EUCTR 2006‐001772‐20‐ES.

Trial name or title	Effect of intracoronary injection of autologous stem cells on left ventricular ejection fraction and volumes one year after an acute myocardial infarction
Methods	Type of study: parallel RCT Source of funding: Clinica Rotger Country of origin: Spain Number of centres: not reported Intended recruitment: 60
Participants	Population: patients with AMI Age, mean (SD) each arm: not reported (8 to 75 years) Sex, % male in each arm: not reported Number of diseased vessels: not reported Number of stunned hyperkinetic, etc segments: > 2 segments Time from symptom onset to initial treatment: not reported Statistically significant baseline imbalances between the groups? not reported
Interventions	Intervention arm: BMSC Type of stem cells: bone marrow mononuclear cells (BMMNC) Summary of how stem cells were isolated and type and route of delivery: bone marrow aspirate and gradient centrifugation. Following the method set up by Schachinger 2006. Dose of stem cells: not reported Timing of stem cell procedure: not reported Comparator arm: placebo (saline)
Outcomes	Primary outcomes: changes in LVEF, LVEDV, LVESV, perfusion, scar size Secondary outcomes: changes in LVEF at 6 months (by echocardiography and LV angiography), major adverse clinical cardiac events Outcome assessment points: baseline and 12 months Method(s): not reported
Starting date	Not reported
Contact information	Not reported
Notes	—