BONAMI (BOne Marrow in Acute Myocardial Infarction)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00200707
First received: September 13, 2005
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

Emerging evidence suggests that stem cells and progenitor cells derived from bone marrow can be used to improve cardiac function in patients after acute myocardial infarction. In this randomised trial, we aim to assess whether intracoronary transfer of autologous bone-marrow cells could improve myocardial viability at 3 and 12 months' follow-up.


Condition Intervention Phase
Acute and Severe Myocardial Infarction
Procedure: Intracoronary injection of autologous bone marrow mononuclear cells
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intracoronary Injection of Autologous Bone Marrow Mononuclear Cells for Severe Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Change in Myocardial viability evaluated by thallium scintigraphy (3 months and 1 year) [ Time Frame: after 3 months and 1 year of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Left ventricle ejection fraction (LVEF) evaluated by radionuclide ventriculography, (3 and 12 months) and by echography (1, 3, 6, and 12 months). Segmental EF and myocardial viability evaluated by MRI (3 months) [ Time Frame: after 1,3,6 ,12 months of treatment ] [ Designated as safety issue: No ]
  • Correlation with biological parameters (hematopoietic stem cell number, etc.) at the time of cell injection

Enrollment: 101
Study Start Date: December 2004
Study Completion Date: April 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: The treatment group
Intracoronary Injection of Autologous Bone Marrow Mononuclear C
Procedure: Intracoronary injection of autologous bone marrow mononuclear cells
No Intervention: the control group

Detailed Description:

After successful percutaneous coronary intervention (PCI) for acute myocardial infarction, 100 patients are randomly assigned to either a control group (n=50) who receives an optimal medical treatment, or a bone-marrow-cell group (n=50) who receives an optimal medical treatment and intracoronary transfer of autologous bone-marrow cells 7•10 days after PCI.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women between 18-75 years.
  • Acute myocardial infarction
  • Absence of viability in the infarcted zone and LVEF <45%.

Exclusion Criteria:

  • History of prior myocardial infarction
  • Significant stenosis in another coronary territory than the acutely treated vessel
  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: NCT00200707

Locations
France
Nantes University Hospital
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Patricia LEMARCHAND, MD Nantes University Hospital
  More Information

No publications provided by Nantes University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00200707     History of Changes
Other Study ID Numbers: BRD/03/2-B
Study First Received: September 13, 2005
Last Updated: April 29, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Cell therapy
bone marrow mononuclear cells
myocardial infarction

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 23, 2014