Subcutaneous Delivery of Filgrastim (rG-CSF) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Collateral flow index (CFI) at 2 weeks follow-up compared to baseline CFI
研究概览
简要总结
The purpose of this study in humans with stable coronary artery disease (CAD) treatable by PCI (percutaneous coronary intervention) is to evaluate the safety and efficacy of subcutaneous delivery of recombinant granulocyte colony stimulating factor rG-CSF (Filgrastim, Neupogen®, Amgen Switzerland) with regard to the promotion of collateral growth.
详细描述
The purpose of this study in humans with stable coronary artery disease (CAD) treatable by PCI (percutaneous coronary intervention) is to evaluate the safety and efficacy of subcutaneous delivery of recombinant granulocyte colony stimulating factor rG-CSF (Filgrastim, Neupogen®, Amgen Switzerland) with regard to the promotion of collateral growth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •1- to 3-vessel coronary artery disease (CAD)
- •Stable angina pectoris
- •At least 1 stenotic lesion suitable for PCI
- •No Q-wave myocardial infarction in the area undergoing CFI measurement
- •Written informed consent to participate in the study
排除标准
- •Patients admitted as emergencies
- •Acute myocardial infarction
- •Unstable CAD
- •CAD treated best by CABG
- •Patients with overt neoplastic disease
- •Patients with diabetic retinopathy
- •Liver or kidney disease
- •Pre-menopausal women
结局指标
主要结局
Collateral flow index (CFI) at 2 weeks follow-up compared to baseline CFI
次要结局
- Absolute myocardial perfusion during hyperemia by contrast echocardiography (MCE) at baseline, at 2 weeks and at 6 month follow-up