Evaluation of the Impact of AI-Based Cardiac CT Interpretation Tool on Emergency Physicians' Decision-Making
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 530
- 试验地点
- 1
- 主要终点
- NPV of EM physician CCTA interpretation (AI vs No AI)
研究概览
简要总结
" This prospective, pragmatic, randomized controlled trial is designed to evaluate the impact of an artificial intelligence (AI)-based coronary computed tomography angiography (CCTA) interpretation tool (Angiomics) on emergency physicians' diagnostic performance and clinical decision-making in patients presenting with acute chest pain.
CCTA is a critical diagnostic modality for suspected acute coronary syndrome (ACS) in the emergency department (ED). Accurate interpretation often requires experienced radiologists, who may not always be available, particularly during off-hours. The introduction of AI-based interpretation tools into clinical workflow has the potential to enhance diagnostic accuracy, increase physician confidence, reduce delays in decision-making, and improve efficiency of resource utilization. However, evidence regarding the real-world effectiveness of such AI tools in the ED setting remains limited.
Eligible participants will include adults aged 18 years or older presenting to the ED with chest pain and classified as intermediate risk (HEART score 4-6). Participants will be randomized into two groups: (1) AI-assisted CCTA interpretation, in which emergency physicians interpret scans with access to AI results; and (2) standard interpretation, in which emergency physicians interpret CCTA without AI support. In both groups, physicians will document the presence of stenosis in the four major coronary arteries (LM, LAD, LCX, RCA) and report diagnostic confidence on a 5-point Likert scale.
The primary outcome is the negative predictive value (NPV) of CCTA interpretation at the patient level, comparing AI-assisted versus standard interpretations against the reference standard of blinded consensus readings by board-certified radiologists. Secondary outcomes include sensitivity, specificity, positive predictive value (PPV), accuracy, diagnostic confidence, vessel-level diagnostic performance, and agreement with radiologist consensus using Cohen's Kappa.
The study aims to enroll approximately 530 participants (276 in the control arm and 254 in the intervention arm, accounting for an expected 10% dropout). Enrollment and follow-up will be conducted at Severance Hospital and Gangnam Severance Hospital over a 24-month period following IRB approval. The results are expected to provide evidence for the clinical utility and effectiveness of AI-based CCTA interpretation in the ED and to guide integration of AI into emergency care in order to optimize patient outcomes and healthcare efficiency.
详细描述
"This study is a prospective, pragmatic, randomized controlled trial designed to evaluate the impact of an artificial intelligence (AI)-based coronary computed tomography angiography (CCTA) interpretation tool (Angiomics) on the diagnostic accuracy, confidence, and decision-making of emergency physicians in patients presenting with acute chest pain.
Background and Rationale CCTA is widely used in the emergency department (ED) for patients presenting with acute chest pain or suspected acute coronary syndrome (ACS). It provides rapid and precise visualization of the coronary arteries and assists emergency physicians in making time-sensitive clinical decisions. However, interpretation of CCTA requires specialized training and experience, which may not always be available, particularly during nights or in resource-limited settings. This limitation can delay diagnosis and treatment, potentially leading to adverse patient outcomes.
Recent advances in AI technology have enabled the development of automated tools capable of analyzing CCTA images and identifying clinically significant findings such as coronary artery stenosis and myocardial ischemia. These tools have the potential to support emergency physicians by improving diagnostic accuracy, reducing interpretation time, enhancing physician confidence, and optimizing the use of healthcare resources. Despite these advantages, the influence of AI-based interpretation on real-world ED clinical workflows and physician decision-making remains insufficiently studied.
The present trial is designed to address this knowledge gap by evaluating whether the integration of an AI-based CCTA interpretation tool improves emergency physician diagnostic performance and clinical confidence, and whether such improvements translate into more reliable decision-making in the ED.
Study Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Patients presenting to the emergency department with chest pain
- •Patients assessed as intermediate risk (Heart Score 4-6)
排除标准
- •Prior history of coronary revascularization (coronary artery bypass graft surgery or stent placement)
- •Presence of intracardiac metallic devices such as pacemaker or prosthetic heart valves
- •Contraindications to contrast media (e.g., contrast allergy, severe renal impairment with eGFR < 30 mL/min/1.73 m²)
- •Patients unable to cooperate (e.g., severe anxiety, non-cooperation)
研究组 & 干预措施
AI-assisted CCTA interpretation
Emergency physicians interpret coronary CT angiography (CCTA) with the assistance of an AI-based interpretation tool (Angiomics). Physicians record stenosis presence in four major coronary vessels and rate diagnostic confidence using a 5-point Likert scale.
干预措施: Angiomics AI-based Coronary CT Interpretation Tool (Device)
Standard CCTA interpretation (without AI)
Emergency physicians independently interpret coronary CT angiography (CCTA) without access to the AI-based interpretation tool. Physicians record stenosis presence in four major coronary vessels and rate diagnostic confidence using a 5-point Likert scale.
干预措施: Standard CCTA Interpretation without AI (Other)
结局指标
主要结局
NPV of EM physician CCTA interpretation (AI vs No AI)
时间窗: During initial ED visit, at the time of CCTA interpretation
The proportion of patients with negative CCTA findings as interpreted by emergency physicians that are confirmed as true negatives by the reference standard (blinded consensus reading by board-certified radiologists). The analysis will compare the NPV of AI-assisted interpretation versus standard interpretation without AI. Patient-level outcomes will be derived by aggregating findings across the four major coronary arteries (LM, LAD, LCX, RCA)
次要结局
未报告次要终点