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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease, Cardiovascular Disease

Participation Criteria
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Eligibility Criteria
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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; Pregnancy; Skin injury/diseases/lesions that would preclude safe application of the CAD-det device.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants suspected of having Coronary Artery Disease | Collection of all acoustic cardiac data to allow for the acoustic discrimination of the presence and degree of CAD in diseased and healthy participants. | up to 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of coronary artery stenosis by the CAD-det device. | CAD-det results will be categorized by sex as: Acoustic and electrical signals consistent with 0-30% diameter stenosis (Negative for CAD); Acoustic and electrical signals consistent with 31-49% diameter stenosis (Pr-clinical / Negative); Acoustic and electrical signals consistent with 50-69% diameter stenosis (Positive); Acoustic and electrical signals consistent with 70% or greater diameter stenosis (Positive); and Equivocal or non-diagnostic. | up to 1 year | 
| Estimation of coronary artery stenosis by CCTA and ICA categorized by sex as: | 0 - 30% diameter stenosis (Negative); 31 - 49% diameter stenosis (Negative / Pre-clinical); 50 - 69% diameter stenosis (Positive); 70% or greater diameter stenosis (Positive); and Equivocal In cases where a participant undergoes both CCTA and ICA, the ICA results shall serve as the reference method results used for statistical analysis of the diagnostic accuracy of CAD-det. In participants with equivocal ICA and when invasive coronary physiology or functional assessments (eg. FFR, iFR, Pd/Pa, RFR) are performed, these assessments will be used to ascertain if the CAD-det can determine functional (hemodynamically significant) CAD. | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Cardiovascular Disease, Atherosclerosis, Coronary Occlusion, Non-Invasive Medical Device, Cardiac Diagnostics