NCT06648239

CCTA to Optimize Diagnostic Yield of Invasive Angiography With AI

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2025-01-09
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2024-10-18
• Last updated: 2025-12-12

Locations

3 sites across 1 country: Canada