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

January 11, 2021 updated by: AusculSciences Canada Inc.
The primary purpose of this multi-center study is to collect and study the acoustic and electrical signals created by the heart during the cardiac cycle as a result of stenosis or plaque associated with coronary artery disease (CAD).

Study Overview

Status

Suspended

Conditions

Detailed Description

This research intends to evaluate acoustic and electrical cardiovascular signals in patients with known or suspected CAD and establish the ability of the CAD-det System to accurately and reliably detect them utilizing coronary computed tomography (CCTA) and invasive coronary angiography (ICA) as reference standards. In addition, this study will collect clinical and acoustic data of other cardiac pathologies to better understand their impact on the acoustic signatures associated with CAD.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

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

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre (University of Calgary)
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L5
        • Horizon Health Network, Saint John Regional Hospital
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • 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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Up to 2,000 men and women age 19 and over with suspected or known CAD referred for clinically indicated Invasive Coronary Angiography (ICA) or Coronary Computed Tomography Angiography (CCTA).

Description

Inclusion Criteria:

  1. Age ≥ 19 years;
  2. Suspected or known CAD;
  3. Able and willing to comply with the study procedures;
  4. Referred to ICA or CCTA for CAD characterization;
  5. Willingness and ability to sign the Informed Consent Form.

Exclusion Criteria:

  1. Unwillingness or inability to provide informed consent;
  2. Age less than 19 years;
  3. Pregnancy;
  4. Skin injury/diseases/lesions that would preclude safe application of the CAD-det device.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants suspected of having Coronary Artery Disease
Time Frame: up to 1 Year
Collection of all acoustic cardiac data to allow for the acoustic discrimination of the presence and degree of CAD in diseased and healthy participants.
up to 1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimation of coronary artery stenosis by the CAD-det device.
Time Frame: up to 1 year

CAD-det results will be categorized by sex as:

  1. Acoustic and electrical signals consistent with 0-30% diameter stenosis (Negative for CAD);
  2. Acoustic and electrical signals consistent with 31-49% diameter stenosis (Pr-clinical / Negative);
  3. Acoustic and electrical signals consistent with 50-69% diameter stenosis (Positive);
  4. Acoustic and electrical signals consistent with 70% or greater diameter stenosis (Positive); and
  5. Equivocal or non-diagnostic.
up to 1 year
Estimation of coronary artery stenosis by CCTA and ICA categorized by sex as:
Time Frame: up to 1 year
  1. 0 - 30% diameter stenosis (Negative);
  2. 31 - 49% diameter stenosis (Negative / Pre-clinical);
  3. 50 - 69% diameter stenosis (Positive);
  4. 70% or greater diameter stenosis (Positive); and
  5. Equivocal

In cases where a participant undergoes both CCTA and ICA, the ICA results shall serve as the reference method results used for statistical analysis of the diagnostic accuracy of CAD-det. In participants with equivocal ICA and when invasive coronary physiology or functional assessments (eg. FFR, iFR, Pd/Pa, RFR) are performed, these assessments will be used to ascertain if the CAD-det can determine functional (hemodynamically significant) CAD.
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

University of Calgary
Hamilton Health Sciences Corporation
Ottawa Heart Institute Research Corporation
Horizon Health Network

Investigators

  • Principal Investigator: Benjamin Chow, MD, FRCP(C), University of Ottawa Heart Institute (UOHI)

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 (Actual)

April 5, 2019

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

January 31, 2019

First Submitted That Met QC Criteria

April 11, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Actual)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAD-det-Research-Study

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

product manufactured in and exported from the U.S.

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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