Validation of the CAD-det System, a Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease (The CAD-det Validation Study)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- AusculSciences Canada Inc.
- Enrollment
- 395
- Locations
- 2
- Primary Endpoint
- CAD-det to validate:
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\>/= 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
- •Unwillingness or inability to provide informed consent or to comply with the study protocol
Outcomes
Primary Outcomes
CAD-det to validate:
Time Frame: up to 1 Year
CAD-det to detect obstructive CAD as defined as QCA diameter stenosis greater than or equal to 50%.
Secondary Outcomes
- CAD-det to detect:(up to 1 year)