Myocardial Infarction
Conditions
Keywords
G-CSF, Myocardial infarction
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.
Interventions
DRUGG-CSF
after 2 week post MI an d PCI G-CSF was infused for 5 days at dose of 10 microgram/Kg
DRUGplacebo infusion of normal saline
2 week post MI and PCI normal saline was infused
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ejection fraction | 6 months |
| Diastolic function(Tei index) | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Drug complication | acute and 6 months |
| Mortality | 6 months |
| New revascularization and MACE | 6 months |
Countries
Iran
Outcome results
None listed