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

NCT03914079 | Suspended DMC

• 1 other identifier: CAD-det-Research-Study
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 3

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).

Conditions

Coronary Artery Disease; Cardiovascular Disease

Keywords

Coronary Artery Disease; Cardiovascular Disease; Atherosclerosis; Coronary Occlusion; Non-Invasive Medical Device; Cardiac Diagnostics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Estimation of coronary artery stenosis by the CAD-det device.

  up to 1 year

• Estimation of coronary artery stenosis by CCTA and ICA categorized by sex as:

  up to 1 year

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Age ≥ 19 years;
• Suspected or known CAD;
• Able and willing to comply with the study procedures;
• Referred to ICA or CCTA for CAD characterization;
• Willingness and ability to sign the Informed Consent Form.

You may not qualify if:

• Unwillingness or inability to provide informed consent;
• Age less than 19 years;
• Pregnancy;
• Skin injury/diseases/lesions that would preclude safe application of the CAD-det device.

Sponsors & Collaborators

• AusculSciences Canada Inc.: lead
• Ottawa Heart Institute Research Corporation: collaborator
• Horizon Health Network: collaborator
• University of Calgary: collaborator
• Hamilton Health Sciences Corporation: collaborator

Study Sites (3)

Foothills Medical Centre (University of Calgary)

Calgary, Alberta, T2N 2T9, Canada

Location

Horizon Health Network, Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L5, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (1)

• 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.

  PMID: 23290309 BACKGROUND

Related Links

• Study Sponsor

MeSH Terms

Conditions

Coronary Artery Disease; Cardiovascular Diseases; Atherosclerosis; Coronary Occlusion

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Benjamin Chow, MD, FRCP(C)

  University of Ottawa Heart Institute (UOHI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: April 16, 2019
• Study Start: April 5, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)