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NCT04562142 Clinical Trial

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

Coronary Artery Disease Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04562142
Other study ID # CAD-det Validation
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2021
Est. completion date May 2022

Study information
Verified date September 2020
Source AusculSciences Canada Inc.
Contact Melissa Spero, CRN, CCRP
Phone 613 763-0088
Email melissa@ausculsciences.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 395
Est. completion date May 2022
Est. primary completion date March 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years to 100 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Canada The University of Ottawa Heart Institute Ottawa Ontario
Canada University of Ottawa Heart Institute Ottawa Ontario

Sponsors (2)
Lead Sponsor Collaborator
AusculSciences Canada Inc. Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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