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Completed

NCT Number: NCT00756756

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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shiraz University of Medical Sciences/Cardiology Ward/Namazi and Shahid Faghihi Hospital

Shiraz, Fars, 51318, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

G-CSF

Drug

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

Drug

2 week post MI and PCI normal saline was infused

Primary outcomes

  1. Ejection fraction

    Time frame: 6 months

  2. Diastolic function(Tei index)

    Time frame: 6 months

Secondary outcomes

  1. Drug complication

    Time frame: acute and 6 months

  2. Mortality

    Time frame: 6 months

  3. New revascularization and MACE

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Sep 22, 2008
Registry last updated
Sep 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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