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

September 18, 2020 updated by: AusculSciences Canada Inc.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

395

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute
        • Contact:
        • Principal Investigator:
          • Benjamin Chow, MD
        • Sub-Investigator:
          • Aun Yeong Chong, MD
      • Ottawa, Ontario, Canada, K1Y 4W7
        • The University of Ottawa Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
up to 1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CAD-det to detect:
Time Frame: up to 1 year
  1. Obstructive CAD as defined as QCA diameter stenosis greater than or equal to 50% stratified according to sex (men and women).

  2. Severity of CAD by QCA:

    1. 0 - 25% diameter stenosis (Negative for obstructive CAD);
    2. 25 - 50% diameter stenosis (Negative for obstructive CAD);
    3. 50 - 69% diameter stenosis (Positive for obstructive CAD);
    4. 70% or greater diameter stenosis (Positive for obstructive CAD); and
    5. Equivocal or non-diagnostic.
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AusculSciences Canada Inc.

Collaborators

Ottawa Heart Institute Research Corporation

Investigators

  • Principal Investigator: Ben Chow, MD, Ottawa Heart Institue Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

September 18, 2020

First Submitted That Met QC Criteria

September 18, 2020

First Posted (Actual)

September 24, 2020

Study Record Updates

Last Update Posted (Actual)

September 24, 2020

Last Update Submitted That Met QC Criteria

September 18, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAD-det Validation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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