Coronary Computed Tomographic Angiography to Optimize the Diagnostic Yield of Invasive Angiography for Low-Risk Patients Screened With Artificial Intelligence: Protocol for the CarDIA-AI Randomized Controlled Trial (Preprint)
Bibliographic record
Abstract
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. CLINICALTRIAL ClinicalTrials.gov NCT06648239; https://clinicaltrials.gov/study/NCT06648239/ INTERNATIONAL REGISTERED REPORT DERR1-10.2196/71726
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.009 | 0.013 |
| Meta-epidemiology (narrow) | 0.004 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.004 | 0.004 |
| Insufficient payload (model declined to judge) | 0.043 | 0.006 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".