CCTA to Optimize Diagnostic Yield of Invasive Angiography With AI

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT06648239
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-16
• Study First Submitted QC: 2024-10-17
• Study First Posted: 2024-10-18
• Status Verified: 2025-01
• Study Start: 2025-01-09
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of normal/non-obstructive CAD diagnosed through ICA	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.

Secondary Outcome Measures

Name	Time	Method
Quantitative assessment of number of angiograms avoided	90 days (after randomization)	Number of angiograms avoided due to CCTA bookings.
Deviation from management recommendations following CCTA (i.e. angiograms performed when not recommended)	90 days (after randomization)	Number of angiograms performed when not recommended.
Diagnostic yield of invasive angiography	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).
Sex differences in rate of normal/non-obstructive CAD diagnosed through ICA	90 days (after randomization)	Difference in the rate of normal/non-obstructive CAD diagnosed through ICA between males and females.
Site differences in rate of normal/non-obstructive CAD diagnosed through ICA	90 days (after randomization)	Difference in the rate of normal/non-obstructive CAD diagnosed through ICA between sites.
Budget impact of new strategy for risk stratification of CAD in low-risk patients	90 days (after randomization)	Cost of risk stratification of CAD in low risk patients.
Number of low-quality CCTAs	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.

Trial Locations

Locations (3)

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada

McMaster University Medical Centre; 🇨🇦 Hamilton, Ontario, Canada

St. Catharines Hospital; 🇨🇦 St. Catharines, Ontario, Canada