Prospective Registry of Acute Ischemic Stroke in Children Under 18 Years Old in China (KIDS-AIS-REGISTRY)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 主要终点
- Pediatric Modified Rankin Scale (ped-mRS) Score at 90 Days
研究概览
简要总结
This observational study aims to investigate the real-world effectiveness and safety of different treatment strategies for acute ischemic stroke (AIS) in Chinese children under 18 years of age.
Its primary research question is: In real-world clinical practice, does endovascular therapy (e.g., stent retriever thrombectomy, aspiration thrombectomy) improve 90-day functional outcomes in pediatric AIS patients with acute anterior or posterior circulation large vessel occlusion? Children under 18 years of age receiving routine AIS diagnosis and treatment at approximately 25-35 study centers across China will undergo neurological function assessments, imaging examinations, and evaluations of growth, development, and psychosocial status at baseline, 24 hours post-procedure, 7 days post-procedure or at hospital discharge, and at 90 days and 6 months post-onset. Adverse events will also be documented.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 28 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >28 days and <18 years;
- •Presence of stroke-related symptoms (hemiparesis, facial palsy, aphasia, altered level of consciousness, seizure, headache) or atypical symptoms (sudden lethargy or irritability, crying, feeding difficulties, incontinence, sensory loss, ataxia, vertigo, nausea and/or vomiting, neck pain, fever);
- •First-ever stroke and onset within ≤7 days prior to admission;
- •Acute ischemic stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI);
- •Legal guardian provides signed informed consent;
- •For children aged ≥8 years to <18 years who are conscious and without comprehension impairment, assent obtained from the child;
排除标准
- •Lack of imaging examination or stroke diagnosed without imaging
- •History of hypoxic-ischemic encephalopathy
- •Ischemic stroke caused by cerebral venous system
- •Concurrent presence of indistinguishable ischemic and hemorrhagic stroke
研究组 & 干预措施
All eligible children aged 28 days to <18 years with acute ischemic stroke (AIS) enrolled consecutiv
All eligible children aged 28 days to <18 years with acute ischemic stroke (AIS) enrolled consecutively from approximately 25-35 participating centers in China. Patients receive standard clinical management without treatment restrictions. Data collected include baseline demographics, clinical presentation, treatment strategies (medical therapy alone or endovascular treatment including stent retrieval, aspiration, balloon angioplasty, stenting, or intra-arterial thrombolysis), imaging parameters, safety outcomes, and functional outcomes assessed by pediatric modified Rankin Scale (ped-mRS) at 90 days and 6 months.
干预措施: Standard Clinical Management (Other)
结局指标
主要结局
Pediatric Modified Rankin Scale (ped-mRS) Score at 90 Days
时间窗: 90 days (±7 days) post-stroke onset
Primary Outcome Measure assessed by the pediatric modified Rankin Scale (ped-mRS) at 90 days (±7 days) post-stroke onset. The ped-mRS is a 7-point ordinal scale (0=no symptoms to 6=death). The full ordinal distribution of scores will be analyzed as the primary efficacy endpoint.
次要结局
- Proportion of Patients with ped-mRS 0-1, 0-2, 0-3 at 90 Days(90 days (±7 days) post-stroke onset)
- Change in ped-NIHSS Score at 24 Hours(24 hours (±12 hours) post-procedure)
- Pediatric Modified Rankin Scale (ped-mRS) Score at 6 Months(6 months (±14 days) post-stroke onset)