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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756756
• Other study ID #: 86-3454
• Status: Completed
• Phase: N/A
• First received: September 19, 2008
• Last updated: September 19, 2008
• Start date: June 2007
• Est. completion date: February 2008

Study information

• Verified date: September 2008
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Wall Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• G-CSF
after 2 week post MI an d PCI G-CSF was infused for 5 days at dose of 10 microgram/Kg
• placebo infusion of normal saline
2 week post MI and PCI normal saline was infused

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shiraz University of Medical Sciences/Cardiology Ward/Namazi and Shahid Faghihi Hospital	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ejection fraction		6 months	Yes
Primary	Diastolic function(Tei index)		6 months	Yes
Secondary	Drug complication		acute and 6 months	Yes
Secondary	Mortality		6 months	Yes
Secondary	New revascularization and MACE		6 months	Yes