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

Coronary Artery Disease Clinical Trial

— CAD-det  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03914079
• Other study ID #: CAD-det-Research-Study
• Status: Suspended
• Start date: April 5, 2019
• Est. completion date: December 2022

Study information

• Verified date: January 2021
• Source: AusculSciences Canada Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 2000
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Canada	Foothills Medical Centre (University of Calgary)	Calgary	Alberta
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Horizon Health Network, Saint John Regional Hospital	Saint John	New Brunswick

Sponsors (5)

Lead Sponsor	Collaborator
AusculSciences Canada Inc.	Hamilton Health Sciences Corporation, Horizon Health Network, Ottawa Heart Institute Research Corporation, University of Calgary

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   Study Sponsor