Myocardial InfarctionPhase 2/3NCT00394498
Stem Cell Mobilization by G-CSF Post Myocardial Infarction to Promote Myocyte Repair
A Phase 2/3 study testing Granulocyte Colony Stimulating Factor in people with Myocardial Infarction, run by University of Ottawa at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Granulocyte Colony Stimulating Factor
- How many people
- 86 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to Oct 2006
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
About this study
Official title: Stem Cell Mobilization by G-CSF by Granulocyte Colony Stimulating Factor Post Myocardial Infarction to Promote Myocyte Repair
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.
- Conditions
- Myocardial Infarction
- Being tested
- Granulocyte Colony Stimulating Factor
- Keywords
- Myocardial Infarction, Stem Cells
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granulocyte Colony Stimulating FactorDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
6 month Left ventricular ejection fraction
Secondary outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2006 (estimated)
- Study startSep 2005
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 86 participants
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Chris A Glover, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394498
- Sponsor's protocol ID
- 135287
- Status last verified
- Oct 2006
- First submitted
- 30 Oct 2006
- Last updated
- 1 Nov 2006
- Results posted
- No
Publications
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.
PubMed 24934893Anselm 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.
PubMed 21567283
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stem Cell Mobilization by G-CSF by Granulocyte Colony Stimulating Factor Post Myocardial Infarction to Promote Myocyte Repair
- ClinicalTrials.gov ID
- NCT00394498
- Acronym / sponsor ID
- 135287
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial Infarction, Stem Cells
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2005
- Study completion
- Oct 2006
- First posted
- 1 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Granulocyte Colony Stimulating Factor | Drug | – |
Primary outcome
6 month Left ventricular ejection fraction
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2006.
- Derived from this study: PubMed 24934893Hibbert 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.
- Derived from this study: PubMed 21567283Anselm 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris A Glover, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Granulocyte Colony Stimulating Factor in people with Myocardial Infarction, run by University of Ottawa at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chris A Glover, MD (613-761-4119, cglover@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 month Left ventricular ejection fraction. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00394498, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2006.