MRI-based Artificial Intelligence Software (NNS-SOT) for Onset Time Estimation in Lesion With Acute Ischemic Stroke

Nunaps

Status: Completed

Conditions: Acute Ischemic Stroke

Study type: Observational

Funder types: Industry

Identifiers

NCT06160726

NNS-SOT-01

Details and patient eligibility

About

This study evaluates the efficacy of investigational device named Stroke Onset Time Artificial Intelligence(AI) (Model name:NNS-SOT). Using the investigational device, analyze the image and the onset time of occurrence of acute ischemic stroke lesion on the brain image (4.5 hours or more from the onset of symptoms) and evaluate the efficacy of correctly estimating the onset time.

Full description

This clinical trial software medical device (Model name: NNS-SOT) is developed based on artificial intelligence algorithms.

Through clinical validation, it will be easier to determine whether the golden hour (4.5 hours) has elapsed at the time of cerebral infarction in the medical field. It can be used for estimation of the onset time of occurrence in acute ischemic stroke.

Enrollment: 474 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Brain imaging in patients with acute ischemic stroke aged 20 years and older
• Brain imaging of ischemic stroke manifestation lesion confirmed by medical staff in brain MR image
• Brain imaging taken within 24 hours of ischemic stroke symptoms
• Brain imaging including Magnetic Resonance(MR) images (DWI and FLAIR)
• Patients with clearly recorded onset time of acute ischemic stroke symptoms

Exclusion criteria

• Brain imaging used in NNS-SOT development process
• Brain imaging with noise (Artifact)
• Brain images damaged in data