TY - JOUR
T1 - 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
AU - Mathur, Anthony
AU - Arnold, Roman
AU - Assmus, Birgit
AU - Bartunek, Jozef
AU - Belmans, Ann
AU - Bönig, Halvard
AU - Crea, Filippo
AU - Dimmeler, Stefanie
AU - Dowlut, Sheik
AU - Fernández-Avilés, Francisco
AU - Galiñanes, Manuel
AU - Garcia-Dorado, David
AU - Hartikainen, Juha
AU - Hill, Jonathan
AU - Hogardt-Noll, Annette
AU - Homsy, Christian
AU - Janssens, Stefan
AU - Kala, Petr
AU - Kastrup, Jens
AU - Martin, John
AU - Menasche, Philippe
AU - Miklik, Roman
AU - Mozid, Abdul
AU - San Román, J. Alberto
AU - Sanz-Ruiz, Ricardo
AU - Tendera, Michal
AU - Wojakowski, Wojtek
AU - Ylä-Herttuala, Seppo
AU - Zeiher, Andreas
PY - 2017/11/1
Y1 - 2017/11/1
N2 - © 2017 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. 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.
AB - © 2017 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. 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.
KW - BAMI
KW - Bone marrow-derived mononuclear cells
KW - Cardiac regeneration
KW - Cardiovascular disease
KW - Cell therapy
KW - Heart failure
KW - Myocardial infarction
U2 - 10.1002/ejhf.829
DO - 10.1002/ejhf.829
M3 - Article
VL - 19
SP - 1545
EP - 1550
JO - European Journal of Heart Failure
JF - European Journal of Heart Failure
SN - 1388-9842
IS - 11
ER -