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Stepped-Wedge Cluster Randomized Trial of AI-Assisted CTA Detection for Intracranial Aneurysms in Regional Hospitals

NCT07124624 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14400

Last updated 2025-08-20

No results posted yet for this study

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.

Conditions

  • Intracranial Aneurysm
  • CT Angiography
  • AI (Artificial Intelligence)
  • Cluster Randomized Trial

Interventions

DEVICE

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.

DIAGNOSTIC_TEST

Standard CTA Interpretation

Head CTA interpretation performed by radiologists using local routine diagnostic workflows without AI support.

Sponsors & Collaborators

  • Jinling Hospital, China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-09
Primary Completion
2026-08-31
Completion
2029-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07124624 on ClinicalTrials.gov