Status:
RECRUITING
IDEAL Study: Blinded RCT for the Impact of AI Model for Cerebral Aneurysms Detection on Patients' Diagnosis and Outcomes
Lead Sponsor:
Jinling Hospital, China
Conditions:
Intracranial Aneurysm
CT Angiography
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
A multicenter, prospective, double-blind, randomized controlled trial will be conducted (IDEAL study). Patients who are scheduled to undergo cranial CT angiography (CTA) scanning will be randomly divi...
Eligibility Criteria
Inclusion
- Adult inpatients and outpatients who are scheduled for head CTA scanning.
Exclusion
- Age under 18 years.
- Patients with contraindications to CTA.
- Modified Rankin Scale (mRS) score \> 3.
- Refuse to sign informed consent.
- Participation in other clinical studies of intracranial aneurysms.
- Patients with failed head CTA scanning or incomplete image data, or poor image quality.
Key Trial Info
Start Date :
May 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
6450 Patients enrolled
Trial Details
Trial ID
NCT06118840
Start Date
May 20 2024
End Date
December 1 2026
Last Update
October 7 2025
Active Locations (21)
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1
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
2
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
3
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
4
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China