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Centralized triage with risk score-based screening for obstructive CAD for Coronary Artery Disease (CarDIA-AI Trial)

N/A
Waitlist Available
Led By Jon-David Schwalm, MD, MSc
Research Sponsored by Hamilton Health Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. are ≥18 years of age;
2. are referred for non-urgent (elective) outpatient ICA;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days (after randomization)
Awards & highlights
No Placebo-Only Group

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days (after randomization)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days (after randomization) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of normal/non-obstructive CAD diagnosed through ICA
Secondary study objectives
Budget impact of new strategy for risk stratification of CAD in low-risk patients
Deviation from management recommendations following CCTA (i.e. angiograms performed when not recommended)
Diagnostic yield of invasive angiography
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Centralized triage with risk score-based screening for obstructive CADExperimental Treatment1 Intervention
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.
Group II: Usual CareActive Control1 Intervention
Patients will proceed directly to ICA as originally referred.

Find a Location

Who is running the clinical trial?

Hamilton Academic Health Sciences OrganizationOTHER
21 Previous Clinical Trials
4,823 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
186 Patients Enrolled for Coronary Artery Disease
Hamilton Health Sciences CorporationLead Sponsor
376 Previous Clinical Trials
340,116 Total Patients Enrolled
10 Trials studying Coronary Artery Disease
5,786 Patients Enrolled for Coronary Artery Disease
Population Health Research InstituteOTHER
163 Previous Clinical Trials
713,462 Total Patients Enrolled
7 Trials studying Coronary Artery Disease
15,363 Patients Enrolled for Coronary Artery Disease
~168 spots leftby Apr 2026