BONAMI (BOne Marrow in Acute Myocardial Infarction)

This study has been completed.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00200707
First received: September 13, 2005
Last updated: June 24, 2009
Last verified: June 2009

September 13, 2005
June 24, 2009
December 2004
January 2009   (final data collection date for primary outcome measure)
Change in Myocardial viability evaluated by thallium scintigraphy (3 months and 1 year)
Same as current
Complete list of historical versions of study NCT00200707 on ClinicalTrials.gov Archive Site
  • 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)
  • Correlation with biological parameters (hematopoietic stem cell number, etc.) at the time of cell injection
Same as current
Not Provided
Not Provided
 
BONAMI (BOne Marrow in Acute Myocardial Infarction)
Intracoronary Injection of Autologous Bone Marrow Mononuclear Cells for Severe Myocardial Infarction

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute and Severe Myocardial Infarction
Procedure: Intracoronary injection of autologous bone marrow mononuclear cells
Not Provided
Roncalli J, Mouquet F, Piot C, Trochu JN, Le Corvoisier P, Neuder Y, Le Tourneau T, Agostini D, Gaxotte V, Sportouch C, Galinier M, Crochet D, Teiger E, Richard MJ, Polge AS, Beregi JP, Manrique A, Carrie D, Susen S, Klein B, Parini A, Lamirault G, Croisille P, Rouard H, Bourin P, Nguyen JM, Delasalle B, Vanzetto G, Van Belle E, Lemarchand P. Intracoronary autologous mononucleated bone marrow cell infusion for acute myocardial infarction: results of the randomized multicenter BONAMI trial. Eur Heart J. 2011 Jul;32(14):1748-57. doi: 10.1093/eurheartj/ehq455. Epub 2010 Dec 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00200707
BRD/03/2-B
Not Provided
Not Provided
Nantes University Hospital
Not Provided
Principal Investigator: Patricia LEMARCHAND, MD Nantes University Hospital
Nantes University Hospital
June 2009

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