Coronary Artery DiseaseNCT04562142
A Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease The CAD-det Validation Study
A study testing CAD-det in people with Coronary Artery Disease and Cardiovascular Diseases, run by AusculSciences Canada Inc. at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Coronary Artery Disease, Cardiovascular Diseases, Atherosclerosis
- What is being tested?
- CAD-det
- Type of treatment
- Medical device
- How many people
- 395 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2021to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable
- >/= 19 years old
- Suspected obstructive CAD
- Referred to ICA
Who cannot join
- 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))
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- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Farrah Ahmed, 613-696-7000 ext. 12697, fahmed@ottawaheart.ca
Benjamin Chow, MD
About this study
Official title: Validation of the CAD-det System, a Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease (The CAD-det Validation Study)
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.
Read the detailed description
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.
- Being tested
- CAD-det
- Medical subject headings
- Coronary Artery Disease, Cardiovascular Diseases, Atherosclerosis, Coronary Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD-detDevice
CAD-det test will be done on participants with suspected CAD clinically referred for ICA at a participating clinical investigation site.
What is being measured
The primary outcome is the main question the study is designed to answer.
CAD-det to validate:
CAD-det to detect obstructive CAD as defined as QCA diameter stenosis greater than or equal to 50%.
Measured: up to 1 Year
Secondary outcomes (1)
CAD-det to detect:
- Obstructive CAD as defined as QCA diameter stenosis greater than or equal to 50% stratified according to sex (men and women).
- Severity of CAD by QCA:
- 0 - 25% diameter stenosis (Negative for obstructive CAD);
- 25 - 50% diameter stenosis (Negative for obstructive CAD);
- 50 - 69% diameter stenosis (Positive for obstructive CAD);
- 70% or greater diameter stenosis (Positive for obstructive CAD); and
- Equivocal or non-diagnostic.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study startMar 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- CAD-det
- Masking
- None (open label)
- Enrolment
- 395 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AusculSciences Canada Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ottawa Heart Institute Research Corporation
- Responsible party
- Sponsor
- Investigators
- Ben Chow, MD, Principal investigator, Ottawa Heart Institue Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562142
- Sponsor's protocol ID
- CAD-det Validation
- Status last verified
- Sep 2020
- First submitted
- 18 Sep 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23290309
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the CAD-det System, a Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease (The CAD-det Validation Study)
- ClinicalTrials.gov ID
- NCT04562142
- Acronym / sponsor ID
- CAD-det Validation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 395 participants (estimated)
- Lead sponsor
- AusculSciences Canada Inc.Industry (pharma, biotech, devices)
- Collaborators
- Ottawa Heart Institute Research Corporation
- Study start
- Mar 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- CAD-det
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stable
- >/= 19 years old
- Suspected obstructive CAD
- Referred to ICA
Key exclusion criteria (11 listed)
- Documented CAD or coronary revascularization
- Age < 19 years old
- Acute coronary syndromes
- Congenital heart disease or heart transplantation
- Dextrocardia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAD-detCAD-det test will be done on participants with suspected CAD clinically referred for ICA at a participating clinical investigation site. | Device | – |
Primary outcome
CAD-det to validate:
Time frame: up to 1 Year
CAD-det to detect obstructive CAD as defined as QCA diameter stenosis greater than or equal to 50%.
1 secondary outcome
CAD-det to detect:
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Background: PubMed 23290309Makaryus 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.
- Study SponsorLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Chow, MD principal investigator
Ottawa Heart Institue Research Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAD-det in people with Coronary Artery Disease and Cardiovascular Diseases, run by AusculSciences Canada Inc. at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melissa Spero, CRN, CCRP (613 763-0088 ext. 107, melissa@ausculsciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAD-det to validate: (time frame: up to 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04562142, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020.