Data Acquisition for Optimization of Coronary Artery Disease Algorithm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- The Area Under the Receiver Operating Characteristic Curve of the CAD-score to Separate CAD From Non-CAD Patients.
研究概览
简要总结
The purpose of the study is to optimize an already existing algorithm for diagnosing atherosclerosis of the coronary arteries (CAD, Coronary Artery Disease).
详细描述
Acoustic information from the heart is obtained from patients referred to examination for Coronary Artery Disease. The acoustic signals are evaluated as indicators for CAD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old
- •Referred to diagnostically Ca-CT, CT scan and/or CAG examination due to suspicion of coronary artery disease
- •Subjects condition must be stable and the subject must not be referred due to suspicion of acute coronary syndrome
- •Subject is willing to adhere to the study procedure
- •Has signed the informed consent form and authorization to registration and publication of health information
排除标准
- •Has acute coronary syndrome or stroke
- •Arterial fibrillation
- •Known severe arrhythmia or resting heart rate above 85 bpm
- •Known diastolic murmurs due to heart valve disease
- •Has had a previous by-pass operation, open chest surgery, donor heart or mechanical heart
- •Reduced ejection fraction < 50%
- •Inability to understand or adhere to instructions for acoustic Data-acquisition (i.e. subject not able to hold breath due to KOL or asthma)
- •Inability to perform CT-angio and/or subsequent CAG
- •In active treatment for any cancer
- •In active treatment for immunosuppression after transplantation
- •Established or pursuing pregnancy or breast feeding
- •Has damaged skin on the spot where the patch is placed during the recordings.
结局指标
主要结局
The Area Under the Receiver Operating Characteristic Curve of the CAD-score to Separate CAD From Non-CAD Patients.
时间窗: Heart sound recordings measured on testday (25 minutes study period)
Cardiac noise marker (CAD-score) ability to separate CAD from non-CAD patients is estimated as the area under the receiver operating characteristic curve. The area under the receiver operating characteristic curve is plottet as sensitivity versus 1-specificity as a function of different CAD-score cut-off values. The area under the receiver operating characteristic curve is on a scale from 0-100%, the higher value means a better separation of CAD from non-CAD patients. CAD and non-CAD patients are defined by the CTA and CAG evaluations.
次要结局
未报告次要终点