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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/26337

Title: 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, Anthony
Arnold, Roman
Assmus, Birgit
Bartunek, Jozef
Belmans, Ann
Boenig, Halvard
Crea, Filippo
Dimmeler, Stefanie
Dowlut, Sheik
Fernandez-Aviles, Francisco
Galinanes, Manuel
Garcia-Dorado, David
Hartikainen, Juha
Hill, Jonathan
Hogardt-Noll, Annette
Homsy, Christian
Janssens, Stefan
Kala, Petr
Kastrup, Jens
Martin, John
Menasche, Philippe
Miklik, Roman
Mozid, Abdul
Alberto San Roman, J.
Sanz-Ruiz, Ricardo
Tendera, Michal
Wojakowski, Wojtek
Yla-Herttuala, Seppo
Zeiher, Andreas
Issue Date: 2017
Publisher: WILEY
Citation: EUROPEAN JOURNAL OF HEART FAILURE, 19(11), p. 1545-1550
Abstract: 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.
Notes: [Mathur, Anthony; Dowlut, Sheik] Queen Mary Univ London, London, England. [Arnold, Roman; Alberto San Roman, J.] Hosp Clin Univ, ICICORELAB, Valladolid, Spain. [Assmus, Birgit; Boenig, Halvard; Dimmeler, Stefanie; Zeiher, Andreas] Goethe Univ Frankfurt, Frankfurt, Germany. [Bartunek, Jozef] VZW Cardiovasc Res Ctr Aalst, Aalst, Belgium. [Belmans, Ann] Univ Leuven, KU Leuven, Leuven, Belgium. [Belmans, Ann] Univ Hasselt, I BioStat, Leuven, Belgium. [Boenig, Halvard] DRK Blutspendedienst BaWuHe, Senden, Germany. [Crea, Filippo] Univ Cattolica Sacro Cuore, Rome, Italy. [Fernandez-Aviles, Francisco; Sanz-Ruiz, Ricardo] Hosp Gen Univ Gregorio Maranon, Madrid, Spain. [Galinanes, Manuel; Garcia-Dorado, David] Vall dHebron Univ Hosp, Barcelona, Spain. [Galinanes, Manuel; Garcia-Dorado, David] Univ Autonoma Barcelona, Res Inst, Barcelona, Spain. [Hartikainen, Juha; Yla-Herttuala, Seppo] Kuopio Univ Hosp, Kuopio, Finland. [Hartikainen, Juha; Yla-Herttuala, Seppo] Univ Eastern Finland, Kuopio, Finland. [Hill, Jonathan] Kings Coll Hosp London, London, England. [Hogardt-Noll, Annette] T2cure, Frankfurt, Germany. [Homsy, Christian] Celyad SA, Mont St Guibert, Belgium. [Janssens, Stefan] Univ Hosp Leuven, Leuven, Belgium. [Kala, Petr; Miklik, Roman] Fac Hosp, Brno, Czech Republic. [Kala, Petr; Miklik, Roman] Masaryk Univ, Brno, Czech Republic. [Kastrup, Jens] Univ Copenhagen, Rigshosp, Copenhagen, Denmark. [Martin, John] UCL, London, England. [Menasche, Philippe] Univ Paris 05, AP HP, Paris, France. [Mozid, Abdul] Barts Heart Ctr, London, England. [Tendera, Michal; Wojakowski, Wojtek] Med Univ Silesia, Katowice, Poland.
URI: http://hdl.handle.net/1942/26337
DOI: 10.1002/ejhf.829
ISI #: 000418670800031
ISSN: 1388-9842
Category: A1
Type: Journal Contribution
Appears in Collections: Research publications

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