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. (see Contacts and Locations)
Verified June 2016 by Queen Mary University of London
Sponsor:
Information provided by (Responsible Party):
Anthony Mathur, Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT01569178
First received: March 30, 2012
Last updated: June 10, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention Phase
Myocardial Infarction
Death
Procedure: Bone Marrow aspiration and intracoronary reinfusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction.

Resource links provided by NLM:


Further study details as provided by Queen Mary University of London:

Primary Outcome Measures:
  • Time from randomization to all-cause death [ Time Frame: for an average of 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 3000
Study Start Date: September 2013
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 (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
  • 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)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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01569178

Contacts
Contact: Anthony Mathur, MB BChir, FRCP, PhD (+44) 2089832448 a.mathur@qmul.ac.uk

  Show 38 Study Locations
Sponsors and Collaborators
Queen Mary University of London
Investigators
Principal Investigator: Anthony Mathur, MD, FRCP, PhD Queen Mary University of London
  More Information

Responsible Party: Anthony Mathur, Clinical Director, Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT01569178     History of Changes
Other Study ID Numbers: BAMI-01 
Study First Received: March 30, 2012
Last Updated: June 10, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Queen Mary University of London:
stem cells
acute myocardial infarction
heart failure
heart attack
bone marrow
intracoronary reinfusion
bone marrow derived mononuclear cells
Left ventricular function improvement
mortality

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 21, 2016