Clinical Trial: Autologous Stem Cell Transplantation in Acute Myocardial Infarction
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Autologous Stem Cell Transplantation in Acute Myocardial Infarction
Brief Summary:
Objectives
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.
Design
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.
Detailed Summary:
Sponsor: Oslo University Hospital
Current Primary Outcome: whether intracoronary mBMC transplantation improve LVEF after AMI assessed by ECG-gated SPECT.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
Original Secondary Outcome: Same as current
Information By: Oslo University Hospital
Dates:
Date Received: September 13, 2005
Date Started: September 2003
Date Completion: May 2006
Last Updated: July 3, 2011
Last Verified: September 2010
