Autologous Stem Cell Transplantation in Acute Myocardial Infarction

This study has been completed.
Sponsor:
Collaborators:
University of Oslo
Ullevaal University Hospital
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00199823
First received: September 13, 2005
Last updated: July 3, 2011
Last verified: September 2010
  Purpose

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 Intervention Phase
Acute Anterior Wall Myocardial Infarction
Genetic: Intracoronary aotologous stem cell transplantation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Autologous Stem Cell Transplantation in Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

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

Estimated Enrollment: 100
Study Start Date: September 2003
Estimated Study Completion Date: May 2006
  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199823

Locations
Norway
Rikshospitalet-Radiumhospitalet HF
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Ullevaal University Hospital
Investigators
Principal Investigator: Ketil Lunde, MD Oslo University Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00199823     History of Changes
Other Study ID Numbers: S-03115
Study First Received: September 13, 2005
Last Updated: July 3, 2011
Health Authority: Norway: Norwegian Medicines Agency
Norway: The Data Inspectorate

Keywords provided by Oslo University Hospital:
Myocardial infarction
bone marrow cells
cell transplantation

Additional relevant MeSH terms:
Anterior Wall Myocardial Infarction
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014