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

Not Applicable

• Conditions: Cardiovascular Diseases; Coronary Artery Disease; Atherosclerosis; Coronary Occlusion

• Registration Number: NCT04562142
• Lead Sponsor: AusculSciences Canada Inc.

Brief Summary

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

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.

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-18
• Study First Submitted QC: 2020-09-18
• Last Update Submitted: 2020-09-18
• Study First Posted: 2020-09-24
• Last Update Posted: 2020-09-24
• Study Start: 2021-03
• Primary Completion: 2022-03
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 395

Inclusion Criteria

1. Stable
2. >/= 19 years old
3. Suspected obstructive CAD
4. Referred to ICA

Exclusion Criteria

1. Documented CAD or coronary revascularization
2. Age < 19 years old
3. Acute coronary syndromes
4. Congenital heart disease or heart transplantation
5. Dextrocardia
6. Uncontrolled irregular heart rhythm (atrial arrhythmia (fibrillation, flutter) or frequent PACs or PVCs (>10/minute))
7. Resting heart rate > 110 bpm
8. Known hemodynamically-significant valvular heart disease, audible diastolic murmurs, or hypertrophic or non-ischemic cardiomyopathy
9. Chest wall deformity or wounds in adhesive application areas
10. Pregnancy
11. Unwillingness or inability to provide informed consent or to comply with the study protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
CAD-det to validate:	up to 1 Year	CAD-det to detect obstructive CAD as defined as QCA diameter stenosis greater than or equal to 50%.

Secondary Outcome Measures

Name	Time	Method
CAD-det to detect:	up to 1 year	1. Obstructive CAD as defined as QCA diameter stenosis greater than or equal to 50% stratified according to sex (men and women).; 2. Severity of CAD by QCA: 1. 0 - 25% diameter stenosis (Negative for obstructive CAD); 2. 25 - 50% diameter stenosis (Negative for obstructive CAD); 3. 50 - 69% diameter stenosis (Positive for obstructive CAD); 4. 70% or greater diameter stenosis (Positive for obstructive CAD); and; 5. Equivocal or non-diagnostic.

Trial Locations

Locations (2)

The University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada