RCT  Source of funding: Department of Biotechnology, New Delhi Country of origin: India  Number of centres: 5 Intended recruitment: 250
Participants	Population: patients with AMI  Age, mean (SD) each arm: not reported (aged 30 to 65 years)  Sex, % male in each arm: not reported Number of diseased vessels: proximal and/or mid left anterior descending artery involvement by angiography  Number of stunned hyperkinetic, etc segments: not reported  Time from symptom onset to initial treatment: > 2 hours to PCI  Statistically significant baseline imbalances between the groups? not reported
Interventions	Intervention arm: BMSC  Type of stem cells: bone marrow‐derived stem cells  Summary of how stem cells were isolated and type and route of delivery: not reported  Dose of stem cells: 5 to 10 x 10⁸ stem cells  Timing of stem cell procedure: not reported Comparator arm: no additional therapy (control)
Outcomes	Primary outcomes: changes in LVEF from baseline to 6 months  Secondary outcomes: mortality, rehospitalisation for chest pain, heart failure or arrhythmias, and safety of the intervention to 6 months  Outcome assessment points: baseline and 6 months  Method (s): multi‐gated acquisition (MUGA) scan
Starting date	July 2007
Contact information	Dept of Haematology and Bone Marrow Transplantation, R & R Army Hospital, New Delhi, India, 110 010; Lead: Dr. Velu Nair
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