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This is a multinational, multicentre, randomised open-label, controlled, parallel-group phase III study. Its aim is to demonstrate that a single intracoronary infusion of autologous bone marrow-derived mononuclear cells is safe and reduces all-cause mortality in patients with reduced left ventricular ejection fraction(\
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard care | No Intervention | optimal standard care post myocardial infarction | |
| Intracoronary Reinfusion of Cells | Experimental | Bone marrow-derived progenitor cells aspiration and Intracoronary reinfusion of the cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Marrow aspiration and intracoronary reinfusion | Procedure | Bone marrow-derived progenitor cells are obtained from 50ml bone marrow aspirated under local anaesthesia from the iliac crest. Intracoronary infusion of the cells is performed via conventional percutaneous intracoronary intervention techniques using an over-the-wire balloon technique |
| Measure | Description | Time Frame |
|---|---|---|
| Time from randomization to all-cause death | for an average of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time from randomization to cardiac death | for an average of 3 years | |
| time from randomization to cardiovascular rehospitalisation | time from randomization to cardiovascular rehospitalisation for recurrent MI, coronary revascularisation procedures, heart failure, Implantation of ICD.CRT device, stroke, syncope or Arrhythmias |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Mathur, MD, FRCP, PhD | Queen Mary University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Research Centre VZW | Aalst | Belgium | ||||
| Katholieke Universiteit Leuven |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28948706 | Derived | 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 P, Kastrup J, Martin J, Menasche P, Miklik R, Mozid A, San Roman JA, Sanz-Ruiz R, Tendera M, Wojakowski W, Yla-Herttuala S, Zeiher A. 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. Eur J Heart Fail. 2017 Nov;19(11):1545-1550. doi: 10.1002/ejhf.829. Epub 2017 Sep 25. |
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The advanced therapy treatment product used in this trial is open label, hence no masking
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|
| for an average of 3 years |
| incidence and severity of adverse events | for an average of 3 years |
| bleeding by BARC definition | for an average of 3 years |
| Leuven |
| Belgium |
| Fakultni Nemocnice BRNO | Brno | Czechia |
| Region Hovedstaden | Copenhagen | Denmark |
| Kuopio University Hospital | Kuopio | Finland |
| Zentralklinik Bad Berka | Bad Berka | Germany |
| Universitätsmedizin Charité Berlin | Berlin | 12203 | Germany |
| UniLinikum Bonn | Bonn | Germany |
| Universtitatsklinikum Dusseldorf, Klinik fur Kardiologie, Pneumologie und Angiologie | Düsseldorf | 40225 | Germany |
| HELIOS Klinikum Erfurt GmbH | Erfurt | 99089 | Germany |
| University Hospital Essen | Essen | 45147 | Germany |
| Johann Wolfgang Goethe Universitaet Frankfurt AM MAIN | Frankfurt | Germany |
| Klinikum Fulda gAG | Fulda | Germany |
| Universitatsmedizin Greifswald Klinik Und Poliklinik Innere Med | Greifswald | 17475 | Germany |
| UKSh Campus Lubeck, Med. Klinik II | Lübeck | 23538 | Germany |
| Krankenhaus Hetzelstift Neustadt | Neustadt | 67434 | Germany |
| SRH Zentralklinikum Suhl GmbH | Suhl | Germany |
| University Hospital Ulm, Clinic of Internal Medicine II | Ulm | 89081 | Germany |
| Universita Cattolica Del Sacro Cuore | Rome | Italy |
| UMC Utrecht | Utrecht | E03-511 | Netherlands |
| Hospital Universitario La Princesa | Madrid | 28006 | Spain |
| Hospital Universitario Clinico San Carlos | Madrid | 28040 | Spain |
| Fundacion Jimenez Diaz | Madrid | Spain |
| Hospital Universitario Fundacion Alcorcon | Madrid | Spain |
| Servico Madrileno De Salud | Madrid | Spain |
| Hospital Clinico Salamanca | Salamanca | Spain |
| H.U. Marques de Valdecilla | Santander | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Clinico Universitario De Valladolid | Valladolid | Spain |
| Hospiatl Universitatio Miguel Servet | Zaragoza | 50009 | Spain |
| Cardiocentro Ticino | Lugano | 6900 | Switzerland |
| Queen Mary, University of London (QMUL) | London | United Kingdom |
| New Cross Hospital, Royal Wolverhampton NHS Trust | Wolverhampton | United Kingdom |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D003643 | Death |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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