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Bone Marrow Cells in Myocardial Infarction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00363324
First Posted: August 15, 2006
Last Update Posted: January 9, 2008
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.
Information provided by:
University of Oulu
  Purpose
This study is aimed to assess the effect of bone marrow cells on arrhythmia risk variables in patients with a acute myocardial infarction.

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Arrhythmia risk variables
  • left ventricular function
  • restenosis assessed by IVUS

Secondary Outcome Measures:
  • exercise tolerance

Estimated Enrollment: 100
Study Start Date: January 2005
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Acute ST-elevation myocardial infarction treated with thrombolytic therapy

Exclusion Criteria:

  • Indication for rescue PCI, severe clinical heart failure, age <18 years
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00363324


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00363324     History of Changes
Other Study ID Numbers: 82/04
First Submitted: August 10, 2006
First Posted: August 15, 2006
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:
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases