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Stem Cell Mobilization by G-CSF Post Myocardial Infarction to Promote Myocyte Repair

Primary Purpose

Myocardial Infarction

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Granulocyte Colony Stimulating Factor
Sponsored by
University of Ottawa
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial Infarction, Stem Cells

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Ottawa Heart InstituteRecruiting

Outcomes

Primary Outcome Measures

6 month Left ventricular ejection fraction

Secondary Outcome Measures

6 week left ventricular ejection fraction
6 week myocardial FDG-PET uptake
6 week myocardial Ammonia-PET perfusion
6 week/month left ventricular diastolic volume
6 week/month left ventricular systolic volume

Full Information

First Posted
October 30, 2006
Last Updated
October 30, 2006
Sponsor
University of Ottawa
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT00394498
Brief Title
Stem Cell Mobilization by G-CSF Post Myocardial Infarction to Promote Myocyte Repair
Official Title
Stem Cell Mobilization by G-CSF by Granulocyte Colony Stimulating Factor Post Myocardial Infarction to Promote Myocyte Repair
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Ottawa
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

5. Study Description

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 parameters using nuclear cardiology scans that are used in everyday cardiology practice. The patients will then be divided into 2 groups. One group will receive a medication called G-CSF and the other group will receive a placebo. We will give this drug (1-2ml) for 4 days beneath the skin. We will take the patients blood during this time and measure how the drug affected their blood. The patients will all have the nuclear cardiology tests again in 6 weeks and 6 months to see how their heart is functioning. As well, they will have a six month angiogram. All the patients will otherwise receive optimal care from their Cardiologist. They will be seen at 6, 12, 24, and 52 weeks to assess them clinically. This study will test the effects of G-CSF on the heart function of patients who have had a heart attack. It is a medication that that has been shown in an animal model to improve heart function after a heart attack. It is a medication that has been used for many years to treat patients with cancers and to increase the number of cells donated by healthy bone marrow donors. It has no serious side effects. It works by increasing the number of a person's own stem cells in the blood. Stem cells are special cells that are present in our bodies that have the ability to form new cells. It had been thought that the heart could not make new cells after it has been damaged. Other investigators have shown that this might not be the case. It is now thought that after an injury, stem cells from the bone marrow can transform into cells of the injured tissue. Therefore, we are trying to increase the number of stem cells in the circulation with G-CSF so as to increase repair in the heart after it has been damaged. This strategy has never been tried in human beings and if successful could greatly reduce death and suffering from heart disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Myocardial Infarction, Stem Cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
86 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Granulocyte Colony Stimulating Factor
Primary Outcome Measure Information:
Title
6 month Left ventricular ejection fraction
Secondary Outcome Measure Information:
Title
6 week left ventricular ejection fraction
Title
6 week myocardial FDG-PET uptake
Title
6 week myocardial Ammonia-PET perfusion
Title
6 week/month left ventricular diastolic volume
Title
6 week/month left ventricular systolic volume

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chris A Glover, MD
Phone
613-761-4119
Email
cglover@ottawaheart.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris A Glover, MD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
24934893
Citation
Hibbert B, Hayley B, Beanlands RS, Le May M, Davies R, So D, Marquis JF, Labinaz M, Froeschl M, O'Brien ER, Burwash IG, Wells GA, Pourdjabbar A, Simard T, Atkins H, Glover C. Granulocyte colony-stimulating factor therapy for stem cell mobilization following anterior wall myocardial infarction: the CAPITAL STEM MI randomized trial. CMAJ. 2014 Aug 5;186(11):E427-34. doi: 10.1503/cmaj.140133. Epub 2014 Jun 16.
Results Reference
derived
PubMed Identifier
21567283
Citation
Anselm DD, Anselm AH, Renaud J, Atkins HL, de Kemp R, Burwash IG, Williams KA, Guo A, Kelly C, Dasilva J, Beanlands RS, Glover CA. Altered myocardial glucose utilization and the reverse mismatch pattern on rubidium-82 perfusion/F-18-FDG PET during the sub-acute phase following reperfusion of acute anterior myocardial infarction. J Nucl Cardiol. 2011 Aug;18(4):657-67. doi: 10.1007/s12350-011-9389-5. Epub 2011 May 13.
Results Reference
derived

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Stem Cell Mobilization by G-CSF Post Myocardial Infarction to Promote Myocyte Repair

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