Comparison of a Pulse Wave Based Approach for Detection of Coronary Artery Disease Compared to Standard Methods
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Presence of CAD - angio (minimum 1 stenosis >=50%)
研究概览
简要总结
This is a validation study comparing a pulse wave based algorithm for the detection of coronary artery disease with parameters from coronary angiography, echocardiography and cardiogoniometry.
详细描述
The study will validate a pulse wave based algorithm for the detection of coronary artery disease (CAD) with parameters from standard methods. Subjects will be patients admitted to coronary angiography due to suspected CAD. Pulse wave signals will be analyzed according to novelly established algorithm regarding the presence of CAD and/or myocardial ischemia. These results be compared to the diagnoses made by coronary angiography (primary endpoint): presence of minimum one coronary artery stenose >=50%. For secondary analyses, results will be compared to parameters form echocardiography and cardiogoniometry.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Coronary angiography indication present
- •informed written consent
排除标准
- •Previous coronary angiography
- •Known CAD (history of coronary angioplasty, stent implantation and/or bypass surgery)
- •atrial fibrillation (at time of measurement)
- •severe ventricular extrasystole (e.g. >=10% ventricular extrasystoles, bigemina)
- •pregnancy, lactation
结局指标
主要结局
Presence of CAD - angio (minimum 1 stenosis >=50%)
时间窗: 1 day
Presence of CAD in coronary angiography: minimum 1 stenosis \>=50%
次要结局
- Wall motion abnormality - echo (Presence of wall motion abnormality in at least 1 segment (2D echocardiography)(1 day)
- Wall motion index - echo (Wall motion index (2D and 3D echocardiography)(1 day)
- Presence of CAD number - angio (Number of coronary vessels with at least 1 stenosis >=50% in coronary angiography)(1 day)
- Global longitudinal strain (2D and 3D echocardiography)(1 day)
- Abnormal cardiogoniometry(1 day)
研究者
Marcus Doerr
Professor
University Medicine Greifswald