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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke, Acute
• Intervention / Treatment: Other: AI-assisted thrombolysis decision support

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.

• Study Type: Interventional
• Enrollment (Estimated): 516
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xunming Ji; Phone Number: 01083198962; Email: jixm@ccmu.edu.cn
• Study Contact Backup: Name: Chuanjie Wu; Phone Number: 01083199439; Email: wuchuanjie@ccmu.edu.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Liuyang Jili Hospital
      • Contact: Yong He; Phone Number: 073183615622

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-Assisted Group; 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; 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.
No Intervention: Standard Treatment Group; Patients receive standard acute ischemic stroke care according to the hospital's current protocols without the use of the AI tool.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients receiving intravenous thrombolysis.	24 hours within last known well

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	24 hours after admission
Time from admission to intravenous thrombolysis (DNT) in patients receiving intravenous thrombolysis		24 hours within last known well

Other Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: August 15, 2026
• First Submitted That Met QC Criteria: August 23, 2026
• First Posted (Actual): August 25, 2026

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 26, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Randomized Controlled Trial; AI; Thrombolysis
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Stroke
• Other Study ID Numbers: ASSIST

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No