IDEAL Study: Blinded RCT for the Impact of AI Model for Cerebral Aneurysms

Status Not yet recruiting

Clinical Trial Summary

This study (IEDAL study) intends to prospectively enroll more than 6800 patients who will undergo head CT angiography (CTA) scanning in the outpatient clinic. It will be carried out in 25 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.

Clinical Trial Description

A multicenter, prospective, double-blind, randomized controlled trial will be conducted (IDEAL study). Patients who are scheduled to undergo cranial CT angiography (CTA) scanning will be randomly divided into two groups with a ratio of 1:1, one of the group will be assigned to True-AI aided intracranial aneurysms diagnosis strategy (True-AI group) and the other will be assigned to Sham-AI aided intracranial aneurysms diagnosis strategy (Sham-AI group, which has a sensitivity close to 0% and a similar specificity to True-AI). The primary outcomes are diagnostic sensitivity and specificity of detecting aneurysms. Secondary endpoints include other diagnostic performance indexes for intracranial aneurysms; diagnostic performances for other intracranial lesions for intracranial arterial stenosis, occlusion, and intracranial tumors; detection rates of intracranial lesions according to Radiology Reports; workload of head CTA interpretation; resource use; treatment-related indexes during patient follow-up (e.g. clinical follow-up, hospitalization, rate of patients undergoing DSA); life quality; outcomes of aneurysm-related events; repeat head CTA or MRA at 12-month follow; cost-effectiveness analysis between intervention and control arm to evaluate the short- and longterm influence of AI system to the routine practice and patients' prognosis and outcomes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06118840
Study type	Interventional
Source	Jinling Hospital, China
Contact	Longjiang Zhang, MD
Phone	+8613405833176
Email	kevinzhlj@163.com
Status	Not yet recruiting
Phase	N/A
Start date	December 2023
Completion date	July 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms