BONAMI (BOne Marrow in Acute 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.
Acute and Severe Myocardial Infarction
Procedure: Intracoronary injection of autologous bone marrow mononuclear cells
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intracoronary Injection of Autologous Bone Marrow Mononuclear Cells for Severe Myocardial Infarction|
- Change in Myocardial viability evaluated by thallium scintigraphy (3 months and 1 year)
- 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
|Study Start Date:||December 2004|
|Study Completion Date:||April 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
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.