Stepped-Wedge Cluster Randomized Trial of AI-Assisted CTA Detection for Intracranial Aneurysms in Regional Hospitals

NCT07124624 | Not Yet Recruiting DMC

• 1 other identifier: 2025DZKY-087-01
• Study Type: interventional
• Target: 14,400
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study (IDEAL 2) is a nationwide stepped-wedge cluster-randomized trial designed to prospectively enroll over 14,400 patients undergoing outpatient head CT angiography (CTA). The trial will be conducted across more than 72 regional hospitals in China. Clusters were randomly assigned to nine randomization groups. In accordance with the stepped-wedge design, clusters will sequentially transition from the control condition (standard human diagnosis) to the intervention condition (AI-assisted diagnosis) at regular intervals over a 10-month period, until all clusters receive the intervention. The primary outcome is the detection rate of intracranial aneurysms. Secondary outcomes include patient prognosis and clinical outcomes.

Conditions

Intracranial Aneurysm; CT Angiography; AI (Artificial Intelligence); Cluster Randomized Trial

Keywords

Intracranial aneurysm; AI (Artificial Intelligence); Stepped-wedge cluster-randomized trial

Outcome Measures

Primary Outcomes (1)

• Detection rate of intracranial aneurysms

  The proportion of patients diagnosed with intracranial aneurysms among all individuals undergoing CTA during the observation period. This outcome is used to compare the diagnostic effectiveness of conventional radiologist interpretation based on local clinical practice versus AI-assisted diagnosis in detecting intracranial aneurysms.

  Day 1

Secondary Outcomes (11)

• Detection rates of other intracranial lesions except aneurysms

  Day 1

• Follow-up visits and referrals

  At 3-month and 12-month follow-up.

• Hospitalization

  At 3-month and 12-month follow-up.

• Invasive DSA examinations

  At 3-month and 12-month follow-up.

• Aneurysm treatment decisions

  At 3-month and 12-month follow-up.

Study Arms (2)

AI-Assisted Diagnosis

EXPERIMENTAL

Patients in this group will undergo head CTA, interpreted by radiologists with the assistance of a previously validated deep learning AI model. The model highlights suspected aneurysm candidates on the CTA images to support diagnostic decision-making.

Device: AI-Assisted CTA Interpretation

Standard Diagnosis

ACTIVE COMPARATOR

Patients in this group will undergo head CTA, which will be interpreted by radiologists following standard local diagnostic protocols. No AI assistance will be provided during image interpretation.

Diagnostic Test: Standard CTA Interpretation

Interventions

AI-Assisted CTA Interpretation DEVICE

A locked, independently validated deep learning model was used to assist radiologists in interpreting head CTA scans. The model was trained on 16,546 CTA cases and externally validated on an independent set of 900 DSA-verified CTA cases, achieving a patient-level sensitivity of 0.943 and an average of 0.187 false positives per case.

AI-Assisted Diagnosis

Standard CTA Interpretation DIAGNOSTIC_TEST

Head CTA interpretation performed by radiologists using local routine diagnostic workflows without AI support.

Standard Diagnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in the outpatient setting who are scheduled to undergo head CTA scanning

You may not qualify if:

• Age \< 18 years
• History of cerebrovascular surgery involving any metallic implants (e.g., aneurysm embolization, aneurysm clipping, or vascular stenting)
• Modified Rankin Scale (mRS) score \> 3
• Refuse to sign written informed consent
• Contraindications to CTA examination
• CTA scan failure, incomplete imaging data, or image quality insufficient for diagnostic evaluation

Sponsors & Collaborators

• Jinling Hospital, China: lead

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Longjiang Zhang, Ph.D, MD

CONTACT

+8613405833176; kevinzhlj@163.com

Bin Hu, MS

CONTACT

+8618851088705; hubin011601@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Radiology

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 15, 2025
• Study Start: October 9, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2029
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share