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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

395 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-31

Study Completion Date

2022-05-31

Brief Summary

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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.

Detailed Description

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This is a prospective multi-center clinical trial. Using the CAD-det, acoustic and electrical cardiac data will be collected from participants with intermediate pretest probability of CAD who are referred to invasive coronary angiography (ICA). The CAD-det recording will be administered prior to the scheduled ICA procedure. The data collected by CAD-det will be processed using AusculSciences' Data Analysis Application (DAA) to produce a patient's indication for CAD.

Conditions

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Coronary Artery Disease Cardiovascular Diseases Atherosclerosis Coronary Occlusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

CAD-det
Primary Study Purpose

OTHER

Blinding Strategy

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Stable
2. \>/= 19 years old
3. Suspected obstructive CAD
4. Referred to ICA

Exclusion Criteria

1. Documented CAD or coronary revascularization
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
Minimum Eligible Age

19 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role collaborator

AusculSciences Canada Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Melissa Spero, CRN, CCRP

Role: CONTACT

613 763-0088 ext. 107

John Phillips, BSc.

Role: CONTACT

613 763-0088

Facility Contacts

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Farrah Ahmed

Role: primary

613-696-7000 ext. 12697

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.

Reference Type BACKGROUND
PMID: 23290309 (View on PubMed)

Related Links

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Other Identifiers

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CAD-det Validation

Identifier Type: -

Identifier Source: org_study_id

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