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IDEAL Study: Blinded RCT for the Impact of AI Model for Cerebral Aneurysms Detection on Patients' Diagnosis and Outcomes
Led by Jinling Hospital, China · Updated on 2025-10-07
6450
Participants Needed
21
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
IDEAL Study: Blinded RCT for the Impact of AI Model for Cerebral Aneurysms Detection on Patients' Diagnosis and Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults scheduled for head CT angiography (CTA) scanning as inpatients or outpatients
You will not qualify if you...
- Under 18 years of age
- Contraindications to CTA scanning
- Modified Rankin Scale (mRS) score greater than 3
- Refusal to sign informed consent
- Participation in other intracranial aneurysm clinical studies
- Failed or incomplete head CTA scans or poor image quality
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 21 locations
1
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
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2
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
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3
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
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4
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
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5
Shiyan People's Hospital
Shiyan, Hubei, China
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6
Research Institute Of Medical Imaging Jinling Hospital
Nanjing, Jiangsu, China, 210018
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7
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
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8
The First Hospital of Jilin University
Changchun, Jilin, China
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9
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
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10
Yidu Central Hospital Affiliated to Shandong Second Medical University
Weifang, Shandong, China
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11
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
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12
Hainan General Hospital
Haikou, China
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13
The First People's Hospital of Kashgar Region
Kashgar, China
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14
University Second Hospital
Lanzhou, China
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15
First People's Hospital of Lianyungang
Lianyungang, China
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16
Ma'anshan People's Hospital
Ma’anshan, China
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17
BenQ Medical Center, Affiliated BenQ Hospital of Medical School, Nanjing Medical University
Nanjing, China
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18
Long Gang Central Hospital of Shenzhen
Shenzhen, China
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19
The Affiliated Suqian First Hospital of Nanjing Medical University
Suqian, China
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20
Tianjin Medical University General Hospital
Tianjin, China
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21
General Hospital of Ningxia Medical University
Yinchuan, China
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Research Team
L
Longjiang Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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