This study investigates whether an AI-assisted decision support tool, compared with standard care, increases the proportion of acute ischemic stroke patients receiving intravenous thrombolysis within 24 hours of symptom onset at a primary hospital in China, while also evaluating its impact on clinical outcomes, treatment timelines, and safety.
This single-center, randomized controlled, open-label, blinded-endpoint trial aims to evaluate whether an AI-assisted decision support tool increases the proportion of acute ischemic stroke patients (onset \<24 h) receiving intravenous thrombolysis at a primary hospital in China, and to assess its impact on clinical outcomes. Using cluster randomization at the level of attending physicians , the intervention group adds the AI tool to routine assessment, while the control group follows current guidelines and standard institutional protocols; both groups are not permitted to delay routine care for research purposes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
516
The AI-assisted thrombolysis decision support tool is used by attending physicians in addition to routine stroke evaluation. After the physician enters key patient data, the system generates real-time prompts on whether the patient meets criteria for intravenous thrombolysis, recommended additional tests and risk alerts for thrombolysis. The final treatment decision remains with the treating clinician.
Liuyang Jili Hospital
Changsha, Hunan, China
RECRUITINGThe proportion of patients receiving intravenous thrombolysis.
Time frame: 24 hours within last known well
Proportion of patients with an modified Rankin Scale score (the total score ranges from 0 to 6; a higher score indicates a more severe disability) of 0-1 at 90 days
Time frame: 90 days after stroke onset
90-Day modified Rankin Scale score (the total score ranges from 0 to 6; a higher score indicates a more severe disability)
Time frame: 90 days after stroke onset
Early neurological improvement
Defined as an improvement of at least 4 points on the National Institutes of Health Stroke Scale (NIHSS, 0-42 score, a higher score indicates a more severe condition) score within 24 hours, or a score of 0.
Time frame: 24 hours after admission
Time from admission to intravenous thrombolysis (DNT) in patients receiving intravenous thrombolysis
Time frame: 24 hours within last known well
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