BAMI. The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction
- Conditions
- DeathMyocardial Infarction
- Interventions
- Procedure: Bone Marrow aspiration and intracoronary reinfusion
- Registration Number
- NCT01569178
- Lead Sponsor
- Queen Mary University of London
- Brief Summary
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(\</=45%) after successful reperfusion for acute myocardial infarction when compared to a control group of patients undergoing best medical care.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 375
- signed and dated informed consent form
- men and women of any ethnic origin aged≥18years
- patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI (including new LBBB)
- Patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI.
- Successful acute reperfusion therapy (residual stenosis visually <50% and TIMI flow ≥2) within 24 hours of symptom onset or thrombolysis within 12 hours of symptom onset followed by successful percutaneous coronary intervention (PCI) within 24 hours after thrombolysis
- Left ventricular ejection fraction ≤ 45% with significant regional wall motion abnormality assessed by quantitative echocardiography (central, independent core lab analysis) 2 to 6 days after reperfusion therapy
- Open coronary artery suitable for cell infusion supplying the target area of abnormal wall motion
- Participation in another clinical trial within 30 days prior randomisation unless non interventional trials or trials where patients are randomised to only standard care and this has been discussed and agreed with the CI/sponsor prior to consenting
- Previously received stem/progenitor cell therapy
- Pregnant or nursing women
- Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
- Necessity to revascularise additional vessels, outside the target coronary artery at the time of progenitor cell infusion (additional revascularisations after primary PCI and before BM-MNC cell infusion are allowed), unless clinically indicated and according to latest guidelines. This decision should be made at the time of the index procedure and explicitly stated at that time.
- Cardiogenic shock requiring mechanical support
- Platelet count <100.000/µl, or hemoglobin <8.5 g/dl
- Impaired renal function, i.e. creatinine >2.5 mg/dl
- Fever or diarrhoea not responsive to treatment within 4 weeks prior screening
- Cliinically significant bleeding disorder within 3 months prior screening
- Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg)
- Life expectancy of less than two years from any non-cardiac cause or uncontrolled neoplastic disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intracoronary Reinfusion of Cells Bone Marrow aspiration and intracoronary reinfusion Bone marrow-derived progenitor cells aspiration and Intracoronary reinfusion of the cells
- Primary Outcome Measures
Name Time Method Time from randomization to all-cause death for an average of 3 years
- Secondary Outcome Measures
Name Time Method bleeding by BARC definition for an average of 3 years Time from randomization to cardiac death for an average of 3 years incidence and severity of adverse events for an average of 3 years time from randomization to cardiovascular rehospitalisation for an average of 3 years time from randomization to cardiovascular rehospitalisation for recurrent MI, coronary revascularisation procedures, heart failure, Implantation of ICD.CRT device, stroke, syncope or Arrhythmias
Trial Locations
- Locations (33)
Johann Wolfgang Goethe Universitaet Frankfurt AM MAIN
🇩🇪Frankfurt, Germany
Klinikum Fulda gAG
🇩🇪Fulda, Germany
Krankenhaus Hetzelstift Neustadt
🇩🇪Neustadt, Germany
UMC Utrecht
🇳🇱Utrecht, Netherlands
Cardiocentro Ticino
🇨🇭Lugano, Switzerland
Region Hovedstaden
🇩🇰Copenhagen, Denmark
Cardiovascular Research Centre VZW
🇧🇪Aalst, Belgium
Katholieke Universiteit Leuven
🇧🇪Leuven, Belgium
Kuopio University Hospital
🇫🇮Kuopio, Finland
Zentralklinik Bad Berka
🇩🇪Bad Berka, Germany
Fakultni Nemocnice BRNO
🇨🇿Brno, Czechia
Universitatsmedizin Greifswald Klinik Und Poliklinik Innere Med
🇩🇪Greifswald, Germany
Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Universitätsmedizin Charité Berlin
🇩🇪Berlin, Germany
HELIOS Klinikum Erfurt GmbH
🇩🇪Erfurt, Germany
UniLinikum Bonn
🇩🇪Bonn, Germany
Universtitatsklinikum Dusseldorf, Klinik fur Kardiologie, Pneumologie und Angiologie
🇩🇪Dusseldorf, Germany
University Hospital Essen
🇩🇪Essen, Germany
UKSh Campus Lubeck, Med. Klinik II
🇩🇪Lubeck, Germany
University Hospital Ulm, Clinic of Internal Medicine II
🇩🇪Ulm, Germany
SRH Zentralklinikum Suhl GmbH
🇩🇪Suhl, Germany
Universita Cattolica Del Sacro Cuore
🇮🇹Rome, Italy
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Hospital Universitario Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Clinico Salamanca
🇪🇸Salamanca, Spain
Hospital Universitario Fundacion Alcorcon
🇪🇸Madrid, Spain
Servico Madrileno De Salud
🇪🇸Madrid, Spain
H.U. Marques de Valdecilla
🇪🇸Santander, Spain
Hospital Clinico Universitario De Valladolid
🇪🇸Valladolid, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Hospiatl Universitatio Miguel Servet
🇪🇸Zaragoza, Spain
Queen Mary, University of London (QMUL)
🇬🇧London, United Kingdom
New Cross Hospital, Royal Wolverhampton NHS Trust
🇬🇧Wolverhampton, United Kingdom