Subcutaneous Administration of Pegylated Granulocyte-Colony Stimulating Factor for Long-Term 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)
研究概览
简要总结
The purpose of this study in patients with stable coronary artery disease (CAD) treatable by PCI (percutaneous coronary intervention) is to evaluate the long-term efficacy and safety of subcutaneously applied, pegylated granulocyte colony stimulating factor (Pegfilgrastim, PEG-G-CSF; Neulasta®, Amgen Switzerland) with regard to the promotion of collateral growth.
详细描述
Coronary artery disease (CAD) is the leading cause of death in industrialized countries. Current revascularization therapies are PCI or surgical revascularization. However, inherent to them are procedure-related risks and the fact, that progression of CAD is not prevented. Additionally, up to one fourth of all CAD patients are not amenable to standard revascularization therapies. Thus, there is a need for alternative therapies. The coronary collateral circulation is prevalent in humans, and in CAD the amount of collateral flow is a pivotal protective factor with respect to infarct size, all-cause- and cardiac mortality. Coronary collateral growth promotion is an alternative to conventional revascularization which can be achieved by cytokine-based approaches (e.g. with colony-stimulating factor-therapy) in humans. The goal of collateral promotion is to reduce myocardial damage in case of a coronary occlusion.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •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)
时间窗: 6 months
次要结局
- Myocardial blood flow (MBF) during hyperemia(6 months)
