Evidence map›Paper›PMID 28948706›Full record

Trial reportEuropean journal of heart failure2017

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.

Anthony Mathur, Roman Arnold, Birgit Assmus, Jozef Bartunek, Ann Belmans, Halvard Bönig, Filippo Crea, Stefanie Dimmeler, Sheik Dowlut, Francisco Fernández-Avilés and 19 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in European journal of heart failure, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed.

  1. Review
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  11. Highlights from the European society of cardiology congress 2020.Journal of thrombosis and thrombolysis · 2021
    Article
  12. Review
  13. Article
  14. Observational
  15. Article
  16. Function Follows Form - A Review of Cardiac Cell Therapy.Circulation journal : official journal of the Japanese Circulation Society · 2019
    Review
  17. Review
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors.

Anthony MathurQueen Mary University of London, London, UK.
Roman ArnoldICICORELAB, Hospital Clínico Universitario, Valladolid, Spain.
Birgit AssmusJohann-Wolfgang-Goethe University, Frankfurt, Germany.
Jozef BartunekVZW Cardiovascular Research Center Aalst, Aalst, Belgium.
Ann BelmansKU Leuven-University of Leuven & Universiteit Hasselt, I-BioStat, Leuven, Belgium.
Halvard BönigJohann-Wolfgang-Goethe University, Frankfurt and DRK-Blutspendedienst BaWüHe, Germany.
Filippo CreaCatholic University of the Sacred Heart, Rome, Italy.
Stefanie DimmelerJohann-Wolfgang-Goethe University, Frankfurt, Germany.
Sheik DowlutQueen Mary University of London, London, UK.
Francisco Fernández-AvilésHospital General Universitario Gregorio Marañón, Madrid, Spain.
Manuel GaliñanesVall d'Hebron University Hospital and Research Institute, Universitat Autònoma de Barcelona, Spain.
David Garcia-DoradoVall d'Hebron University Hospital and Research Institute, Universitat Autònoma de Barcelona, Spain.
Juha HartikainenKuopio University Hospital and University of Eastern Finland, Kuopio, Finland.
Jonathan HillKing's College Hospital, London, UK.
Annette Hogardt-Nollt2cure, Frankfurt, Germany.
Christian HomsyCelyad SA, Mont-Saint-Guibert, Belgium.
Stefan JanssensUniversity Hospitals Leuven, Leuven, Belgium.
Petr KalaFaculty Hospital and Masaryk University, Brno, Czech Republic.
Jens KastrupRigshospitalet University of Copenhagen, Copenhagen, Denmark.
John MartinUniversity College London, London, UK.
Philippe MenascheAssistance Publique Hopitaux de Paris, University Paris Descartes, Paris, France.
Roman MiklikFaculty Hospital and Masaryk University, Brno, Czech Republic.
Abdul MozidBarts Heart Centre, London, UK.
J Alberto San RománICICORELAB, Hospital Clínico Universitario, Valladolid, Spain.
Ricardo Sanz-RuizHospital General Universitario Gregorio Marañón, Madrid, Spain.
Michal TenderaMedical University of Silesia, Katowice, Poland.
Wojtek WojakowskiMedical University of Silesia, Katowice, Poland.
Seppo Ylä-HerttualaKuopio University Hospital and University of Eastern Finland, Kuopio, Finland.
Andreas ZeiherJohann-Wolfgang-Goethe University, Frankfurt, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Bone Marrow TransplantationCause of DeathEchocardiographyEuropeFemaleHumansMaleST Elevation Myocardial InfarctionSurvival RateTreatment OutcomeVentricular Function, LeftBAMIBone marrow-derived mononuclear cellsCardiac regenerationCardiovascular diseaseCell therapyHeart failureMyocardial infarction

Identifiers

PMID28948706
PMCPMC6607485

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.