Evaluation of the CAD-det System, a Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 2,000
- 试验地点
- 3
- 主要终点
- Number of Participants suspected of having Coronary Artery Disease
研究概览
简要总结
The primary purpose of this multi-center study is to collect and study the acoustic and electrical signals created by the heart during the cardiac cycle as a result of stenosis or plaque associated with coronary artery disease (CAD).
详细描述
This research intends to evaluate acoustic and electrical cardiovascular signals in patients with known or suspected CAD and establish the ability of the CAD-det System to accurately and reliably detect them utilizing coronary computed tomography (CCTA) and invasive coronary angiography (ICA) as reference standards. In addition, this study will collect clinical and acoustic data of other cardiac pathologies to better understand their impact on the acoustic signatures associated with CAD.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 19 years;
- •Suspected or known CAD;
- •Able and willing to comply with the study procedures;
- •Referred to ICA or CCTA for CAD characterization;
- •Willingness and ability to sign the Informed Consent Form.
排除标准
- •Unwillingness or inability to provide informed consent;
- •Age less than 19 years;
- •Skin injury/diseases/lesions that would preclude safe application of the CAD-det device.
结局指标
主要结局
Number of Participants suspected of having Coronary Artery Disease
时间窗: up to 1 Year
Collection of all acoustic cardiac data to allow for the acoustic discrimination of the presence and degree of CAD in diseased and healthy participants.
次要结局
- Estimation of coronary artery stenosis by the CAD-det device.(up to 1 year)
- Estimation of coronary artery stenosis by CCTA and ICA categorized by sex as:(up to 1 year)