Autologous Stem Cell Transplantation in Acute Myocardial Infarction
Intracoronary transplantation of different cell populations have been used in acute myocardial infarction (AMI) with promising results. The primary objective of the ASTAMI study is to test whether intracoronary transplantation of autologous mononuclear bone marrow cells (mBMC) improve left ventricular ejection fraction (LVEF) after anterior wall AMI.
The ASTAMI study is a randomized, controlled, prospective study. One hundred patients with acute anterior wall ST-elevation myocardial infarction (STEMI) treated with acute PCI are randomized in a 1:1 way to either intracoronary transplantation of autologous mBMC 5-8 days after PCI or to control. Left ventricular function, exercise capacity, biochemical status, functional class, quality of life and complications are validated at baseline and during a 12-month follow up.
|Acute Anterior Wall Myocardial Infarction||Genetic: Intracoronary aotologous stem cell transplantation||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Autologous Stem Cell Transplantation in Acute Myocardial Infarction|
- whether intracoronary mBMC transplantation improve LVEF after AMI assessed by ECG-gated SPECT.
- To test whether mBMC treatment improve exercise capacity assessed by bicycle ergometry
- To test whether mBMC treatment improve quality of life assessed by the SF 36 formula
|Study Start Date:||September 2003|
|Estimated Study Completion Date:||May 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199823
|Oslo, Norway, 0027|
|Principal Investigator:||Ketil Lunde, MD||Oslo University Hospital|