Bone Marrow Cells in Myocardial Infarction - Full Text View

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 II Phase III

MedlinePlus related topics:

Heart Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Effects of Autologous Bone Marrow Celss on Acute ST-Elevation Myocardial Infarction

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363324

Locations


Finland
	University of Oulu
	Oulu, Finland, 90220
	University of Oulu
	Oulu, Finland, 90220

Sponsors and Collaborators

University of Oulu

Investigators


Principal Investigator:	Heikki V Huikuri, Professor	University of Oulu

More Information

Study ID Numbers:	82/04
First Received:	August 10, 2006
Last Updated:	December 27, 2007
ClinicalTrials.gov Identifier:	NCT00363324
Health Authority:	Finland: University of Helsinki

Keywords provided by University of Oulu:

stem cell

acute myocardial infarction

Study placed in the following topic categories:

Necrosis

Heart Diseases

Myocardial Ischemia

Vascular Diseases

Ischemia

Infarction

Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	University of Oulu
Information provided by:	University of Oulu
ClinicalTrials.gov Identifier:	NCT00363324