CCTA to Optimize Diagnostic Yield of Invasive Angiography With AI (CarDIA-AI)

Hamilton Health Sciences (HHS)

Status: Active, not recruiting

Conditions: Coronary Artery Disease

Treatments: Other: Centralized triage with risk score-based screening for obstructive CAD; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06648239

17103

Details and patient eligibility

About

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.

Enrollment: 251 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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251 participants in 2 patient groups

Usual Care

Active Comparator group

Description:

Patients will proceed directly to ICA as originally referred.

Treatment:

Other: Usual Care

Centralized triage with risk score-based screening for obstructive CAD

Experimental group

Description:

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.

Treatment:

Other: Centralized triage with risk score-based screening for obstructive CAD