Coronary Artery DiseaseCAD-detNCT03914079
Evaluation of the CAD-det System, a Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease
An observational study of Coronary Artery Disease and Cardiovascular Disease, run by AusculSciences Canada Inc. at 3 sites in Canada.
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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Cardiovascular Disease
- How many people
- 2,000 participants
- Where
- 3 sitesCanada
- Study dates
- 5 Apr 2019to Dec 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 2,000 men and women age 19 and over with suspected or known CAD referred for clinically indicated Invasive Coronary Angiography (ICA) or Coronary Computed Tomography Angiography (CCTA).
Who may be able to join
- Age ≥ 19 years;
- Suspected or known CAD;
- Able and willing to comply with the study procedures;
- Referred to ICA or CCTA for CAD characterization;
- Willingness and ability to sign the Informed Consent Form.
Who cannot join
- Unwillingness or inability to provide informed consent;
- Age less than 19 years;
- Pregnancy;
- Skin injury/diseases/lesions that would preclude safe application of the CAD-det device.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Foothills Medical Centre (University of Calgary)
Calgary, Alberta, T2N 2T9
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Horizon Health Network, Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L5
About this study
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).
Read the detailed 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.
- Conditions
- Coronary Artery Disease, Cardiovascular Disease
- Keywords
- Coronary Artery Disease, Cardiovascular Disease, Atherosclerosis, Coronary Occlusion, Non-Invasive Medical Device, Cardiac Diagnostics
- Medical subject headings
- Coronary Artery Disease, Cardiovascular Diseases, Atherosclerosis, Coronary Occlusion
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 Year
Secondary outcomes (2)
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.
Measured: up to 1 year
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.
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 posted16 Apr 2019
- Study start5 Apr 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Sponsor due to COVID-19
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- AusculSciences Canada Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ottawa Heart Institute Research Corporation, Horizon Health Network, University of Calgary, Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Benjamin Chow, MD, FRCP(C), Principal investigator, University of Ottawa Heart Institute (UOHI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914079
- Sponsor's protocol ID
- CAD-det-Research-Study
- Acronym
- CAD-det
- Status last verified
- Jan 2021
- First submitted
- 31 Jan 2019
- Last updated
- 12 Jan 2021
- 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 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the CAD-det System, a Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03914079
- Acronym / sponsor ID
- CAD-det / CAD-det-Research-Study
- Conditions
- Coronary Artery Disease, Cardiovascular Disease
- Keywords
- Coronary Artery Disease, Cardiovascular Disease, Atherosclerosis, Coronary Occlusion, Non-Invasive Medical Device, Cardiac Diagnostics
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Sponsor due to COVID-19
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- AusculSciences Canada Inc.Industry (pharma, biotech, devices)
- Collaborators
- Ottawa Heart Institute Research Corporation, Horizon Health Network, University of Calgary, Hamilton Health Sciences Corporation
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Apr 2019 (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 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).
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 2,000 men and women age 19 and over with suspected or known CAD referred for clinically indicated Invasive Coronary Angiography (ICA) or Coronary Computed Tomography Angiography (CCTA).
Key inclusion criteria (5 listed)
- Age ≥ 19 years;
- Suspected or known CAD;
- Able and willing to comply with the study procedures;
- Referred to ICA or CCTA for CAD characterization;
- Willingness and ability to sign the Informed Consent Form.
Key exclusion criteria (4 listed)
- Unwillingness or inability to provide informed consent;
- Age less than 19 years;
- Pregnancy;
- Skin injury/diseases/lesions that would preclude safe application of the CAD-det device.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants suspected of having Coronary Artery Disease
Time frame: up to 1 Year
Collection of all acoustic cardiac data to allow for the acoustic discrimination of the presence and degree of CAD in diseased and healthy participants.
2 secondary outcomes
Estimation of coronary artery stenosis by the CAD-det device.
Time frame: up to 1 year
Estimation of coronary artery stenosis by CCTA and ICA categorized by sex as:
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 12 Jan 2021.
- 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.
Benjamin Chow, MD, FRCP(C) principal investigator
University of Ottawa Heart Institute (UOHI)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Cardiovascular Disease, run by AusculSciences Canada Inc. at 3 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 5 inclusion and 4 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: paused, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants suspected of having Coronary Artery Disease (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 NCT03914079, 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 12 Jan 2021.