Autologous Stem Cell Transplantation in Acute Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00199823
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 6, 2011
University of Oslo
Ullevaal University Hospital
Information provided by:
Oslo University Hospital

September 13, 2005
September 20, 2005
July 6, 2011
September 2003
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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 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
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Autologous Stem Cell Transplantation in Acute Myocardial Infarction
Autologous Stem Cell Transplantation in Acute Myocardial Infarction


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.


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.

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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Acute Anterior Wall Myocardial Infarction
Genetic: Intracoronary aotologous stem cell transplantation
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2006
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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.
Sexes Eligible for Study: All
40 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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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