NCT06648239Completed
CCTA to Optimize Diagnostic Yield of Invasive Angiography With AI
Coronary Computed Tomographic Angiography to Optimize Diagnostic Yield of Invasive Angiography for Low-risk Patients Screened With Artificial Intelligence
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 251 (actual)
- First submitted
- 16 Oct 2024
- Start date
- 9 Jan 2025
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- Hamilton Health Sciences Corporation
- Diseases
- Coronary artery disease
- NCT number
- NCT06648239
What you commit to
- Study type: Interventional
- Participants enrolled: 251
- From 9 Jan 2025 to the primary completion date, 1 Jan 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McMaster University Medical Centre Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Hamilton General Hospital Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| St. Catharines Hospital Coordinator of this site? Confirm its status | St. Catharines | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.