Ischemic Stroke, Acute
Conditions
Keywords
Randomized Controlled Trial, Stroke, AI, Thrombolysis
Brief summary
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.
Detailed description
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.
Interventions
OTHERAI-assisted thrombolysis decision support
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.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years. 2. Clinical diagnosis of acute ischemic stroke. 3. Onset time (last known well) \<24 hours. 4. CT or MRI examination excluding intracerebral hemorrhage. 5. Signed informed consent by the patient or a legally authorized representative
Exclusion criteria
1. Currently participating in another interventional clinical trial related to drugs or devices. 2. Pregnant women. 3. Has received intravenous thrombolysis at another hospital. 4. Has completed a definitive reperfusion therapy decision at another hospital and is transferred to this hospital solely for follow-up observation or rehabilitation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients receiving intravenous thrombolysis. | 24 hours within last known well |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) | 90 days after stroke onset | — |
| Early neurological improvement | 24 hours after admission | 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 from admission to intravenous thrombolysis (DNT) in patients receiving intravenous thrombolysis | 24 hours within last known well | — |
Countries
China
Contacts
CONTACTXunming Ji
CONTACTChuanjie Wu
Outcome results
None listed