[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617240":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":30,"locations":30,"responsibleParty":31,"collaborators":30,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":37,"acronym":30,"eligibilityCriteria":38,"healthyVolunteers":35,"sex":39,"minAge":40,"maxAge":30,"enrollmentInfo":41,"targetDuration":30,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":50,"overallStatus":54,"whyStopped":30,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":30},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LingBao-Assisted Care","EXPERIMENTAL","Participants enrolled at stroke centers assigned to the LingBao-assisted group will receive routine clinical care for acute ischemic stroke, with optional use of the LingBao System (Stroke Reperfusion Intelligent Decision System, SRIDS) as a clinical decision support tool during evaluation and management for reperfusion therapy.\n\nThe LingBao System integrates patient demographic, clinical, and imaging data; automatically estimates onset-to-treatment windows; screens contraindications; and provides guideline-concordant recommendations for intravenous thrombolysis and\u002For endovascular therapy with evidence grading. All final treatment decisions remain at the discretion of the treating physicians.",[13],"Other: LingBao System",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care","ACTIVE_COMPARATOR","Participants enrolled at stroke centers assigned to the control group will receive standard care for acute ischemic stroke according to current national and international guidelines.\n\nClinicians in these centers will not access or use the LingBao System during the study period. All diagnostic and therapeutic decisions will follow usual institutional practice without AI-based support.",[19],"Other: Standard Care",[21,27],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"LingBao System","The LingBao System is an artificial intelligence-enabled clinical decision support platform developed to assist physicians in evaluating and managing patients with acute ischemic stroke (AIS) who are candidates for reperfusion therapy.\n\nThe system integrates routinely available clinical and imaging data, automatically estimates onset-to-treatment windows, screens contraindications, and displays guideline-concordant recommendations for intravenous thrombolysis and\u002For endovascular therapy along with corresponding evidence levels.\n\nLingBao is intended for use by trained clinicians as an informational tool within standard care pathways. It does not replace physician judgment, modify treatment protocols, or deliver any direct therapeutic intervention.\n\nLingBao will be available only at centers randomized to the intervention arm (\"LingBao-Assisted Care\"). Clinicians at control centers (\"Standard Care\") will not use the system during the study period.",[9],[26],"LingBao AI Decision Platform; SRIDS; Intelligent Stroke Reperfusion Decision Support System",{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Participants at stroke centers assigned to the Standard Care arm will receive routine clinical management for acute ischemic stroke (AIS) according to current national and international guidelines.",[15],null,{"type":32,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100617240","construction-and-evaluation-of-an-intelligent-decision-system-for-reperfusion-therapy-in-acute-ischemic-stroke-100617240",false,"NCT07316049","Construction and Evaluation of an Intelligent Decision System for Reperfusion Therapy in Acute Ischemic Stroke","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Clinical diagnosis of acute ischemic stroke (AIS).\n* Presentation within 24 hours of symptom onset or last-known-well.\n* Evaluated for reperfusion therapy (intravenous thrombolysis and\u002For endovascular treatment).\n\nExclusion Criteria:\n\n* Absence of key clinical or imaging data necessary for analysis.\n* Patients not undergoing reperfusion assessment or outside the pre-defined workflow.\n* Prior participation in other AI-based decision support trials within the past 12 months.\n* Explicit refusal of data use or withdrawal of consent (if applicable).","ALL","18 Years",{"count":42,"type":43},3000,"ESTIMATED","INTERVENTIONAL",[46],"NA","This multicenter, cluster-randomized controlled trial will evaluate the effectiveness and safety of the LingBao System, an AI-enabled clinical decision support platform for reperfusion therapy in acute ischemic stroke (AIS). Twenty certified stroke centers will be randomized 1:1 to LingBao-assisted care or standard care. Consecutive patients aged 18 years or older who present within 24 hours of symptom onset or last-known-well and are evaluated for intravenous thrombolysis and\u002For endovascular therapy will be prospectively enrolled.\n\nThe study initially plans to enroll approximately 3,000 patients from about 20 certified stroke centers, with approximately 150 patients per center. Because this is a cluster-randomized trial, a pre-specified blinded sample size re-estimation will be performed after approximately 40% of participants have completed the 90-day mRS assessment. The re-estimation will be based only on pooled, blinded information, including cluster size, cluster-size variability, intracluster correlation, follow-up completeness, missingness of the primary outcome, and the overall distribution of the 90-day mRS. No between-group treatment effect will be examined, and any sample size adjustment will only allow an increase in enrollment.\n\nAt intervention sites, clinicians may use the LingBao System during their routine workflows. The platform integrates routinely available clinical and imaging data, automatically estimates onset-to-treatment windows, screens contraindications, and provides evidence-based, guideline-concordant recommendations for reperfusion therapy; all treatment decisions remain at physician discretion.\n\nThe primary endpoint is the 90-day modified Rankin Scale (mRS) score analyzed by ordinal shift. Secondary endpoints include workflow metrics (door-to-needle time and door-to-puncture time), reperfusion treatment rates, early neurological improvement, symptomatic intracranial hemorrhage, and mortality.\n\nThe findings will provide real-world evidence on the clinical value of AI-assisted decision support for reperfusion therapy in AIS and inform broader implementation of intelligent stroke management systems.",[49],"Acute Ischemic Stroke",[51,52,53],"Reperfusion Therapy","Artificial Intelligence","Clinical Decision Support System","NOT_YET_RECRUITING","2026-06-02",{"date":57,"type":58},"2026-06-04","ACTUAL",{"date":60,"type":43},"2026-06-15",{"date":62,"type":43},"2027-02-28",{"name":5,"class":6}]