Validation of the CAD-det System, a Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease (The CAD-det Validation Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 395
- 试验地点
- 4
- 主要终点
- CAD-det to validate:
研究概览
简要总结
The purpose of the study is to collect acoustic, ECG, and clinical data from consenting participants, so that AusculSciences can perform analysis on the sounds produced by the heart and determine the accuracy of the CAD-det System for detecting CAD.
详细描述
This is a prospective multi-center clinical trial. Using the CAD-det, acoustic and electrical cardiac data will be collected from participants with intermediate pretest probability of CAD who are referred to invasive coronary angiography (ICA). The CAD-det recording will be administered prior to the scheduled ICA procedure. The data collected by CAD-det will be processed using AusculSciences' Data Analysis Application (DAA) to produce a patient's indication for CAD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>/= 19 years old
- •Suspected obstructive CAD
- •Referred to ICA
排除标准
- •Documented CAD or coronary revascularization
- •Age < 19 years old
- •Acute coronary syndromes
- •Congenital heart disease or heart transplantation
- •Dextrocardia
- •Uncontrolled irregular heart rhythm (atrial arrhythmia (fibrillation, flutter) or frequent PACs or PVCs (>10/minute))
- •Resting heart rate > 110 bpm
- •Known hemodynamically-significant valvular heart disease, audible diastolic murmurs, or hypertrophic or non-ischemic cardiomyopathy
- •Chest wall deformity or wounds in adhesive application areas
- •Unwillingness or inability to provide informed consent or to comply with the study protocol
结局指标
主要结局
CAD-det to validate:
时间窗: up to 1 Year
CAD-det to detect obstructive CAD as defined as QCA diameter stenosis greater than or equal to 50%.
次要结局
- CAD-det to detect:(up to 1 year)