Evaluation of the CAD-det System, a Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- AusculSciences Canada Inc.
- Enrollment
- 2000
- Locations
- 3
- Primary Endpoint
- Number of Participants suspected of having Coronary Artery Disease
- Status
- Suspended
- Last Updated
- 5 years ago
Overview
Brief Summary
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).
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Number of Participants suspected of having Coronary Artery Disease
Time Frame: 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.
Secondary Outcomes
- 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)