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Bone Marrow Cells in Myocardial Infarction

This study has been completed.
Information provided by:
University of Oulu Identifier:
First received: August 10, 2006
Last updated: December 27, 2007
Last verified: December 2007
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00363324

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00363324     History of Changes
Other Study ID Numbers: 82/04
Study First Received: August 10, 2006
Last Updated: December 27, 2007

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

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on August 18, 2017