J 2017

The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: rationale and design of the BAMI trial

MATHUR, A., R. ARNOLD, B. ASSMUS, J. BARTUNEK, A. BELMANS et. al.

Basic information

Original name

The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: rationale and design of the BAMI trial

Authors

MATHUR, A. (840 United States of America), R. ARNOLD (724 Spain), B. ASSMUS (276 Germany), J. BARTUNEK (56 Belgium), A. BELMANS (56 Belgium), H. BONIG (276 Germany), F. CREA (380 Italy), S. DIMMELER (276 Germany), S. DOWLUT (826 United Kingdom of Great Britain and Northern Ireland), F. FERNANDEZ-AVILES (724 Spain), M. GALINANES (724 Spain), D. GARCIA-DORADO (724 Spain), J. HARTIKAINEN (246 Finland), J. HILL (826 United Kingdom of Great Britain and Northern Ireland), A. HOGARDT-NOLL (276 Germany), C. HOMSY (56 Belgium), S. JANSSENS (56 Belgium), Petr KALA (203 Czech Republic, guarantor, belonging to the institution), J. KASTRUP (208 Denmark), J. MARTIN (826 United Kingdom of Great Britain and Northern Ireland), P. MENASCHE (250 France), Roman MIKLÍK (203 Czech Republic, belonging to the institution), A. MOZID (826 United Kingdom of Great Britain and Northern Ireland), J.A. SAN ROMAN (724 Spain), R. SANZ-RUIZ (724 Spain), M. TENDERA (616 Poland), W. WOJAKOWSKI (616 Poland), S. YLA-HERTTUALA (246 Finland) and A. ZEIHER (276 Germany)

Edition

European Journal of heart Failure, Hoboken, Wiley, 2017, 1388-9842

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30201 Cardiac and Cardiovascular systems

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

Impact factor

Impact factor: 10.683

RIV identification code

RIV/00216224:14110/17:00099247

Organization unit

Faculty of Medicine

DOI

UT WoS

000418670800031

Keywords in English

Cell therapy; Cardiovascular disease; Bone marrow-derived mononuclear cells; Myocardial infarction; Heart failure; Cardiac regeneration; BAMI

Tags

Tags

International impact, Reviewed
Změněno: 20/3/2018 10:10, Soňa Böhmová

Abstract

V originále

Over the past 13 years bone marrow-derived mononuclear cells (BM-MNCs) have been widely investigated for clinical efficacy in patients following acute myocardial infarction (AMI). These early phase II trials have used various surrogate markers to judge efficacy and, although promising, the results have been inconsistent. The phase III BAMI trial has therefore been designed to demonstrate that intracoronary infusion of BM-MNCs is safe and will significantly reduce the time to first occurrence of all-cause death in patients with reduced left ventricular ejection fraction after successful reperfusion for ST-elevation AMI (powered with the aim of detecting a 25% reduction in all-cause mortality). This is a multinational, multicentre, randomized, open-label, controlled, parallel-group phase III study aiming to enrol approximately 3000 patients in 11 European countries with at least 17 sites. Eligible patients who have impaired left ventricular ejection (<= 45%) following successful reperfusion for AMI will be randomized to treatment or control group in a 1: 1 ratio. The treatment group will receive intracoronary infusion of BM-MNCs 2-8 days after successful reperfusion for AMI added on top of optimal standard of care. The control group will receive optimal standard of care. The primary endpoint is time from randomization to all-cause death. The BAMI trial is pivotal and the largest trial to date of BM-MNCs in patients with impaired left ventricular function following AMI. The aim of the trial is to provide a definitive answer as to whether BM-MNCs reduce all-cause mortality in this group of patients.