A Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease The CAD-det Validation Study
Validation of the CAD-det System, a Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease (The CAD-det Validation Study)
1 other identifier
interventional
395
1 country
2
Brief Summary
The purpose of the study is to collect acoustic, ECG, and clinical data from consenting participants, so that AusculSciences can perform analysis on the sounds produced by the heart and determine the accuracy of the CAD-det System for detecting CAD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Mar 2021
Shorter than P25 for not_applicable coronary-artery-disease
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2020
CompletedFirst Posted
Study publicly available on registry
September 24, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedSeptember 24, 2020
September 1, 2020
1 year
September 18, 2020
September 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
CAD-det to validate:
CAD-det to detect obstructive CAD as defined as QCA diameter stenosis greater than or equal to 50%.
up to 1 Year
Secondary Outcomes (1)
CAD-det to detect:
up to 1 year
Interventions
CAD-det test will be done on participants with suspected CAD clinically referred for ICA at a participating clinical investigation site.
Eligibility Criteria
You may qualify if:
- Stable
- \>/= 19 years old
- Suspected obstructive CAD
- Referred to ICA
You may not qualify if:
- Documented CAD or coronary revascularization
- Age \< 19 years old
- Acute coronary syndromes
- Congenital heart disease or heart transplantation
- Dextrocardia
- Uncontrolled irregular heart rhythm (atrial arrhythmia (fibrillation, flutter) or frequent PACs or PVCs (\>10/minute))
- Resting heart rate \> 110 bpm
- Known hemodynamically-significant valvular heart disease, audible diastolic murmurs, or hypertrophic or non-ischemic cardiomyopathy
- Chest wall deformity or wounds in adhesive application areas
- Pregnancy
- Unwillingness or inability to provide informed consent or to comply with the study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
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: 23290309BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ben Chow, MD
Ottawa Heart Institue Research Foundation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2020
First Posted
September 24, 2020
Study Start
March 1, 2021
Primary Completion
March 1, 2022
Study Completion
May 1, 2022
Last Updated
September 24, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share