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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

September 13, 2005
July 3, 2011
September 2003
Not Provided
whether intracoronary mBMC transplantation improve LVEF after AMI assessed by ECG-gated SPECT.
Same as current
Complete list of historical versions of study NCT00199823 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Autologous Stem Cell Transplantation in Acute Myocardial Infarction
Autologous Stem Cell Transplantation in Acute Myocardial Infarction

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Acute Anterior Wall Myocardial Infarction
Genetic: Intracoronary aotologous stem cell transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2006
Not Provided

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.
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00199823
S-03115
Not Provided
Not Provided
Oslo University Hospital
  • University of Oslo
  • Ullevaal University Hospital
Principal Investigator: Ketil Lunde, MD Oslo University Hospital
Oslo University Hospital
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP