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

Launched by JINLING HOSPITAL, CHINA · Nov 1, 2023

Keywords

ClinConnect Summary

The IDEAL Study is a research trial designed to see how well an artificial intelligence (AI) model can help detect brain aneurysms during a special type of scan called CT angiography (CTA). The study will involve over 6,800 patients who are scheduled for these scans at various hospitals across China. Participants will be randomly placed into two groups: one that uses the AI model and another that does not, and neither the patients nor the doctors will know which group they are in. The main goals of the study are to see how accurately the AI can find aneurysms and to understand how this affects patients' overall health and recovery.

To be eligible for this study, participants need to be adults (18 years or older) who are going to have a head CTA scan at one of the participating hospitals. Some people may not qualify if they have certain health conditions, refuse to participate, or if their scan data is not usable. If you take part in this study, you can expect to have a CT scan as usual, and your results will help researchers learn more about the potential benefits of using AI in medical imaging. This could ultimately lead to earlier detection and better treatment for patients with brain aneurysms.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients in the outpatient setting who are scheduled to undergo head CTA scanning in 25 hospitals in more than 10 provinces in China.
• 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.