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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)

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ClinicalTrials.gov Identifier: NCT03914079
Recruitment Status : Suspended (Sponsor due to COVID-19)
First Posted : April 16, 2019
Last Update Posted : June 11, 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.

Tracking Information
First Submitted Date January 31, 2019
First Posted Date April 16, 2019
Last Update Posted Date June 11, 2020
Actual Study Start Date April 5, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 16, 2019)
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.
Original Primary Outcome Measures
 (submitted: April 11, 2019)
Coronary Stenosis [ Time Frame: ~ 1 Year ]
Collection of all acoustic and electrical cardiac data along with other clinical data to allow for the acoustic / electrical discrimination of the presence and degree of CAD in diseased and healthy participants.
Change History
Current Secondary Outcome Measures
 (submitted: April 16, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: April 11, 2019)
  • Estimation of coronary artery stenosis by the CAD-det device. [ Time Frame: ~ 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.
  • Estimation of coronary artery stenosis by CCTA and ICA categorized by sex as: [ Time Frame: ~ 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of the CAD-det System, a Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease
Official Title Evaluation of the CAD-det System, a Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease
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).
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
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).
Condition
  • Coronary Artery Disease
  • Cardiovascular Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Suspended
Estimated Enrollment
 (submitted: April 11, 2019)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03914079
Other Study ID Numbers CAD-det-Research-Study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party AusculSciences Canada Inc.
Study Sponsor AusculSciences Canada Inc.
Collaborators
  • Ottawa Heart Institute Research Corporation
  • Horizon Health Network
  • University of Calgary
  • Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Benjamin Chow, MD, FRCP(C) University of Ottawa Heart Institute (UOHI)
PRS Account AusculSciences Canada Inc.
Verification Date June 2020