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
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• Adult inpatients and outpatients who are scheduled for head CTA scanning.
Locations
Other Locations
China
The First Hospital of Jilin University
RECRUITING
Changchun
Guizhou Provincial People's Hospital
RECRUITING
Guiyang
Hainan General Hospital
RECRUITING
Haikou
The First Affiliated Hospital of University of Science and Technology of China
RECRUITING
Hefei
Shandong Provincial Hospital Affiliated to Shandong First Medical University
RECRUITING
Jinan
The First People's Hospital of Kashgar Region
RECRUITING
Kashgar
The First Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
University Second Hospital
RECRUITING
Lanzhou
First People's Hospital of Lianyungang
RECRUITING
Lianyungang
Ma'anshan People's Hospital
RECRUITING
Ma’anshan
BenQ Medical Center, Affiliated BenQ Hospital of Medical School, Nanjing Medical University
RECRUITING
Nanjing
Research Institute Of Medical Imaging Jinling Hospital
RECRUITING
Nanjing
Long Gang Central Hospital of Shenzhen
RECRUITING
Shenzhen
Shiyan People's Hospital
RECRUITING
Shiyan
The Affiliated Suqian First Hospital of Nanjing Medical University
RECRUITING
Suqian
Tianjin Medical University General Hospital
RECRUITING
Tianjin
Yidu Central Hospital Affiliated to Shandong Second Medical University
RECRUITING
Weifang
The First Affiliated Hospital of Wannan Medical College
RECRUITING
Wuhu
Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
General Hospital of Ningxia Medical University
RECRUITING
Yinchuan
First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Longjiang Zhang, MD
kevinzhlj@163.com
+8613405833176
Time Frame
Start Date: 2024-05-20
Estimated Completion Date: 2026-12
Participants
Target number of participants: 6450
Treatments
Experimental: True-AI-integrated intracranial aneurysms diagnosis strategy
For patients who underwent head CTA and assigned to True-AI group, they will be diagnosed by a radiologist who are aided by the True-AI-integrated intracranial aneurysms diagnosis strategy.
Sham_comparator: Sham-AI-integrated intracranial aneurysms diagnosis strategy
For patients who underwent head CTA and assigned to Sham-AI group, they will be diagnosed by a radiologist who are aided by the Sham-AI-integrated intracranial aneurysms diagnosis strategy. To mimic the True-AI, the Sham-AI had a sensitivity close to 0% and a similar specificity to the True-AI.
Related Therapeutic Areas
Sponsors
Leads: Jinling Hospital, China