Prospective Registry of Acute Ischemic Stroke in Children Under 18 Years Old in China

Prospective Registry of Acute Ischemic Stroke in Children Under 18 Years Old in China (KIDS-AIS-REGISTRY)

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.

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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