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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04562142
Recruitment Status : Not yet recruiting
First Posted : September 24, 2020
Last Update Posted : September 24, 2020
Sponsor:
Collaborator:
Ottawa Heart Institute Research Corporation
Information provided by (Responsible Party):
AusculSciences Canada Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Cardiovascular Diseases Atherosclerosis Coronary Occlusion Device: CAD-det Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 395 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: CAD-det
Masking: None (Open Label)
Primary Purpose: Other
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)
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


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

Outcome Measures
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Primary Outcome Measures :
  1. 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%.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04562142


Contacts
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Contact: Melissa Spero, CRN, CCRP 613 763-0088 ext 107 melissa@ausculsciences.com
Contact: John Phillips, BSc. 613 763-0088 john@ausculsciences.com

Locations
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Canada, Ontario
The University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Farrah Ahmed    613-696-7000 ext 12697    fahmed@ottawaheart.ca   
Principal Investigator: Benjamin Chow, MD         
Sub-Investigator: Aun Yeong Chong, MD         
Sponsors and Collaborators
AusculSciences Canada Inc.
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: Ben Chow, MD Ottawa Heart Institue Research Foundation
More Information
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Additional Information:

Publications:

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Responsible Party: AusculSciences Canada Inc.
ClinicalTrials.gov Identifier: NCT04562142    
Other Study ID Numbers: CAD-det Validation
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
 Coronary Occlusion
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases