Endothelial Function and Heart Rate Variability After Stenting in Coronary Arteries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- clinical restenosis, major cardiovascular event
研究概览
简要总结
The objective of this study is to evaluate whether impaired endothelial function and low heart rate variability are associated with clinical restenosis after percutaneous coronary intervention with stent implantation in patients with angina or acute coronary syndrome.
Furthermore, the study examines a potential correlation between biomarkers of endothelial cell activation and endothelial dysfunction.
详细描述
Background Atherosclerosis is a chronic, systemic and diffusely distributed disease causing focal complications in different vascular beds.
Impaired endothelial function is the initial step in the progressive course of atherosclerosis . Endothelial dysfunction is considered a systemic process and both coronary and peripheral endothelial dysfunction have been shown to be independently associated with cardiovascular events .
Percutanenous coronary intervention (PCI) with implantation of stent is the treatment of choice in symptomatic stenotic coronary artyery disease (CAD), but in-stent restenosis and progression of disease remains its main limitation. Early identification of patients at risk of restenosis after PCI would therefore be of clinical value. There is only limited prospective data on the role of peripheral endothelial dysfunction after PCI predicting restenosis and cardiovascular events , , .
Furthermore, it is unknown if peripheral endothelial dysfunction is associated with increased levels of biomarkers of endothelial cell activation in this population.
There are conflicting data on inflammatory markers as high-sensitivity CRP with regard to endothelial function.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients after successful revascularization by percutaneous coronary intervention with stent implantation for single coronary artery disease
排除标准
- •Multivessel coronary artery disease
- •Left ventricular dysfunction defined as ejection fraction (EF) < 50%
- •Former aortocoronary bypass-surgery
- •Systemic inflammatory diseases other than atherosclerosis
- •inability to give informed consent
- •Renal failure (kreatinin > 250 mmol/l)
- •Refusion to participate
结局指标
主要结局
clinical restenosis, major cardiovascular event
时间窗: 12 months
次要结局
- endothelial function, heart rate variability(12 months)