Autologous Stem Cell Transplantation in Acute Myocardial Infarction

Sponsor

Oslo University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00199823

Collaborator

University of Oslo (Other), Ullevaal University Hospital (Other)

100

Enrollment

Location

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Anterior Wall Myocardial Infarction	Genetic: Intracoronary aotologous stem cell transplantation	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

Autologous Stem Cell Transplantation in Acute Myocardial Infarction

Study Start Date :

Sep 1, 2003

Study Completion Date :

May 1, 2006

Outcome Measures

Primary Outcome Measures

whether intracoronary mBMC transplantation improve LVEF after AMI assessed by ECG-gated SPECT. []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

age 40-75 years
anterior wall AMI with 120-720 minutes from onset of symptoms to PCI
ST elevation on ECG according to WHO criteria
angiographically significant stenosis on LAD proximal to the second diagonal branch
successful PCI with stenting of culprit lesion
hypokinetic, akinetic or dyskinetic segments assessed by echocardiography in a standard 16 segment model and
CK-MB above 3 times upper reference value.

Exclusion criteria:

previous MI with established significant Q-waves on ECG
cardiogenic shock
permanent pacemaker or other contraindication to MRI
stroke with significant sequela
short life expectancy due to extra cardiac reason
uncontrolled endocrinological disturbance
HIV and/or HBV/HCV positive serology
mental disorder or other condition which interferes with patient possibility to comply with the protocol.