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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
  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
Intervention Model: Parallel Assignment
Masking: None (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 Anthony Mathur, Queen Mary University of London:

Primary Outcome Measures:
  • Time from randomization to all-cause death [ Time Frame: for an average of 3 years ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 350
Study Start Date: September 2013
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2019 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569178


Contacts
Contact: Anthony Mathur, MB BChir, FRCP, PhD (+44) 2037658738 a.mathur@qmul.ac.uk

  Show 43 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, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01569178     History of Changes
Other Study ID Numbers: BAMI-01
First Submitted: March 30, 2012
First Posted: April 3, 2012
Last Update Posted: June 8, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anthony Mathur, 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