CCTA to Optimize Diagnostic Yield of Invasive Angiography With AI

N/AActive Not RecruitingNCT06648239

Hamilton Health Sciences Corporation251 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

251

Conditions

Coronary Artery Disease

Interventions

Usual CareOTHER

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.

Centralized triage with risk score-based screening for obstructive CADOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Rate of normal/non-obstructive CAD diagnosed through ICA

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.