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

Shiraz University of Medical Sciences

Status: Completed

Conditions: Myocardial Infarction

Treatments: Drug: G-CSF; Drug: placebo infusion of normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00756756

86-3454

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

post MI post PCI and G-CSF infusion

Treatment:

Drug: G-CSF

2

Placebo Comparator group

Description:

post MI and post PCI only placebo infused

Treatment:

Drug: placebo infusion of normal saline