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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJinling Hospital, China

About this trial

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

Qualifiers

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

Disqualifiers

Age under 18 years.

Patients with contraindications to CTA.

Modified Rankin Scale (mRS) score > 3.

Refuse to sign informed consent.

Trial design

Treatments tested in this trial

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

Treatment groups

6,450 Participants
are divided into 2 treatment groups

Sponsors and collaborators