NCT06118840 IDEAL Study: Blinded RCT for the Impact of AI Model for Cerebral Aneurysms Detection on Patients' Diagnosis and Outcomes
| NCT ID | NCT06118840 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jinling Hospital, China |
| Condition | Intracranial Aneurysm |
| Study Type | INTERVENTIONAL |
| Enrollment | 6,450 participants |
| Start Date | 2024-05-20 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 6,450 participants in total. It began in 2024-05-20 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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.
Contact & Investigator
Trial Manager
PRINCIPAL INVESTIGATOR
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
Frequently Asked Questions
Who can join the NCT06118840 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intracranial Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06118840 currently recruiting?
Yes, NCT06118840 is actively recruiting participants. Contact the research team at kevinzhlj@163.com for enrollment information.
Where is the NCT06118840 trial being conducted?
This trial is being conducted at Hefei, China, Wuhu, China, Guiyang, China, Zhengzhou, China and 11 additional locations.
Who is sponsoring the NCT06118840 clinical trial?
NCT06118840 is sponsored by Jinling Hospital, China. The principal investigator is Trial Manager at Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University. The trial plans to enroll 6,450 participants.