Autologous Stem Cell Transplantation in Acute Myocardial Infarction

July 3, 2011 updated by: Oslo University Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0027
        • Rikshospitalet-Radiumhospitalet HF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University of Oslo
Ullevaal University Hospital

Investigators

  • Principal Investigator: Ketil Lunde, MD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion

May 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

July 6, 2011

Last Update Submitted That Met QC Criteria

July 3, 2011

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-03115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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