Stem Cell Mobilization by G-CSF Post Myocardial Infarction to Promote Myocyte Repair
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00394498|
Recruitment Status : Unknown
Verified October 2006 by University of Ottawa.
Recruitment status was: Recruiting
First Posted : November 1, 2006
Last Update Posted : November 1, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction||Drug: Granulocyte Colony Stimulating Factor||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||86 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Stem Cell Mobilization by G-CSF by Granulocyte Colony Stimulating Factor Post Myocardial Infarction to Promote Myocyte Repair|
|Study Start Date :||September 2005|
|Study Completion Date :||October 2006|
- 6 month Left ventricular ejection fraction
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394498
|Contact: Chris A Glover, MDemail@example.com|
|University of Ottawa Heart Institute||Recruiting|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Principal Investigator:||Chris A Glover, MD||Ottawa Heart Institute Research Corporation|