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

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.

Základní údaje

Originální název

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

Autoři

MATHUR, A. (840 Spojené státy), R. ARNOLD (724 Španělsko), B. ASSMUS (276 Německo), J. BARTUNEK (56 Belgie), A. BELMANS (56 Belgie), H. BONIG (276 Německo), F. CREA (380 Itálie), S. DIMMELER (276 Německo), S. DOWLUT (826 Velká Británie a Severní Irsko), F. FERNANDEZ-AVILES (724 Španělsko), M. GALINANES (724 Španělsko), D. GARCIA-DORADO (724 Španělsko), J. HARTIKAINEN (246 Finsko), J. HILL (826 Velká Británie a Severní Irsko), A. HOGARDT-NOLL (276 Německo), C. HOMSY (56 Belgie), S. JANSSENS (56 Belgie), Petr KALA (203 Česká republika, garant, domácí), J. KASTRUP (208 Dánsko), J. MARTIN (826 Velká Británie a Severní Irsko), P. MENASCHE (250 Francie), Roman MIKLÍK (203 Česká republika, domácí), A. MOZID (826 Velká Británie a Severní Irsko), J.A. SAN ROMAN (724 Španělsko), R. SANZ-RUIZ (724 Španělsko), M. TENDERA (616 Polsko), W. WOJAKOWSKI (616 Polsko), S. YLA-HERTTUALA (246 Finsko) a A. ZEIHER (276 Německo)

Vydání

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

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30201 Cardiac and Cardiovascular systems

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 10.683

Kód RIV

RIV/00216224:14110/17:00099247

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1002/ejhf.829

UT WoS

000418670800031

Klíčová slova anglicky

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

Štítky

EL OK

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 20. 3. 2018 10:10, Soňa Böhmová

Anotace

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.

Citovat

MATHUR, A., R. ARNOLD, B. ASSMUS, J. BARTUNEK, A. BELMANS, H. BONIG, F. CREA, S. DIMMELER, S. DOWLUT, F. FERNANDEZ-AVILES, M. GALINANES, D. GARCIA-DORADO, J. HARTIKAINEN, J. HILL, A. HOGARDT-NOLL, C. HOMSY, S. JANSSENS, Petr KALA, J. KASTRUP, J. MARTIN, P. MENASCHE, Roman MIKLÍK, A. MOZID, J.A. SAN ROMAN, R. SANZ-RUIZ, M. TENDERA, W. WOJAKOWSKI, S. YLA-HERTTUALA a A. ZEIHER. 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. European Journal of heart Failure. Hoboken: Wiley, 2017, roč. 19, č. 11, s. 1545-1550. ISSN 1388-9842. Dostupné z: https://dx.doi.org/10.1002/ejhf.829.

@article{1402750,
   author = {Mathur, A. and Arnold, R. and Assmus, B. and Bartunek, J. and Belmans, A. and Bonig, H. and Crea, F. and Dimmeler, S. and Dowlut, S. and FernandezandAviles, F. and Galinanes, M. and GarciaandDorado, D. and Hartikainen, J. and Hill, J. and HogardtandNoll, A. and Homsy, C. and Janssens, S. and Kala, Petr and Kastrup, J. and Martin, J. and Menasche, P. and Miklík, Roman and Mozid, A. and San Roman, J.A. and SanzandRuiz, R. and Tendera, M. and Wojakowski, W. and YlaandHerttuala, S. and Zeiher, A.},
   article_location = {Hoboken},
   article_number = {11},
   doi = {http://dx.doi.org/10.1002/ejhf.829},
   keywords = {Cell therapy; Cardiovascular disease; Bone marrow-derived mononuclear cells; Myocardial infarction; Heart failure; Cardiac regeneration; BAMI},
   language = {eng},
   issn = {1388-9842},
   journal = {European Journal of heart Failure},
   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},
   volume = {19},
   year = {2017}
}

TY  - JOUR
ID  - 1402750
AU  - Mathur, A. - Arnold, R. - Assmus, B. - Bartunek, J. - Belmans, A. - Bonig, H. - Crea, F. - Dimmeler, S. - Dowlut, S. - Fernandez-Aviles, F. - Galinanes, M. - Garcia-Dorado, D. - Hartikainen, J. - Hill, J. - Hogardt-Noll, A. - Homsy, C. - Janssens, S. - Kala, Petr - Kastrup, J. - Martin, J. - Menasche, P. - Miklík, Roman - Mozid, A. - San Roman, J.A. - Sanz-Ruiz, R. - Tendera, M. - Wojakowski, W. - Yla-Herttuala, S. - Zeiher, A.
PY  - 2017
TI  - 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
JF  - European Journal of heart Failure
VL  - 19
IS  - 11
SP  - 1545-1550
EP  - 1545-1550
PB  - Wiley
SN  - 13889842
KW  - Cell therapy
KW  - Cardiovascular disease
KW  - Bone marrow-derived mononuclear cells
KW  - Myocardial infarction
KW  - Heart failure
KW  - Cardiac regeneration
KW  - BAMI
N2  - 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.
ER  -

MATHUR, A., R. ARNOLD, B. ASSMUS, J. BARTUNEK, A. BELMANS, H. BONIG, F. CREA, S. DIMMELER, S. DOWLUT, F. FERNANDEZ-AVILES, M. GALINANES, D. GARCIA-DORADO, J. HARTIKAINEN, J. HILL, A. HOGARDT-NOLL, C. HOMSY, S. JANSSENS, Petr KALA, J. KASTRUP, J. MARTIN, P. MENASCHE, Roman MIKLÍK, A. MOZID, J.A. SAN ROMAN, R. SANZ-RUIZ, M. TENDERA, W. WOJAKOWSKI, S. YLA-HERTTUALA a A. ZEIHER. 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. \textit{European Journal of heart Failure}. Hoboken: Wiley, 2017, roč.~19, č.~11, s.~1545-1550. ISSN~1388-9842. Dostupné z: https://dx.doi.org/10.1002/ejhf.829.

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