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Autologous Stem Cell Transplantation in Acute Myocardial Infarction

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ClinicalTrials.gov Identifier: NCT00199823
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 6, 2011
Sponsor:
Collaborators:
University of Oslo
Ullevaal University Hospital
Information provided by:
Oslo University Hospital

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Acute Anterior Wall Myocardial Infarction Genetic: Intracoronary aotologous stem cell transplantation Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Autologous Stem Cell Transplantation in Acute Myocardial Infarction
Study Start Date : September 2003
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. whether intracoronary mBMC transplantation improve LVEF after AMI assessed by ECG-gated SPECT.

Secondary Outcome Measures :
  1. To test whether mBMC treatment improve exercise capacity assessed by bicycle ergometry
  2. To test whether mBMC treatment improve quality of life assessed by the SF 36 formula

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199823


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00199823    
Other Study ID Numbers: S-03115
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: September 2010
Keywords provided by Oslo University Hospital:
Myocardial infarction
bone marrow cells
cell transplantation
Additional relevant MeSH terms:
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Myocardial Infarction
Anterior Wall Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases