Evaluation of the CAD-det System, a Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease

AusculSciences

Status: Suspended

Conditions: Coronary Artery Disease; Cardiovascular Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03914079

CAD-det-Research-Study

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 19 years;
2. Suspected or known CAD;
3. Able and willing to comply with the study procedures;
4. Referred to ICA or CCTA for CAD characterization;
5. Willingness and ability to sign the Informed Consent Form.

Exclusion criteria

1. Unwillingness or inability to provide informed consent;
2. Age less than 19 years;
3. Pregnancy;
4. Skin injury/diseases/lesions that would preclude safe application of the CAD-det device.