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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03914079
Recruitment Status : Suspended (Sponsor due to COVID-19)
First Posted : April 16, 2019
Last Update Posted : September 21, 2020
Sponsor:
Collaborators:
Ottawa Heart Institute Research Corporation
Horizon Health Network
University of Calgary
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
AusculSciences Canada Inc.

Brief Summary:
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).

Condition or disease
Coronary Artery Disease Cardiovascular Disease

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Evaluation of the CAD-det System, a Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease
Actual Study Start Date : April 5, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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.

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): NCT03914079


Locations
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Canada, Alberta
Foothills Medical Centre (University of Calgary)
Calgary, Alberta, Canada, T2N 2T9
Canada, New Brunswick
Horizon Health Network, Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L5
Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
AusculSciences Canada Inc.
Ottawa Heart Institute Research Corporation
Horizon Health Network
University of Calgary
Hamilton Health Sciences Corporation
Investigators
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Principal Investigator: Benjamin Chow, MD, FRCP(C) University of Ottawa Heart Institute (UOHI)
Additional Information:
Publications:
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Responsible Party: AusculSciences Canada Inc.
ClinicalTrials.gov Identifier: NCT03914079    
Other Study ID Numbers: CAD-det-Research-Study
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: September 21, 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
Keywords provided by AusculSciences Canada Inc.:
Coronary Artery Disease
Cardiovascular Disease
Atherosclerosis
Coronary Occlusion
Non-Invasive Medical Device
Cardiac Diagnostics
Additional relevant MeSH terms:
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Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases