跳至主要内容
临床试验/NCT00886509
NCT00886509已完成不适用

Subcutaneous Administration of Pegylated Granulocyte-Colony Stimulating Factor for Long-Term Promotion of Collateral Growth in Patients With Coronary Artery Disease

Insel Gruppe AG, University Hospital Bern2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年3月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验