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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Barts & The London NHS Trust
Sponsor:
Information provided by (Responsible Party):
Anthony Mathur, Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT01569178
First received: March 30, 2012
Last updated: November 19, 2013
Last verified: November 2013

March 30, 2012
November 19, 2013
September 2013
May 2017   (final data collection date for primary outcome measure)
Time from randomization to all-cause death [ Time Frame: for an average of 3 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • time from randomization to cardiovascular rehospitalisation [ Time Frame: for an average of 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • bleeding by BARC definition [ Time Frame: for an average of 3 years ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
3000
May 2018
May 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • men and women of any ethnic origin aged≥18years
  • patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI
  • 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) 3 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
  • 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 before, e.g. at the time of acute PCI, are permitted)
  • 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 diarrhea within 4 weeks prior screening
  • History of 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
Both
18 Years and older
No
Contact: Anthony Mathur, MB BChir, FRCP, PhD (+44) 2089832448 a.mathur@qmul.ac.uk
France,   Belgium,   Czech Republic,   Spain,   Finland,   Germany,   United Kingdom,   Norway,   Denmark,   Poland,   Italy
 
NCT01569178
BAMI-01
Yes
Anthony Mathur, Barts & The London NHS Trust
Barts & The London NHS Trust
Not Provided
Principal Investigator: Anthony Mathur, MD, FRCP, PhD Queen Mary University of London
Barts & The London NHS Trust
November 2013

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