Status:
UNKNOWN
Stem Cell Mobilization by G-CSF Post Myocardial Infarction to Promote Myocyte Repair
Lead Sponsor:
University of Ottawa
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Myocardial Infarction
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
PHASE3
Brief Summary
Eighty-six patients with heart attacks will be identified at our hospital. Post heart attack we will assess heart function, blood flow to the heart, and heart cell function. We will assess these param...
Eligibility Criteria
Inclusion
- Large anterior wall ST elevation AMI defined by: Post AMI LVEF less than 45% as assessed by echocardiography. It is standard practice at our institution to obtain echocardiograms on such patients before day 4 post AMI.
- Age between 40 -75 years
- Angiographically patent infarct related artery (IRA) with TIMI 3 flow with no significant stenosis (\>70% diameter stenosis in non-intervened upon arteries or \>30% in arteries that had PTCA), no dissection or visible thrombus, and considered at low risk for re-occlusion by the Cardiologist performing the coronary angiography. In patients who have undergone PTCA, this assessment will be none on a post PTCA angiogram. This will be the majority of patients.
- Eligible for treatment with G-CSF within the 5 days Post AMI.
Exclusion
- Prior STEMI
- Patients with regional wall motion abnormalities in the non-infarct region
- Prior CABG or need for CABG
- Patients with significant valve disease; defined as stenosis or regurgitation graded as greater than moderate (2+).
- Patients with clinically apparent, concurrent infection, requiring intravenous antibiotics
- Patients who are or could be pregnant
- Patients with another etiology of LV dysfunction (known/suspected non ischemic cardiomyopathy, previous anthracycline therapy, known ethanol abuse (greater than 6 oz. ethanol/day on a regular basis).
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00394498
Start Date
September 1 2005
End Date
October 1 2006
Last Update
November 1 2006
Active Locations (1)
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1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7