Autologous Stem Cell Transplantation in Acute Myocardial Infarction

Phase 2CompletedNCT00199823

Oslo University Hospital100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Acute Anterior Wall Myocardial Infarction

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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