Clinical trial NCT03914079: 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
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Coronary Artery Disease
Cardiovascular Disease
Keywords: Coronary Artery Disease
Cardiovascular Disease
Atherosclerosis
Coronary Occlusion
Non-Invasive Medical Device
Cardiac Diagnostics
Lead sponsor: AusculSciences Canada Inc.
Sponsor class: INDUSTRY
Collaborators: name: Ottawa Heart Institute Research Corporation
name: Horizon Health Network
name: University of Calgary
name: Hamilton Health Sciences Corporation
First posted: 2019-04-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Primary outcomes:
measure: Number of Participants suspected of having Coronary Artery Disease
timeFrame: up to 1 Year
Secondary outcomes:
measure: Estimation of coronary artery stenosis by the CAD-det device.
timeFrame: up to 1 year
measure: Estimation of coronary artery stenosis by CCTA and ICA categorized by sex as:
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre (University of Calgary)
state: Alberta
city: Saint John
country: Canada
facility: Horizon Health Network, Saint John Regional Hospital
state: New Brunswick
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: University of Ottawa Heart Institute (UOHI)
name: Benjamin Chow, MD, FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.