Stepped-Wedge Cluster Randomized Trial of AI-Assisted CTA Detection for Intracranial Aneurysms in Regional Hospitals
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: AI-Assisted CTA Interpretation, Standard CTA Interpretation.
- Кому может быть актуально
- Состояния в реестре: Intracranial Aneurysm, CT Angiography, AI (Artificial Intelligence), Cluster Randomized Trial. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
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- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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.
Подробное описание
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.
Вмешательства
- Устройство 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. - Диагностический тест Standard CTA Interpretation
Head CTA interpretation performed by radiologists using local routine diagnostic workflows without AI support.
Первичные конечные точки
- Detection rate of intracranial aneurysms [Срок оценки: Day 1]
Вторичные конечные точки (11)
- Detection rates of other intracranial lesions except aneurysms [Срок оценки: Day 1]
- Follow-up visits and referrals [Срок оценки: At 3-month and 12-month follow-up.]
- Hospitalization [Срок оценки: At 3-month and 12-month follow-up.]
- Invasive DSA examinations [Срок оценки: At 3-month and 12-month follow-up.]
- Aneurysm treatment decisions [Срок оценки: At 3-month and 12-month follow-up.]
- Intraoperative complications [Срок оценки: At 3-month and 12-month follow-up.]
- Postoperative complications [Срок оценки: At 3-month and 12-month follow-up.]
- In-hospital morbidity [Срок оценки: At 3-month and 12-month follow-up.]
- In-hospital mortality [Срок оценки: At 3-month and 12-month follow-up.]
- All-cause mortality [Срок оценки: At 3-month and 12-month follow-up.]
- Aneurysm-related events during follow-up [Срок оценки: At 12-month follow-up.]
Критерии участия
Критерии включения
-Patients in the outpatient setting who are scheduled to undergo head CTA scanning
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07124624 · 2025DZKY-087-01