NCT07785492

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
516

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Aug 2026Mar 2027

First Submitted

Initial submission to the registry

August 15, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

August 26, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 15, 2026

Last Update Submit

August 26, 2026

Conditions

Ischemic Stroke, Acute

Keywords

Randomized Controlled TrialStrokeAIThrombolysis

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients receiving intravenous thrombolysis.

    24 hours within last known well

Secondary Outcomes (4)

  • 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

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

    24 hours within last known well

Other Outcomes (3)

  • Proportion of symptomatic intracranial hemorrhage within 36 hours of thrombolysis

    within 36 hours of thrombolysis

  • Proportion of any type of intracranial hemorrhage within 36 hours of thrombolysis

    within 36 hours of thrombolysis

  • 90-day all-cause mortality rate.

    90 days after stroke onset

Study Arms (2)

AI-Assisted Group

EXPERIMENTAL

Patients receive care from attending physicians who use the AI-assisted thrombolysis decision support tool in addition to routine assessment, with the final treatment decision left to the physician's clinical judgment.

Other: AI-assisted thrombolysis decision support

Standard Treatment Group

NO INTERVENTION

Patients receive standard acute ischemic stroke care according to the hospital's current protocols without the use of the AI tool.

Interventions

AI-assisted thrombolysis decision supportOTHER

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.

AI-Assisted Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liuyang Jili Hospital

Changsha, Hunan, China

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Xunming Ji

CONTACT

01083198962jixm@ccmu.edu.cn

Chuanjie Wu

CONTACT

01083199439wuchuanjie@ccmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology, Xuanwu Hospital, Capital Medical University

Study Record Dates

First Submitted

August 15, 2026

First Posted

August 25, 2026

Study Start

August 26, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

August 27, 2026

Record last verified: 2026-08

Locations

CN(1)