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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 14,400
- 主要终点
- Detection rate of intracranial aneurysms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients in the outpatient setting who are scheduled to undergo head CTA scanning
排除标准
- •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
研究组 & 干预措施
AI-Assisted Diagnosis
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.
干预措施: AI-Assisted CTA Interpretation (Device)
Standard Diagnosis
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.
干预措施: Standard CTA Interpretation (Diagnostic Test)
结局指标
主要结局
Detection rate of intracranial aneurysms
时间窗: Day 1
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.
次要结局
- Postoperative complications(At 3-month and 12-month follow-up.)
- All-cause mortality(At 3-month and 12-month follow-up.)
- Aneurysm-related events during follow-up(At 12-month follow-up.)
- Intraoperative complications(At 3-month and 12-month follow-up.)
- Follow-up visits and referrals(At 3-month and 12-month follow-up.)
- Hospitalization(At 3-month and 12-month follow-up.)
- Postoperative complications(At 3-month and 12-month follow-up.)
- In-hospital morbidity(At 3-month and 12-month follow-up.)
- In-hospital mortality(At 3-month and 12-month follow-up.)
- All-cause mortality(At 3-month and 12-month follow-up.)
- Aneurysm-related events during follow-up(At 12-month follow-up.)
- Detection rates of other intracranial lesions except aneurysms(Day 1)
- Invasive DSA examinations(At 3-month and 12-month follow-up.)
- Aneurysm treatment decisions(At 3-month and 12-month follow-up.)
- Intraoperative complications(At 3-month and 12-month follow-up.)
研究者
Zhang longjiang,MD
Head of Radiology
Jinling Hospital, China