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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Intracranial Aneurysm, CT Angiography, Deep Learning, Double Bind Interaction

In brief

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.

Key facts

Study ID

NCT06118840

Run by

Jinling Hospital, China

People needed

6450

Starts

2024-05-20

Expected to finish

2026-12-01

Last updated by the study team

2025-10-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adult inpatients and outpatients who are scheduled for head CTA scanning.

You may not qualify if…

• 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.

Where it is running

• The First Affiliated Hospital of University of Science and Technology of China — Hefei, Anhui, China (enrolling)
• The First Affiliated Hospital of Wannan Medical College — Wuhu, Anhui, China (enrolling)
• Guizhou Provincial People's Hospital — Guiyang, Guizhou, China (enrolling)
• First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (enrolling)
• Shiyan People's Hospital — Shiyan, Hubei, China (enrolling)
• Research Institute Of Medical Imaging Jinling Hospital — Nanjing, Jiangsu, China (enrolling)
• Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (enrolling)
• The First Hospital of Jilin University — Changchun, Jilin, China (enrolling)
• Shandong Provincial Hospital Affiliated to Shandong First Medical University — Jinan, Shandong, China (enrolling)
• Yidu Central Hospital Affiliated to Shandong Second Medical University — Weifang, Shandong, China (enrolling)
• The First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (enrolling)
• Hainan General Hospital — Haikou, China (enrolling)
• The First People's Hospital of Kashgar Region — Kashgar, China (enrolling)
• University Second Hospital — Lanzhou, China (enrolling)
• First People's Hospital of Lianyungang — Lianyungang, China (enrolling)
• Ma'anshan People's Hospital — Ma’anshan, China (enrolling)
• BenQ Medical Center, Affiliated BenQ Hospital of Medical School, Nanjing Medical University — Nanjing, China (enrolling)
• Long Gang Central Hospital of Shenzhen — Shenzhen, China (enrolling)
• The Affiliated Suqian First Hospital of Nanjing Medical University — Suqian, China (enrolling)
• Tianjin Medical University General Hospital — Tianjin, China (enrolling)
• General Hospital of Ningxia Medical University — Yinchuan, China (enrolling)

Full record on ClinicalTrials.gov

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