A Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease The CAD-det Validation Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Validation of the CAD-det System, a Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease (The CAD-det Validation Study)

Conditions
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Coronary Artery Disease, Cardiovascular Diseases, Atherosclerosis, Coronary Occlusion

Intervention / Treatment
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* Device: CAD-det


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable >/= 19 years old Suspected obstructive CAD Referred to ICA Exclusion Criteria: 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 Pregnancy Unwillingness or inability to provide informed consent or to comply with the study protocol

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 100 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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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: CAD-det
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CAD-det|CAD-det test will be done on participants with suspected CAD clinically referred for ICA at a participating clinical investigation site.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAD-det to validate: | CAD-det to detect obstructive CAD as defined as QCA diameter stenosis greater than or equal to 50%. | up to 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAD-det to detect: | Obstructive CAD as defined as QCA diameter stenosis greater than or equal to 50% stratified according to sex (men and women). Severity of CAD by QCA: 0 - 25% diameter stenosis (Negative for obstructive CAD); 25 - 50% diameter stenosis (Negative for obstructive CAD); 50 - 69% diameter stenosis (Positive for obstructive CAD); 70% or greater diameter stenosis (Positive for obstructive CAD); and Equivocal or non-diagnostic. | up to 1 year |