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Coronary Computed Tomographic Angiography to Optimize the Diagnostic Yield of Invasive Angiography for Low-Risk
Jeremy Petch1,2,3,4, Juan Pablo Tabja Bortesi3,5, Tej Sheth1,2
1Population Health Research Institute, Hamilton, ON, Canada.
Insights
The CarDIA-AI study uses artificial intelligence (AI) to guide patients toward the most appropriate cardiac imaging test, aiming to improve diagnostic efficiency and reduce risks associated with invasive coronary angiography (ICA). This approach may help avoid unnecessary procedures for patients with nonobstructive coronary artery disease (CAD).
Area of Science:
- Cardiology
- Medical Imaging
- Artificial Intelligence in Healthcare
Background:
- Invasive coronary angiography (ICA) is the standard for diagnosing coronary artery disease (CAD) but carries risks and is often used in patients without significant blockages.
- Coronary computed tomographic angiography (CCTA) offers a less invasive alternative for low-to-intermediate risk patients.
- Optimizing the selection between ICA and CCTA is crucial for improving patient outcomes and healthcare efficiency.
Purpose of the Study:
- To evaluate an AI-based decision support tool for triaging patients referred for nonurgent ICA.
- To determine if AI can optimize the use of ICA versus CCTA in outpatients.
- To improve the diagnostic yield and safety of cardiac investigations.
Main Methods:
- A pragmatic, open-label, randomized controlled trial involving 252 adults at two Canadian centers.
- Patients are randomized to usual care (direct ICA) or AI-guided triage (recommending CCTA or ICA).
- The AI tool predicts obstructive CAD probability using 42 clinical predictors from referral information and medical history.
Main Results:
- Recruitment started in January 2025, with 81 participants enrolled by April 14, 2025.
- The study is expected to conclude recruitment in late 2025, with results anticipated in 2026.
- Data analysis is pending completion of data collection.
Conclusions:
- CarDIA-AI is the first randomized trial to use AI for optimizing CCTA versus ICA selection.
- The study aims to enhance diagnostic efficiency and reduce complications from unnecessary ICA.
- Potential benefits include improved healthcare resource utilization and patient safety.
Background:
Invasive coronary angiography (ICA) is the gold standard in the diagnosis of coronary artery disease (CAD). Being invasive, it carries rare but serious risks including myocardial infarction, stroke, major bleeding, and death. A large proportion of elective outpatients undergoing ICA have nonobstructive CAD, highlighting the suboptimal use of this test. Coronary computed tomographic angiography (CCTA) is a noninvasive option that provides similar information with less risk and is recommended as a first-line test for patients with low-to-intermediate risk of CAD. Leveraging artificial intelligence (AI) to appropriately direct patients to ICA or CCTA based on the predicted probability of disease may improve the efficiency and safety of diagnostic pathways.
Objective:
he CarDIA-AI (Coronary computed tomographic angiography to optimize the Diagnostic yield of Invasive Angiography for low-risk patients screened with Artificial Intelligence) study aims to evaluate whether AI-based risk assessment for obstructive CAD implemented within a centralized triage process can optimize the use of ICA in outpatients referred for nonurgent ICA.
Methods:
CarDIA-AI is a pragmatic, open-label, superior randomized controlled trial involving 2 Canadian cardiac centers. A total of 252 adults referred for elective outpatient ICA will be randomized 1:1 to usual care (directly proceeding to ICA) or to triage using an AI-based decision support tool. The AI-based decision support tool was developed using referral information from over 37,000 patients and uses a light gradient boosting machine model to predict the probability of obstructive CAD based on 42 clinically relevant predictors, including patient referral information, demographic characteristics, risk factors, and medical history. Participants in the intervention arm will have their ICA referral forms and medical charts reviewed, and select details entered into the decision support tool, which recommends CCTA or ICA based on the patient's predicted probability of obstructive CAD. All patients will receive the selected imaging modality within 6 weeks of referral and will be subsequently followed for 90 days. The primary outcome is the proportion of normal or nonobstructive CAD diagnosed via ICA and will be assessed using a 2-sided z test to compare the patients referred for cardiac investigation with normal or nonobstructive CAD diagnosed through ICA between the intervention and control groups. Secondary outcomes include the number of angiograms avoided and the diagnostic yield of ICA.
Results:
Recruitment began on January 9, 2025, and is expected to conclude in mid to late 2025. As of April 14, 2025, we have enrolled 81 participants. Data analysis will begin once data collection is completed. We expect to submit the results for publication in 2026.
Conclusions:
CarDIA-AI will be the first randomized controlled trial using AI to optimize patient selection for CCTA versus ICA, potentially improving diagnostic efficiency, avoiding unnecessary complications of ICA, and improving health care resource usage.
Trial Registration:
ClinicalTrials.gov NCT06648239; https://clinicaltrials.gov/study/NCT06648239/.
International Registered Report Identifier (Irrid):
DERR1-10.2196/71726.
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