CCTA to Optimize Diagnostic Yield of Invasive Angiography With AI

Last updated: January 28, 2025
Sponsor: Hamilton Health Sciences Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cardiac Disease

Chest Pain

Hypercholesterolemia

Treatment

Usual Care

Centralized triage with risk score-based screening for obstructive CAD

Clinical Study ID

NCT06648239
17103
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria

Patients are eligible 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.

Exclusion Criteria Patients are ineligible if they have:

  1. received a 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; or

  6. known severe coronary artery calcification (calcium score >1000).

Study Design

Total Participants: 252
Treatment Group(s): 2
Primary Treatment: Usual Care
Phase:
Study Start date:
January 09, 2025
Estimated Completion Date:
April 30, 2026

Connect with a study center

  • Hamilton General Hospital

    Hamilton, Ontario L8L 2X2
    Canada

    Active - Recruiting

  • McMaster University Medical Centre

    Hamilton, Ontario L8N 3Z5
    Canada

    Site Not Available

  • St. Catharines Hospital

    St. Catharines, Ontario L2S 0A9
    Canada

    Site Not Available

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