Artificial Intelligence Support for Stroke

Artificial Intelligence-Assisted Decision Support for Intravenous Thrombolysis in Acute Ischemic Stroke at Basic Hospitals in China (ASSIST)

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.

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.