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Coronary Artery DiseaseCarDIA-AINCT06648239

CCTA to Optimize Diagnostic Yield of Invasive Angiography With AI

A study testing Centralized triage with risk score-based screening for obstructive CAD in people with Coronary Artery Disease, run by Hamilton Health Sciences Corporation at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Coronary artery disease (CAD) is a leading cause of death. The gold-standard test used to diagnose CAD is invasive coronary angiography (ICA). However, nearly half the patients who receive ICA are found to have no disease or non-significant disease. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Coronary Artery Disease
What is being tested?
Centralized triage with risk score-based screening for obstructive CAD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
251 participants
Where
3 sitesCanada
Study dates
9 Jan 2025to 1 Jan 2026
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Patients are eligible to participate if they: 1) are ≥18 years of age; 2) are referred for non-urgent (elective) outpatient ICA; 3) have an indication for ICA that includes 'Rule out CAD', 'Cardiomyopathy', or 'Stable CAD'; and 4) are able to provide informed consent in English. Patients fulfilling any of the following criteria will be ineligible to participate: 1) prior high-quality coronary computed tomographic angiography (CCTA) within the last 5 years; 2) atrial fibrillation; 3) known severe renal dysfunction (GFR <35); 4) planned non-coronary cardiac surgery; 5) any prior obstructive CAD, acute coronary syndrome, percutaneous coronary intervention, or coronary artery bypass graft; 6) known severe coronary artery calcification (calcium score >250); or have a body mass index (BMI) exceeding 40.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

  • McMaster University Medical Centre

    Hamilton, Ontario, L8N 3Z5

  • St. Catharines Hospital

    St. Catharines, Ontario, L2S 0A9

Other trials in Canada

About this study

Official title: Coronary Computed Tomographic Angiography to Optimize Diagnostic Yield of Invasive Angiography for Low-risk Patients Screened With Artificial Intelligence

Coronary artery disease (CAD) is a leading cause of death. The gold-standard test used to diagnose CAD is invasive coronary angiography (ICA). However, nearly half the patients who receive ICA are found to have no disease or non-significant disease. This means that while they receive a diagnosis, they do not receive any therapeutic benefit. This is concerning because ICA is expensive and it carries a risk to patients. A non-invasive diagnostic test, cardiac computed tomographic angiography (CCTA), has been shown to be as effective as ICA at diagnosing CAD in the right patient population, while being less expensive and less risky for patients. An optimal solution would involve screening to identify which patients are good candidates for CCTA vs. which should receive ICA. This screening tool could be used in a triage pathway to ensure that every patient gets the test that is best for them. The investigators have used Artificial Intelligence (AI) to develop a model for determining which patients should receive ICA vs. which should receive CCTA. The investigators have also developed a triage pathway to direct patients to the most appropriate test. The investigators now plan to evaluate the AI tool combined with the triage pathway through a clinical trial at Hamilton Health Sciences and Niagara Health. This model of care will reduce risk to patients, reduce wait times for ICA and reduce costs to the health care system.

Being tested
Usual Care, Centralized triage with risk score-based screening for obstructive CAD
Keywords
Artificial Intelligence (AI), Coronary Angiography, Coronary Computed Tomography Angiography
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Usual CareOther

    In the usual care group, patients will proceed directly to ICA following referral from community cardiology, as is the current standard of care. Research staff will screen participants in this group for significant CAD using the decision support tool; however, the tool's recommendations will not affect their care, as all patients in this group will invariably receive ICA.

  • Centralized triage with risk score-based screening for obstructive CADOther

    Patients randomized to the intervention will have selected features of their medical history, recorded on their referral form, entered into a decision support tool by research personnel to generate a recommendation of whether they should proceed directly to ICA or whether they should receive CCTA. Patients with recommendations for ICA will proceed directly to ICA. Patients with recommendations for CCTA will be referred to CCTA. Based on the results of the CCTA, recommendations for medical management versus referral for ICA will be made.

Study groups in NCT06648239
Study groupRoleWhat they receive
Usual CareActive comparatorPatients will proceed directly to ICA as originally referred.
Receives: Other: Usual Care
Centralized triage with risk score-based screening for obstructive CADExperimentalPatients originally referred for ICA will be screened for obstructive CAD with a decision support tool that uses data from their referral forms. Patients will receive either CCTA or ICA based on their predicted probability of obstructive CAD.
Receives: Other: Centralized triage with risk score-based screening for obstructive CAD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of normal/non-obstructive CAD diagnosed through ICA

    The rate of normal or non-obstructive CAD diagnosed through ICA in patients referred for cardiac investigation. The rate for an arm (control vs experimental) is calculated by dividing the number of patients diagnosed with normal/non-obstructive CAD through ICA by the total patients allocated to the arm.

