Stepped-Wedge Cluster Randomized Trial of AI-Assisted CTA Detection for Intracranial Aneurysms in Regional Hospitals
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI-Assisted CTA Interpretation, Standard CTA Interpretation.
- Who it may be relevant to
- Registry conditions: Intracranial Aneurysm, CT Angiography, AI (Artificial Intelligence), Cluster Randomized Trial. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of an AI-Driven CT Angiography Model on Intracranial Aneurysm Detection and Clinical Outcomes in Regional Hospitals (IDEAL2): A Nationwide Stepped-Wedge Cluster-Randomized Trial
Overview
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.
Detailed description
A multicenter, stepped-wedge cluster-randomized trial will be conducted in regional hospitals, specifically prefecture-level and county-level institutions across China. Each cluster (i.e., hospital) will enroll approximately 200 patients undergoing head computed tomography angiography (CTA), yielding a total sample size of at least 14,400 participants. The trial consists of nine steps, each lasting one month. Clusters will transition sequentially from the control condition to the intervention condition based on stratified randomization, until all clusters have received the intervention.
In the control group, diagnoses and treatments will follow local standard clinical protocols. In the intervention group, diagnostic procedures will be supported by an artificial intelligence (AI)-assisted system. The primary outcome is the detection rate of intracranial aneurysms, as determined from radiology reports at the patient level. Secondary outcomes include additional diagnostic performance metrics on CTA, such as the detection of intracranial arterial stenosis, occlusion, and tumors.
Follow-up evaluations at 3 and 12 months will assess treatment-related indicators-including repeat head CTA or magnetic resonance angiography (MRA), hospitalization rates, and digital subtraction angiography (DSA) utilization-as well as clinical outcomes related to aneurysm events. These measures aim to evaluate both the short- and long-term impacts of AI-assisted diagnosis on routine clinical practice and patient prognosis.
Interventions
- Device AI-Assisted CTA Interpretation
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. - Diagnostic test Standard CTA Interpretation
Head CTA interpretation performed by radiologists using local routine diagnostic workflows without AI support.
Primary outcome measures
- Detection rate of intracranial aneurysms [Time frame: Day 1]
Secondary outcome measures (11)
- Detection rates of other intracranial lesions except aneurysms [Time frame: Day 1]
- Follow-up visits and referrals [Time frame: At 3-month and 12-month follow-up.]
- Hospitalization [Time frame: At 3-month and 12-month follow-up.]
- Invasive DSA examinations [Time frame: At 3-month and 12-month follow-up.]
- Aneurysm treatment decisions [Time frame: At 3-month and 12-month follow-up.]
- Intraoperative complications [Time frame: At 3-month and 12-month follow-up.]
- Postoperative complications [Time frame: At 3-month and 12-month follow-up.]
- In-hospital morbidity [Time frame: At 3-month and 12-month follow-up.]
- In-hospital mortality [Time frame: At 3-month and 12-month follow-up.]
- All-cause mortality [Time frame: At 3-month and 12-month follow-up.]
- Aneurysm-related events during follow-up [Time frame: At 12-month follow-up.]
Eligibility criteria
Inclusion criteria
-Patients in the outpatient setting who are scheduled to undergo head CTA scanning
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07124624 · 2025DZKY-087-01