BAMI. The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction

Phase 3

Completed

• Conditions: Death; Myocardial Infarction

• 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

Study Timeline

• Study First Submitted: 2012-03-30
• Study First Submitted QC: 2012-04-02
• Study First Posted: 2012-04-03
• Study Start: 2013-09
• Primary Completion: 2019-11-27
• Study Completion: 2019-11-27
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-08
• Last Update Posted: 2021-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

• 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

Exclusion Criteria

• 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

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
Time from randomization to cardiac death	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
incidence and severity of adverse events	for an average of 3 years
bleeding by BARC definition	for an average of 3 years

Trial Locations

Locations (33)

Cardiovascular Research Centre VZW; 🇧🇪 Aalst, Belgium

Katholieke Universiteit Leuven; 🇧🇪 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, Germany

UniLinikum Bonn; 🇩🇪 Bonn, Germany

Universtitatsklinikum Dusseldorf, Klinik fur Kardiologie, Pneumologie und Angiologie; 🇩🇪 Dusseldorf, Germany

HELIOS Klinikum Erfurt GmbH; 🇩🇪 Erfurt, Germany

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