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Clinical Trials/NCT06648239
NCT06648239
Active, not recruiting
Not Applicable

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

Hamilton Health Sciences Corporation3 sites in 1 country251 target enrollmentJanuary 9, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Hamilton Health Sciences Corporation
Enrollment
251
Locations
3
Primary Endpoint
Rate of normal/non-obstructive CAD diagnosed through ICA
Status
Active, not recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 9, 2025
End Date
February 1, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Quantitative assessment of number of angiograms avoided(90 days (after randomization))
  • Deviation from management recommendations following CCTA (i.e. angiograms performed when not recommended)(90 days (after randomization))
  • Diagnostic yield of invasive angiography(90 days (after randomization))
  • Sex differences in rate of normal/non-obstructive CAD diagnosed through ICA(90 days (after randomization))
  • Site differences in rate of normal/non-obstructive CAD diagnosed through ICA(90 days (after randomization))
  • Budget impact of new strategy for risk stratification of CAD in low-risk patients(90 days (after randomization))
  • Number of low-quality CCTAs(90 days (after randomization))

Study Sites (3)

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