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

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: 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.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

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

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

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

• 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

General 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.

Helpful Links

• Study Sponsor

Study record dates

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: Coronary Artery Disease; Cardiovascular Disease; Atherosclerosis; Coronary Occlusion; Non-Invasive Medical Device; Cardiac Diagnostics
• Additional Relevant MeSH Terms: Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cardiovascular Diseases
• 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