Coronary Computed Tomographic Angiography to Optimize Diagnostic Yield of Invasive Angiography for Low-risk Patients Screened With Artificial Intelligence
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 251
- Locations
- 6
- Primary Endpoint
- Rate of normal/non-obstructive CAD diagnosed through ICA
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •Patients are ineligible if they have:
- •received a prior high-quality coronary computed tomographic angiography (CCTA) within the last 5 years;
- •atrial fibrillation;
- •known severe renal dysfunction (GFR <35);
- •planned non-coronary cardiac surgery;
- •any prior obstructive CAD, acute coronary syndrome, percutaneous coronary intervention, or coronary artery bypass graft; or
- •known severe coronary artery calcification (calcium score >1000).
Arms & Interventions
Usual Care
Patients will proceed directly to ICA as originally referred.
Intervention: Usual Care (Other)
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.
Intervention: Centralized triage with risk score-based screening for obstructive CAD (Other)
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))