Myocardial Infarction Clinical Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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