Clinical trial NCT04562142: A Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease The CAD-det Validation Study
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Cardiovascular Diseases
Atherosclerosis
Coronary Occlusion
Lead sponsor: AusculSciences Canada Inc.
Sponsor class: INDUSTRY
Collaborators: name: Ottawa Heart Institute Research Corporation
First posted: 2020-09-24
Enrollment: 395
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: CAD-det
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: CAD-det to validate:
timeFrame: up to 1 Year
Secondary outcomes:
measure: CAD-det to detect:
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The University of Ottawa Heart Institute
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institue Research Foundation
name: Ben Chow, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Makaryus AN, Makaryus JN, Figgatt A, Mulholland D, Kushner H, Semmlow JL, Mieres J, Taylor AJ. Utility of an advanced digital electronic stethoscope in the diagnosis of coronary artery disease compared with coronary computed tomographic angiography. Am J Cardiol. 2013 Mar 15;111(6):786-92. doi: 10.1016/j.amjcard.2012.11.039. Epub 2013 Jan 1.