Prospective Registry of Acute Ischemic Stroke in Children Under 18 Years Old in China (NCT07550257) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prospective Registry of Acute Ischemic Stroke in Children Under 18 Years Old in China
1,000 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range
28 Days – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pediatric Modified Rankin Scale (ped-mRS) Score at 90 Days
Timeframe: 90 days (±7 days) post-stroke onset
Trial details
NCT IDNCT07550257
SponsorGansu Provincial Maternal and Child Health Care Hospital
Sponsor typeOTHER
Study typeOBSERVATIONAL
Primary completion2029-05-31
Contact for this trial
Jian Liu President, Gansu Provincial Maternity and Child-Care Hospital, MD