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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00363324
Other study ID # 82/04
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received August 10, 2006
Last updated December 27, 2007
Start date January 2005
Est. completion date November 2007

Study information

Verified date December 2007
Source University of Oulu
Contact n/a
Is FDA regulated No
Health authority Finland: University of Helsinki
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date November 2007
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Acute ST-elevation myocardial infarction treated with thrombolytic therapy

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Procedure:
intracoronary injection of bone marrow cells


Locations

Country Name City State
Finland University of Oulu Oulu

Sponsors (1)

Lead Sponsor Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Arrhythmia risk variables
Primary left ventricular function
Primary restenosis assessed by IVUS
Secondary exercise tolerance
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