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

September 19, 2008 updated by: Shiraz University of Medical Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Fars
      • Shiraz, Fars, Iran, Islamic Republic of, 51318
        • Shiraz University of Medical Sciences/Cardiology Ward/Namazi and Shahid Faghihi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
post MI post PCI and G-CSF infusion
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 Comparator: 2
post MI and post PCI only placebo infused
Drug: placebo infusion of normal saline
2 week post MI and PCI normal saline was infused

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ejection fraction
Time Frame: 6 months
6 months
Diastolic function(Tei index)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 6 months
6 months
Drug complication
Time Frame: acute and 6 months
acute and 6 months
New revascularization and MACE
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

September 19, 2008

First Submitted That Met QC Criteria

September 19, 2008

First Posted (Estimate)

September 22, 2008

Study Record Updates

Last Update Posted (Estimate)

September 22, 2008

Last Update Submitted That Met QC Criteria

September 19, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 86-3454

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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