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Bone Marrow Cells in 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: NCT00363324
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : January 9, 2008
Information provided by:
University of Oulu

Brief Summary:
This study is aimed to assess the effect of bone marrow cells on arrhythmia risk variables in patients with a acute myocardial infarction.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Procedure: intracoronary injection of bone marrow cells Phase 2 Phase 3

Detailed Description:
This is a randomized, double-blinded study, where patients treated with thrombolytic therapy for acute myocardial infarction are randomized to receive bone-marrow derived stem cells or sham-infusion at the time percutaneous coronary intervention of the target vessel. The end-points are many arrhythmia risk variables, suchs as heart rate variability, T-wave alternans and many ECG variables as well as systolic and diastolic left ventricular function.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Autologous Bone Marrow Celss on Acute ST-Elevation Myocardial Infarction
Study Start Date : January 2005
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Primary Outcome Measures :
  1. Arrhythmia risk variables
  2. left ventricular function
  3. restenosis assessed by IVUS

Secondary Outcome Measures :
  1. exercise tolerance

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acute ST-elevation myocardial infarction treated with thrombolytic therapy

Exclusion Criteria:

  • Indication for rescue PCI, severe clinical heart failure, age <18 years

Information from the National Library of Medicine

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 identifier (NCT number): NCT00363324

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University of Oulu
Oulu, Finland, 90220
Sponsors and Collaborators
University of Oulu
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Principal Investigator: Heikki V Huikuri, Professor University of Oulu

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00363324     History of Changes
Other Study ID Numbers: 82/04
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: January 9, 2008
Last Verified: December 2007

Keywords provided by University of Oulu:
stem cell
acute myocardial infarction

Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases