Construction and Evaluation of an Intelligent Decision System for Reperfusion Therapy in Acute Ischemic Stroke

NCT07316049 | Not Yet Recruiting

• 1 other identifier: LingBao
• Study Type: interventional
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

This multicenter, cluster-randomized controlled trial will evaluate the effectiveness and safety of the LingBao System, an AI-enabled clinical decision support platform for reperfusion therapy in acute ischemic stroke (AIS). Twenty certified stroke centers will be randomized 1:1 to LingBao-assisted care or standard care. Consecutive patients aged 18 years or older who present within 24 hours of symptom onset or last-known-well and are evaluated for intravenous thrombolysis and/or endovascular therapy will be prospectively enrolled. At intervention sites, clinicians may use the LingBao System during their routine workflows. The platform integrates routinely available clinical and imaging data, automatically estimates onset-to-treatment windows, screens contraindications, and provides evidence-based, guideline-concordant recommendations for reperfusion therapy; all treatment decisions remain at physician discretion. The primary endpoint is the 90-day modified Rankin Scale (mRS) score analyzed by ordinal shift. Secondary endpoints include workflow metrics (door-to-needle time and door-to-puncture time), reperfusion treatment rates, early neurological improvement, symptomatic intracranial hemorrhage, and mortality. The study plans to include approximately 20 centers (about 150 patients per center), accounting for intracluster correlation. The findings will provide real-world evidence on the clinical value of AI-assisted decision support for reperfusion therapy in AIS and inform broader implementation of intelligent stroke management systems.

Conditions

Acute Ischemic Stroke

Keywords

Reperfusion Therapy; Artificial Intelligence; Clinical Decision Support System

Outcome Measures

Primary Outcomes (1)

• Functional outcome at 90 days assessed by the modified Rankin Scale (mRS)

  Functional status at 90 days after stroke onset will be measured using the modified Rankin Scale (mRS, range 0-6). Outcomes will be analyzed as an ordinal shift across the full mRS distribution, comparing LingBao-assisted care versus standard care.

  90 days post-stroke onset

Secondary Outcomes (5)

• Door-to-Needle Time (DNT) for Intravenous Thrombolysis at baseline

  Baseline

• Door-to-Puncture Time (DPT) for Endovascular Therapy at baseline

  Baseline

• Reperfusion Treatment Rate at baseline

  Baseline

• Symptomatic Intracranial Hemorrhage (sICH) within 36 hours after treatment

  Within 36 hours after treatment

• All-Cause Mortality at 90 days post-stroke onset

  90 days post-stroke onset

Study Arms (2)

LingBao-Assisted Care

EXPERIMENTAL

Participants enrolled at stroke centers assigned to the LingBao-assisted group will receive routine clinical care for acute ischemic stroke, with optional use of the LingBao System (Stroke Reperfusion Intelligent Decision System, SRIDS) as a clinical decision support tool during evaluation and management for reperfusion therapy. The LingBao System integrates patient demographic, clinical, and imaging data; automatically estimates onset-to-treatment windows; screens contraindications; and provides guideline-concordant recommendations for intravenous thrombolysis and/or endovascular therapy with evidence grading. All final treatment decisions remain at the discretion of the treating physicians.

Other: LingBao System

Standard Care

ACTIVE COMPARATOR

Participants enrolled at stroke centers assigned to the control group will receive standard care for acute ischemic stroke according to current national and international guidelines. Clinicians in these centers will not access or use the LingBao System during the study period. All diagnostic and therapeutic decisions will follow usual institutional practice without AI-based support.

Other: Standard Care

Interventions

Standard Care OTHER

Participants at stroke centers assigned to the Standard Care arm will receive routine clinical management for acute ischemic stroke (AIS) according to current national and international guidelines.

Standard Care

LingBao System OTHER

The LingBao System is an artificial intelligence-enabled clinical decision support platform developed to assist physicians in evaluating and managing patients with acute ischemic stroke (AIS) who are candidates for reperfusion therapy. The system integrates routinely available clinical and imaging data, automatically estimates onset-to-treatment windows, screens contraindications, and displays guideline-concordant recommendations for intravenous thrombolysis and/or endovascular therapy along with corresponding evidence levels. LingBao is intended for use by trained clinicians as an informational tool within standard care pathways. It does not replace physician judgment, modify treatment protocols, or deliver any direct therapeutic intervention. LingBao will be available only at centers randomized to the intervention arm ("LingBao-Assisted Care"). Clinicians at control centers ("Standard Care") will not use the system during the study period.

Also known as: LingBao AI Decision Platform; SRIDS; Intelligent Stroke Reperfusion Decision Support System

LingBao-Assisted Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Clinical diagnosis of acute ischemic stroke (AIS).
• Presentation within 24 hours of symptom onset or last-known-well.
• Evaluated for reperfusion therapy (intravenous thrombolysis and/or endovascular treatment).
• Admission to one of the participating certified stroke centers.
• Availability of required clinical and imaging data for system evaluation and outcome assessment.

You may not qualify if:

• Absence of key clinical or imaging data necessary for analysis.
• Patients not undergoing reperfusion assessment or outside the pre-defined workflow.
• Prior participation in LingBao pilot testing or other AI-based decision support trials within the past 6 months.
• Explicit refusal of data use or withdrawal of consent (if applicable).

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an open-label cluster trial. Neither participants nor investigators are blinded to group assignment. Outcome assessment at 90 days (mRS) will be performed by trained assessors unaware of treatment allocation when feasible.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Twenty certified stroke centers will be randomized 1:1 to LingBao-assisted care or standard care.

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 5, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-10