Clinical Trial

IDEAL Study: Blinded RCT for the Impact of AI Model for Cerebral Aneurysms Detection on Patients' Diagnosis and Outcomes

Study acronym: IDEAL
Recruiting
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Record status
This record was last updated October 7, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
This study (IEDAL study) intends to prospectively enroll more than 6450 patients who will undergo head CT angiography (CTA) scanning in the outpatient clinic. It will be carried out in 21 hospitals in more than 10 provinces in China. The patient's head CTA images will be randomly assigned to the True-AI and Sham-AI group with a ratio of 1:1, and the patients and radiologists are unaware of the allocation. The primary outcomes are sensitivity and specificity of detecting intracranial aneurysms. The secondary outcomes focus on the prognosis and outcomes of the patients.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-11-01; most recent amendment 2025-10-01.
Status change: Not Yet Recruiting → Recruiting 2025-08-04
Trial Details
NCT Number NCT06118840
Lead Sponsor Jinling Hospital, China
Conditions Intracranial Aneurysm, CT Angiography, Deep Learning, Double Bind Interaction
Enrollment 6,450 participants
Start Date 2024-05-20
Primary Completion 2026-07 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-10-07