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临床试验/NCT00756756
NCT00756756已完成不适用

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

Shiraz University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2007年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Ejection fraction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • First anterior myocardial infarction.
  • Low systolic ventricular function.

排除标准

  • Bleeding tendency
  • Contraindication to G-CSF
  • Cardiogenic shock
  • Hemodynamic instability
  • Hepatic or renal disease
  • Multivessel disease

研究组 & 干预措施

1

Experimental

post MI post PCI and G-CSF infusion

干预措施: G-CSF (Drug)

2

Placebo Comparator

post MI and post PCI only placebo infused

干预措施: placebo infusion of normal saline (Drug)

结局指标

主要结局

Ejection fraction

时间窗: 6 months

Diastolic function(Tei index)

时间窗: 6 months

次要结局

  • Drug complication(acute and 6 months)
  • Mortality(6 months)
  • New revascularization and MACE(6 months)

研究者

申办方类型
Other

研究点 (1)

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