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

RecruitingNAAges 18 Years - anyAllJinling Hospital, China
NCT06118840 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult inpatients and outpatients who are scheduled for head CTA scanning. Exclusion Criteria: * 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.
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What it tests

  • True-AI-integrated intracranial aneurysms diagnosis strategy
  • Sham-AI-integrated intracranial aneurysms diagnosis strategy
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Where

21 sites
The First Affiliated Hospital of University of Science and Technology of China
Hefei, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, China
Guizhou Provincial People's Hospital
Guiyang, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Shiyan People's Hospital
Shiyan, China
Research Institute Of Medical Imaging Jinling Hospital
Nanjing, China
Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
The First Hospital of Jilin University
Changchun, China

…and 13 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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