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Stem Cell Mobilization by G-CSF by Granulocyte Colony Stimulating Factor Post Myocardial Infarction to Promote Myocyte Repair


Phase 2/Phase 3
40 Years
75 Years
Open (Enrolling)
Both
Myocardial Infarction

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Trial Information

Stem Cell Mobilization by G-CSF by Granulocyte Colony Stimulating Factor Post Myocardial Infarction to Promote Myocyte Repair


Inclusion Criteria:



1. 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.

2. Age between 40 -75 years

3. 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.

4. Eligible for treatment with G-CSF within the 5 days Post AMI.

Exclusion Criteria:

1. Prior STEMI

2. Patients with regional wall motion abnormalities in the non-infarct region

3. Prior CABG or need for CABG

4. Patients with significant valve disease; defined as stenosis or regurgitation graded
as greater than moderate (2+).

5. Patients with clinically apparent, concurrent infection, requiring intravenous
antibiotics

6. Patients who are or could be pregnant

7. 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).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

6 month Left ventricular ejection fraction

Principal Investigator

Chris A Glover, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Ottawa Heart Institute

Authority:

Canada: Health Canada

Study ID:

135287

NCT ID:

NCT00394498

Start Date:

September 2005

Completion Date:

October 2006

Related Keywords:

  • Myocardial Infarction
  • Myocardial Infarction
  • Stem Cells
  • Infarction
  • Myocardial Infarction

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