Bone Marrow Cells in Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by:
University of Oulu
ClinicalTrials.gov Identifier:
NCT00363324
First received: August 10, 2006
Last updated: December 27, 2007
Last verified: December 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Oulu

Additional 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
Study First Received: August 10, 2006
Last Updated: December 27, 2007
Health Authority: Finland: University of Helsinki

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

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

ClinicalTrials.gov processed this record on July 24, 2014