Health Trials

Artificial Intelligence Support for Stroke

ConditionIschemic Stroke, Acute
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCapital Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

Clinical diagnosis of acute ischemic stroke.

Onset time (last known well) <24 hours.

CT or MRI examination excluding intracerebral hemorrhage.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI-assisted thrombolysis decision support

    Other intervention

    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.

Treatment groups

516 Participants
are divided into 2 treatment groups
Group A: AI-Assisted GroupExperimental treatment 1 intervention
Group B: Standard Treatment GroupNo intervention 0 interventions

Trial outcomes

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

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
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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Capital Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: