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

NARecruitingINTERVENTIONAL
Enrollment

6,450

Participants

Timeline

Start Date

May 20, 2024

Primary Completion Date

July 31, 2026

Study Completion Date

December 31, 2026

Conditions
Intracranial AneurysmCT AngiographyDeep LearningDouble Bind Interaction
Interventions
DEVICE

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.

DEVICE

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.

Trial Locations (21)

210018

RECRUITING

Research Institute Of Medical Imaging Jinling Hospital, Nanjing

Unknown

RECRUITING

The First Affiliated Hospital of University of Science and Technology of China, Hefei

RECRUITING

The First Affiliated Hospital of Wannan Medical College, Wuhu

RECRUITING

Guizhou Provincial People's Hospital, Guiyang

RECRUITING

First Affiliated Hospital of Zhengzhou University, Zhengzhou

RECRUITING

Shiyan People's Hospital, Shiyan

RECRUITING

Affiliated Hospital of Xuzhou Medical University, Xuzhou

RECRUITING

The First Hospital of Jilin University, Changchun

RECRUITING

Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan

RECRUITING

Yidu Central Hospital Affiliated to Shandong Second Medical University, Weifang

RECRUITING

The First Affiliated Hospital of Kunming Medical University, Kunming

RECRUITING

Hainan General Hospital, Haikou

RECRUITING

The First People's Hospital of Kashgar Region, Kashgar

RECRUITING

University Second Hospital, Lanzhou

RECRUITING

First People's Hospital of Lianyungang, Lianyungang

RECRUITING

Ma'anshan People's Hospital, Ma’anshan

RECRUITING

BenQ Medical Center, Affiliated BenQ Hospital of Medical School, Nanjing Medical University, Nanjing

RECRUITING

Long Gang Central Hospital of Shenzhen, Shenzhen

RECRUITING

The Affiliated Suqian First Hospital of Nanjing Medical University, Suqian

RECRUITING

Tianjin Medical University General Hospital, Tianjin

RECRUITING

General Hospital of Ningxia Medical University, Yinchuan

All Listed Sponsors
lead

Jinling Hospital, China

OTHER