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

Sponsor

AusculSciences Canada Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04562142

Collaborator

Ottawa Heart Institute Research Corporation (Other)

395

Enrollment

Locations

Anticipated Duration (Months)

197.5

Patients Per Site

14.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Cardiovascular Diseases Atherosclerosis Coronary Occlusion	Device: CAD-det	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

395 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

CAD-detCAD-det

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Outcome Measures

Primary Outcome Measures

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

CAD-det to detect: [up to 1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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