    Measured: 90 days (after randomization)

Secondary outcomes (7)

  1. Quantitative assessment of number of angiograms avoided

    Number of angiograms avoided due to CCTA bookings.

    Measured: 90 days (after randomization)

  2. Deviation from management recommendations following CCTA (i.e. angiograms performed when not recommended)

    Number of angiograms performed when not recommended.

    Measured: 90 days (after randomization)

  3. Diagnostic yield of invasive angiography

    Diagnostic yield is defined as the proportion of invasive angiograms that identify significant disease (≥70% stenosis) on a major coronary vessel (>2 mm) or >50% stenosis in the left main).

    Measured: 90 days (after randomization)

  4. Sex differences in rate of normal/non-obstructive CAD diagnosed through ICA

    Difference in the rate of normal/non-obstructive CAD diagnosed through ICA between males and females.

    Measured: 90 days (after randomization)

  5. Site differences in rate of normal/non-obstructive CAD diagnosed through ICA

    Difference in the rate of normal/non-obstructive CAD diagnosed through ICA between sites.

    Measured: 90 days (after randomization)

  6. Budget impact of new strategy for risk stratification of CAD in low-risk patients

    Cost of risk stratification of CAD in low risk patients.

    Measured: 90 days (after randomization)

  7. Number of low-quality CCTAs

    The quality will be graded on a per-patient basis using a three-class system: low quality, denoting an image in which the coronary anatomy cannot be clearly defined, requiring ICA within 90 days for clarification; suboptimal quality, denoting an image in which the coronary anatomy was equivocal for one or more non-prognostic vessels but not requiring ICA based on CCTA findings and clinical presentation; and high quality, denoting an image in which the coronary anatomy could be clearly defined.

    Measured: 90 days (after randomization)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2024
  2. Study start9 Jan 2025
  3. Primary completion1 Jan 2026
  4. Study completion1 Jan 2026

Resources

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
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
251 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06648239
Sponsor's protocol ID
17103
Acronym
CarDIA-AI
Status last verified
Apr 2026
First submitted
16 Oct 2024
Last updated
11 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schwalm JD, Di S, Sheth T, Natarajan MK, O'Brien E, McCready T, Petch J. A machine learning-based clinical decision support algorithm for reducing unnecessary coronary angiograms. Cardiovasc Digit Health J. 2021 Dec 24;3(1):21-30. doi: 10.1016/j.cvdhj.2021.12.001. eCollection 2022 Feb.

    PubMed 35265932

  • Schwalm JD, Bouck Z, Natarajan MK, Pinilla N, Walker D, Syed N, Landry D, Sabri A, Tandon V, Nkurunziza J, Taljaard M, Sheth T. Centralized Triage of Suspected Coronary Artery Disease Using Coronary Computed Tomographic Angiography to Optimize the Diagnostic Yield of Invasive Angiography. CJC Open. 2022 Nov 19;5(2):148-157. doi: 10.1016/j.cjco.2022.10.009. eCollection 2023 Feb.

    PubMed 36880068

  • Schwalm JD, Sheth T, Pinilla-Echeverri N, Petch J. Using Artificial Intelligence to Optimize the Use of Cardiac Investigations in Patients With Suspected Coronary Artery Disease. J Soc Cardiovasc Angiogr Interv. 2024 Mar 26;3(3Part B):101305. doi: 10.1016/j.jscai.2024.101305. eCollection 2024 Mar. No abstract available.

    PubMed 39131228

  • Petch J, Tabja Bortesi JP, Sheth T, Natarajan M, Pinilla-Echeverri N, Di S, Bangdiwala SI, Mosleh K, Ibrahim O, Bainey KR, Dobranowski J, Becerra MP, Sonier K, Schwalm JD. Coronary Computed Tomographic Angiography to Optimize the Diagnostic Yield of Invasive Angiography for Low-Risk Patients Screened With Artificial Intelligence: Protocol for the CarDIA-AI Randomized Controlled Trial. JMIR Res Protoc. 2025 May 21;14:e71726. doi: 10.2196/71726.

    PubMed 40397500

Questions about this trial

What is this clinical trial studying?

A study testing Centralized triage with risk score-based screening for obstructive CAD in people with Coronary Artery Disease, run by Hamilton Health Sciences Corporation 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?

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: finished, as of the sponsor's last update on 11 May 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Rate of normal/non-obstructive CAD diagnosed through ICA (time frame: 90 days (after randomization)). 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 NCT06648239, which also lists 4 linked publications.

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 11 May 2026.

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