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
  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 Barts & The London NHS Trust:

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
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
  • 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
  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

Locations
Belgium
Cardiovascular Research Centre VZW Not yet recruiting
Aalst, Belgium
Principal Investigator: Jozef Bartunek         
Katholieke Universiteit Leuven Recruiting
Leuven, Belgium
Principal Investigator: Stefan Janssens         
Czech Republic
Fakultni Nemocnice BRNO Not yet recruiting
Brno, Czech Republic
Principal Investigator: Petr Kala         
Denmark
Region Hovedstaden Not yet recruiting
Copenhagen, Denmark
Principal Investigator: Jens Kastrup         
Finland
Ita-Suomen Yliopisto Not yet recruiting
Kuopio, Finland
Principal Investigator: Seppo Yla-Herttuala         
France
Assitance Publique - Hopitaux de Paris Not yet recruiting
Paris, France
Principal Investigator: Philippe Menasche         
Germany
Johann Wolfgang Goethe Universitaet Frankfurt AM MAIN Recruiting
Frankfurt, Germany
Principal Investigator: Andreas Zeiher         
Medizinische Hochschule Hannover (MHH) Not yet recruiting
Hannover, Germany
Principal Investigator: Kai Wollert         
Universitaet Rostock Not yet recruiting
Rostock, Germany
Principal Investigator: Gustav Steinhoff         
Italy
Universita Cattolica Del Sacro Cuore Not yet recruiting
Rome, Italy
Principal Investigator: Filippo Crea         
Norway
Oslo Universitetssykehus HF Not yet recruiting
Oslo, Norway
Principal Investigator: Ketil Lunde         
Poland
Slaski Uniwersytet Medyczny w Katowicach Not yet recruiting
Katowice, Poland
Principal Investigator: Michal Tendera         
Spain
Institut Català de la Salut Not yet recruiting
Barcelona, Spain
Principal Investigator: Manuel Galinanes         
Servico Madrileno De Salud Not yet recruiting
Madrid, Spain
Principal Investigator: Francisco Fernandez-Aviles         
United Kingdom
University College London (UCL) Not yet recruiting
London, United Kingdom
Principal Investigator: John Martin         
Queen Mary, University of London (QMUL) Recruiting
London, United Kingdom
King's College London (KCL) Not yet recruiting
London, United Kingdom
Principal Investigator: Jonathan Hill         
Sponsors and Collaborators
Barts & The London NHS Trust
Investigators
Principal Investigator: Anthony Mathur, MD, FRCP, PhD Queen Mary University of London
  More Information

No publications provided

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: November 19, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Barts & The London NHS Trust:
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
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014