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

Primary Purpose

Coronary Artery Disease, Cardiovascular Diseases, Atherosclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CAD-det
Sponsored by
AusculSciences Canada Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Coronary Artery Disease

Eligibility Criteria

19 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Ottawa Heart Institute
  • University of Ottawa Heart Institute

Outcomes

Primary Outcome Measures

CAD-det to validate:
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:
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.

Full Information

First Posted
September 18, 2020
Last Updated
September 18, 2020
Sponsor
AusculSciences Canada Inc.
Collaborators
Ottawa Heart Institute Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04562142
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AusculSciences Canada Inc.
Collaborators
Ottawa Heart Institute Research Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Cardiovascular Diseases, Atherosclerosis, Coronary Occlusion

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
CAD-det
Masking
None (Open Label)
Allocation
N/A
Enrollment
395 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
CAD-det
Intervention Description
CAD-det test will be done on participants with suspected CAD clinically referred for ICA at a participating clinical investigation site.
Primary Outcome Measure Information:
Title
CAD-det to validate:
Description
CAD-det to detect obstructive CAD as defined as QCA diameter stenosis greater than or equal to 50%.
Time Frame
up to 1 Year
Secondary Outcome Measure Information:
Title
CAD-det to detect:
Description
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.
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa Spero, CRN, CCRP
Phone
613 763-0088
Ext
107
Email
melissa@ausculsciences.com
First Name & Middle Initial & Last Name or Official Title & Degree
John Phillips, BSc.
Phone
613 763-0088
Email
john@ausculsciences.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Chow, MD
Organizational Affiliation
Ottawa Heart Institue Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farrah Ahmed
Phone
613-696-7000
Ext
12697
Email
fahmed@ottawaheart.ca
First Name & Middle Initial & Last Name & Degree
Benjamin Chow, MD
First Name & Middle Initial & Last Name & Degree
Aun Yeong Chong, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23290309
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.
Results Reference
background
Links:
URL
http://ausculsciences.com
Description
Study Sponsor

Learn more about this trial

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

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