CCTA to Optimize Diagnostic Yield of Invasive Angiography With AI (CarDIA-AI)

May 8, 2026 updated by: Hamilton Health Sciences Corporation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
251

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jeremy Petch, PhD
  • Phone Number: 416-476-9039
  • Email: petchj@HHSC.CA

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University Medical Centre
      • St. Catharines, Ontario, Canada, L2S 0A9
        • St. Catharines Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Usual Care
Patients will proceed directly to ICA as originally referred.
Other: Usual Care
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.
Experimental: Centralized triage with risk score-based screening for obstructive CAD
Patients 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.
Other: Centralized triage with risk score-based screening for obstructive CAD
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of normal/non-obstructive CAD diagnosed through ICA
Time Frame: 90 days (after randomization)
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.
90 days (after randomization)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quantitative assessment of number of angiograms avoided
Time Frame: 90 days (after randomization)
Number of angiograms avoided due to CCTA bookings.
90 days (after randomization)
Deviation from management recommendations following CCTA (i.e. angiograms performed when not recommended)
Time Frame: 90 days (after randomization)
Number of angiograms performed when not recommended.
90 days (after randomization)
Diagnostic yield of invasive angiography
Time Frame: 90 days (after randomization)
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).
90 days (after randomization)
Sex differences in rate of normal/non-obstructive CAD diagnosed through ICA
Time Frame: 90 days (after randomization)
Difference in the rate of normal/non-obstructive CAD diagnosed through ICA between males and females.
90 days (after randomization)
Site differences in rate of normal/non-obstructive CAD diagnosed through ICA
Time Frame: 90 days (after randomization)
Difference in the rate of normal/non-obstructive CAD diagnosed through ICA between sites.
90 days (after randomization)
Budget impact of new strategy for risk stratification of CAD in low-risk patients
Time Frame: 90 days (after randomization)
Cost of risk stratification of CAD in low risk patients.
90 days (after randomization)
Number of low-quality CCTAs
Time Frame: 90 days (after randomization)
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.
90 days (after randomization)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hamilton Health Sciences Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Population Health Research Institute
Hamilton Academic Health Sciences Organization

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jon-David Schwalm, MD, MSc, Hamilton Health Sciences Corporation
  • Principal Investigator: Jeremy Petch, PhD, Hamilton Health Sciences Corporation
  • Principal Investigator: Natalia Pinilla-Echeverri, MD, PhD, Niagara Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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