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IDEAL Study: Blinded RCT for the Impact of AI Model for Cerebral Aneurysms Detection on Patients' Diagnosis and Outcomes
Sponsor: Jinling Hospital, China
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.
Official title: Assessing the Impact of an Artificial Intelligence-Based Model for Intracranial Aneurysm Detection in CT Angiography on Patients' Diagnosis and Outcomes: The IDEAL Study - A Web-Based Multicenter, Double-Blinded Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
6450
Start Date
2024-05-20
Completion Date
2026-12
Last Updated
2025-10-07
Healthy Volunteers
Yes
Interventions
True-AI-integrated intracranial aneurysms diagnosis strategy
The True-AI deep-learning based model for intracranial aneurysms detection had a patient-wise sensitivity, lesion-wise sensitivity and specificity of 0.96, 0.87, and 0.80 in the internal validation dataset.
Sham-AI-integrated intracranial aneurysms diagnosis strategy
The Sham-AI deep-learning based model for intracranial aneurysms detection is designed to have a sensitivity close to 0% and a similar specificity to the True-AI. In the internal validation dataset, the Sham-AI had a patient-wise sensitivity, lesion-wise sensitivity, specificity of 0.02, 0.01, and 0.80, respectively.
Locations (21)
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Shiyan People's Hospital
Shiyan, Hubei, China
Research Institute Of Medical Imaging Jinling Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Yidu Central Hospital Affiliated to Shandong Second Medical University
Weifang, Shandong, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Hainan General Hospital
Haikou, China
The First People's Hospital of Kashgar Region
Kashgar, China
University Second Hospital
Lanzhou, China
First People's Hospital of Lianyungang
Lianyungang, China
Ma'anshan People's Hospital
Ma’anshan, China
BenQ Medical Center, Affiliated BenQ Hospital of Medical School, Nanjing Medical University
Nanjing, China
Long Gang Central Hospital of Shenzhen
Shenzhen, China
The Affiliated Suqian First Hospital of Nanjing Medical University
Suqian, China
Tianjin Medical University General Hospital
Tianjin, China
General Hospital of Ningxia Medical University
Yinchuan, China