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

This study is currently recruiting participants.
Verified June 2017 by Anthony Mathur, Queen Mary University of London
Sponsor:
ClinicalTrials.gov Identifier:
NCT01569178
First Posted: April 3, 2012
Last Update Posted: June 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Anthony Mathur, Queen Mary University of London
March 30, 2012
April 3, 2012
June 8, 2017
September 2013
October 2019   (Final data collection date for primary outcome measure)
Time from randomization to all-cause death [ Time Frame: for an average of 3 years ]
Same as current
Complete list of historical versions of study NCT01569178 on ClinicalTrials.gov Archive Site
  • Time from randomization to cardiac death [ Time Frame: for an average of 3 years ]
  • time from randomization to cardiovascular rehospitalisation [ Time Frame: 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 [ Time Frame: for an average of 3 years ]
  • bleeding by BARC definition [ Time Frame: for an average of 3 years ]
Same as current
Not Provided
Not Provided
 
BAMI. The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction
The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction.
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Myocardial Infarction
  • Death
Procedure: Bone Marrow aspiration and intracoronary reinfusion
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
  • No Intervention: standard care
    optimal standard care post myocardial infarction
  • Experimental: Intracoronary Reinfusion of Cells
    Bone marrow-derived progenitor cells aspiration and Intracoronary reinfusion of the cells
    Intervention: Procedure: Bone Marrow aspiration and intracoronary reinfusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
October 2019
October 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Anthony Mathur, MB BChir, FRCP, PhD (+44) 2037658738 a.mathur@qmul.ac.uk
Belgium,   Czechia,   Denmark,   Finland,   France,   Germany,   Italy,   Netherlands,   Poland,   Spain,   Switzerland,   United Kingdom
Czech Republic,   Norway
 
NCT01569178
BAMI-01
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Anthony Mathur, Queen Mary University of London
Queen Mary University of London
Not Provided
Principal Investigator: Anthony Mathur, MD, FRCP, PhD Queen Mary University of London
Queen Mary University of London
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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