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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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
G-CSF
placebo infusion of normal saline
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring G-CSF, Myocardial infarction

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

post MI post PCI and G-CSF infusion

post MI and post PCI only placebo infused

Outcomes

Primary Outcome Measures

Ejection fraction
Diastolic function(Tei index)

Secondary Outcome Measures

Drug complication
Mortality
New revascularization and MACE

Full Information

First Posted
September 19, 2008
Last Updated
September 19, 2008
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00756756
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
G-CSF, Myocardial infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
post MI post PCI and G-CSF infusion
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
post MI and post PCI only placebo infused
Intervention Type
Drug
Intervention Name(s)
G-CSF
Intervention Description
after 2 week post MI an d PCI G-CSF was infused for 5 days at dose of 10 microgram/Kg
Intervention Type
Drug
Intervention Name(s)
placebo infusion of normal saline
Intervention Description
2 week post MI and PCI normal saline was infused
Primary Outcome Measure Information:
Title
Ejection fraction
Time Frame
6 months
Title
Diastolic function(Tei index)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Drug complication
Time Frame
acute and 6 months
Title
Mortality
Time Frame
6 months
Title
New revascularization and MACE
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Shiraz University of Medical Sciences/Cardiology Ward/Namazi and Shahid Faghihi Hospital
City
Shiraz
State/Province
Fars
ZIP/Postal Code
51318
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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