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

This study has been completed.
Sponsor:
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00756756
First received: September 19, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Myocardial Infarction
Drug: G-CSF
Drug: placebo infusion of normal saline

Study Type: Interventional
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
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

Resource links provided by NLM:


Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • Ejection fraction [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Diastolic function(Tei index) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Drug complication [ Time Frame: acute and 6 months ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • New revascularization and MACE [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: June 2007
Study Completion Date: February 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756756

Locations
Iran, Islamic Republic of
Shiraz University of Medical Sciences/Cardiology Ward/Namazi and Shahid Faghihi Hospital
Shiraz, Fars, Iran, Islamic Republic of, 51318
Sponsors and Collaborators
Shiraz University of Medical Sciences
  More Information

No publications provided

Responsible Party: Kojuri J M.D., Shiraz University of medical sciences
ClinicalTrials.gov Identifier: NCT00756756     History of Changes
Other Study ID Numbers: 86-3454
Study First Received: September 19, 2008
Last Updated: September 19, 2008
Health Authority: Iran: Ministry of Health

Keywords provided by Shiraz University of Medical Sciences:
G-CSF
Myocardial infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Anterior Wall Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014