Myocardial Infarction Clinical Trial
Official title:
The Effect of Granulocyte Colony Stimulating Factor (G-CSF) on Myocardial Function After Acute Anterior Myocardial Infarction, a Prospective Double Blind Randomized Placebo Controlled Study
The investigators applied G-CSF to patients 2 weeks after acute anterior MI and successful PCI to evaluate the efficacy and safety of G-CSF in improving myocardial function as cytokine which improve inflammation and mobilize stem cells from bone marrow for regeneration of myocardium.
Ten patients in the treatment group and 10 patients in the control group were enrolled in
this prospective, randomized, double blinded study. Two weeks after myocardial infarction
that was accompanied by successful recanalization and stent implantation, the patients of
the treatment group received 10 μg/kg body weight per day (divided BID) G-CSF subcutaneously
for treatment duration of maximum 5.0 days. In both groups, ejection fraction was evaluated
with echocardiography and cardiac scan (Gated SPECT method) 10 days after myocardial
infarction and after 6 months. Tei index was measured by echocardiography.
Results: No severe side effects of G-CSF treatment were observed. Ejection fraction
determined by cardiac scan increased in the treatment group from 0.428 to 0.462 and from
0.470 to 0.496 in the control group but there was no significant improvement of left
ventricular ejection fraction when the G-CSF treated group was compared to the controls
(p=0.821 for cardiac scan and p=0.705 for echocardiography). Changes in Tei index was not
significant in the treatment group (p=0.815) however it reached significant level in the
control group (p=0.005), respectively.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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