A Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease The CAD-det Validation Study
NCT ID: NCT04562142
Last Updated: 2020-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
395 participants
INTERVENTIONAL
2021-03-31
2022-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Interventions
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CAD-det
CAD-det test will be done on participants with suspected CAD clinically referred for ICA at a participating clinical investigation site.
Eligibility Criteria
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Inclusion Criteria
2. \>/= 19 years old
3. Suspected obstructive CAD
4. Referred to ICA
Exclusion Criteria
2. Age \< 19 years old
3. Acute coronary syndromes
4. Congenital heart disease or heart transplantation
5. Dextrocardia
6. Uncontrolled irregular heart rhythm (atrial arrhythmia (fibrillation, flutter) or frequent PACs or PVCs (\>10/minute))
7. Resting heart rate \> 110 bpm
8. Known hemodynamically-significant valvular heart disease, audible diastolic murmurs, or hypertrophic or non-ischemic cardiomyopathy
9. Chest wall deformity or wounds in adhesive application areas
10. Pregnancy
11. Unwillingness or inability to provide informed consent or to comply with the study protocol
19 Years
100 Years
ALL
No
Sponsors
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Ottawa Heart Institute Research Corporation
OTHER
AusculSciences Canada Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ben Chow, MD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Heart Institue Research Foundation
Locations
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The University of Ottawa Heart Institute
Ottawa, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Related Links
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Study Sponsor
Other Identifiers
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CAD-det Validation
Identifier Type: -
Identifier Source: org_study_id
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