Acute Ischemic Stroke (AIS), Pediatric Stroke
Conditions
Brief summary
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.
Interventions
Participants receive routine clinical care per each center's standard practice. Treatment may include medical therapy (antiplatelet agents, anticoagulation) and/or endovascular treatment (stent retriever, aspiration thrombectomy, balloon angioplasty, stenting, or intra-arterial thrombolysis), as determined by the treating physician. No protocol-mandated intervention is applied.
Sponsors
Gansu Provincial Maternal and Child Health Care Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
28 Days to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Modified Rankin Scale (ped-mRS) Score at 90 Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients with ped-mRS 0-1, 0-2, 0-3 at 90 Days | 90 days (±7 days) post-stroke onset | Proportion of patients achieving favorable functional outcome, defined as pediatric modified Rankin Scale (ped-mRS) score of 0-1, 0-2, 0-3 at 90 days (±7 days) post-stroke onset. |
| Change in ped-NIHSS Score at 24 Hours | 24 hours (±12 hours) post-procedure | Change in pediatric National Institutes of Health Stroke Scale (ped-NIHSS) score from baseline to 24 hours (±12 hours) post-admission/post-procedure. Higher scores indicate more severe stroke. |
| Pediatric Modified Rankin Scale (ped-mRS) Score at 6 Months | 6 months (±14 days) post-stroke onset | Functional outcome assessed by ped-mRS at 6 months (±14 days) post-stroke onset. The scale ranges from 0 (no symptoms) to 6 (death). |
Contacts
CONTACTJian Liu President, Gansu Provincial Maternity and Child-Care Hospital, MD
CONTACTRong Yin Chief, Division of Neurology, MD
Outcome results
None listed