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Stepped-Wedge Cluster Randomized Trial of AI-Assisted CTA Detection for Intracranial Aneurysms in Regional Hospitals
Sponsor: Jinling Hospital, China
Summary
This study (IDEAL 2) is a nationwide stepped-wedge cluster-randomized trial designed to prospectively enroll over 14,400 patients undergoing outpatient head CT angiography (CTA). The trial will be conducted across more than 72 regional hospitals in China. Clusters were randomly assigned to nine randomization groups. In accordance with the stepped-wedge design, clusters will sequentially transition from the control condition (standard human diagnosis) to the intervention condition (AI-assisted diagnosis) at regular intervals over a 10-month period, until all clusters receive the intervention. The primary outcome is the detection rate of intracranial aneurysms. Secondary outcomes include patient prognosis and clinical outcomes.
Official title: Impact of an AI-Driven CT Angiography Model on Intracranial Aneurysm Detection and Clinical Outcomes in Regional Hospitals (IDEAL2): A Nationwide Stepped-Wedge Cluster-Randomized Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
14400
Start Date
2025-10-09
Completion Date
2029-08-31
Last Updated
2025-08-20
Healthy Volunteers
Yes
Interventions
AI-Assisted CTA Interpretation
A locked, independently validated deep learning model was used to assist radiologists in interpreting head CTA scans. The model was trained on 16,546 CTA cases and externally validated on an independent set of 900 DSA-verified CTA cases, achieving a patient-level sensitivity of 0.943 and an average of 0.187 false positives per case.
Standard CTA Interpretation
Head CTA interpretation performed by radiologists using local routine diagnostic workflows without AI support.