Clinical Validation of an Artificial Intelligence-Based G-FAST Score in Patients With Stroke

April 15, 2026 updated by: qingfeng ma, Xuanwu Hospital, Beijing
This study aims to validate the clinical performance of an artificial intelligence (AI)-based automatic assessment system for the G-FAST score. The core comparison is the consistency and accuracy between AI-generated G-FAST results and standardized manual G-FAST assessments performed by trained professionals. The goal is to provide a convenient, efficient, and objective tool for acute stroke screening and early identification, reduce the subjective variability of manual scoring, and optimize the pre-hospital and in-hospital stroke assessment workflow.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
297

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with acute ischemic stroke who undergo G-FAST scale assessments using both AI and manual methods.

Description

Inclusion Criteria:

  1. Aged ≥ 18 years, of either sex.
  2. Clinically diagnosed with stroke, and confirmed by cranial CT/MRI to have ischemic or hemorrhagic stroke.
  3. Onset within 7 days.
  4. Alert and oriented, able to cooperate with standardized video and audio data collection.
  5. The patient or their legally authorized representative understands the study and voluntarily provides written informed consent (including consent for audio-visual data collection).

Exclusion Criteria:

  1. Neurological deficits caused by non-stroke etiologies (e.g., brain tumor, traumatic brain injury, encephalitis).
  2. Patients with impaired consciousness, severe cognitive dysfunction, or psychiatric disorders that prevent cooperation with video collection and scale assessment.
  3. Patients with severe visual or hearing impairment, or global aphasia, who are unable to follow instructions.
  4. Critically ill patients requiring immediate cardiopulmonary resuscitation or endotracheal intubation, making video and audio data collection impossible.
  5. Patients with severe facial or limb deformities, or large-area dressings that severely interfere with camera data collection.
  6. Patients with unilateral or bilateral upper limb amputation, severe deformity, unhealed fracture, joint fixation, or severe contracture.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
AI-first interview group
Participants first undergo G-FAST assessment by AI, followed by G-FAST assessment by human assessors.
Human-first group
Participants first undergo G-FAST assessment by human assessors, followed by G-FAST assessment by AI.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Agreement between AI-generated and physician-scored G-FAST scale assessments
Time Frame: within 7 days of acute stroke onset
The agreement between the scores generated by the artificial intelligence (AI) system and the scores assigned by neurologists on G-FAST scale will be evaluated using weighted Kappa coefficients.
within 7 days of acute stroke onset

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Agreement of AI System vs. Neurologists in Binary G-FAST Classification (Score ≥3 vs. <3)
Time Frame: within 7 days of acute stroke onset
Kappa coefficient will be calculated to evaluate the agreement between the artificial intelligence (AI) system and neurologist experts in the binary classification of G-FAST scale scores, defined as high risk (total score ≥3) vs. low risk (total score <3) for large vessel occlusion stroke.
within 7 days of acute stroke onset
Bland-Altman Agreement Limit Analysis
Time Frame: within 7 days of acute stroke onset
A Bland-Altman plot will be constructed, with the difference between manual scores and AI scores on the vertical axis and the mean of the two scores on the horizontal axis. The limits of agreement (mean difference ± 1.96 × standard deviation) will be calculated.
within 7 days of acute stroke onset
Diagnostic performance analysis
Time Frame: within 7 days of acute stroke onset
Taking the manual score as the gold standard, a 2×2 contingency table was constructed to calculate the sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and Youden index of the AI scoring system for stratifying the G-FAST score (LVO ≥3 vs. non-LVO <3). The ROC curve was plotted and the AUC was calculated.
within 7 days of acute stroke onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xuanwu Hospital, Beijing

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing Tiantan Hospital
Capital Medical University
The First Hospital of Fangshan District,Beijing
People's Hospital of Beijing Daxing District

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Qingfeng Ma, MD, Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • qingfeng ma G-FAST Scale

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to the protection of participant privacy and institutional review board requirements, individual participant data (IPD) will not be shared publicly.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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