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NCT Number: NCT07785492

Artificial Intelligence Support for Stroke

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.

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Key information

Conditions

Ischemic Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liuyang Jili Hospital

Changsha, Hunan, China

Location status: Recruiting

Location contact

Yong He

CONTACT

073183615622

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years.
  • Clinical diagnosis of acute ischemic stroke.
  • Onset time (last known well) <24 hours.
  • CT or MRI examination excluding intracerebral hemorrhage.
  • Signed informed consent by the patient or a legally authorized representative

Exclusion criteria

  • Currently participating in another interventional clinical trial related to drugs or devices.
  • Pregnant women.
  • Has received intravenous thrombolysis at another hospital.
  • Has completed a definitive reperfusion therapy decision at another hospital and is transferred to this hospital solely for follow-up observation or rehabilitation.

Treatment and study plan

AI-assisted thrombolysis decision support

Other

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.

Primary outcomes

  1. The proportion of patients receiving intravenous thrombolysis.

    Time frame: 24 hours within last known well

Secondary outcomes

  1. 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

  2. 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

  3. Early neurological improvement

    Time frame: 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.

  4. Time from admission to intravenous thrombolysis (DNT) in patients receiving intravenous thrombolysis

    Time frame: 24 hours within last known well

Other outcomes

  1. Proportion of symptomatic intracranial hemorrhage within 36 hours of thrombolysis

    Time frame: within 36 hours of thrombolysis

  2. Proportion of any type of intracranial hemorrhage within 36 hours of thrombolysis

    Time frame: within 36 hours of thrombolysis

  3. 90-day all-cause mortality rate.

    Time frame: 90 days after stroke onset

Study contacts

Contact information is provided by the study sponsor or research team.

Chuanjie Wu

CONTACT

[email protected]

01083199439

Xunming Ji

CONTACT

[email protected]

01083198962

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 25, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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