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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: G-CSF
* Drug: placebo infusion of normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First anterior myocardial infarction. Low systolic ventricular function. Exclusion Criteria: Bleeding tendency Contraindication to G-CSF Cardiogenic shock Hemodynamic instability Hepatic or renal disease Multivessel disease

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>post MI post PCI and G-CSF infusion | Drug: G-CSF<br>* after 2 week post MI an d PCI G-CSF was infused for 5 days at dose of 10 microgram/Kg<br>|
| Placebo Comparator: 2<br>post MI and post PCI only placebo infused | Drug: placebo infusion of normal saline<br>* 2 week post MI and PCI normal saline was infused<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ejection fraction |  | 6 months | 
| Diastolic function(Tei index) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug complication |  | acute and 6 months | 
| Mortality |  | 6 months | 
| New revascularization and MACE |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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G-CSF, Myocardial infarction