NCT01394432.
Trial name or title | Endocardial mesenchymal stem cells implantation in patients after acute myocardial infarction (ESTIMATION Study) |
Methods |
Type of study: parallel RCT
Source of funding: not reported Country of origin: Russia Number of centres: not reported Intended enrolment: 50 |
Participants |
Population: AMI with successful PCI
Age, mean (SD) each arm: not reported (30 to 75 years)
Sex, % male in each arm: not reported Number of diseased vessels: 1 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: BM‐MSC
Type of stem cells: bone marrow‐derived mesenchymal stem cells
Summary of how stem cells were isolated and type and route of delivery: not reported, except for delivery using NOGA mapping
Dose of stem cells: not reported
Timing of stem cell procedure: 7 to 10 days after PCI Comparator arm: placebo |
Outcomes | Primary outcomes: reduction of LVESV by 15% Secondary outcomes: death, Thrombosis, hospitalisation for HF, 6 min‐walk, BNP levels Outcome assessment points: baseline, 12 months Method(s): MRI |
Starting date | July 2011 |
Contact information | Principal Investigator: Professor Evgeny Pokushalov, MD; State Research Institute of Circulation Pathology, Novosibirsk, Russian Federation, 630055 |
Notes | Estimated completion date: November 2012 |