Study on the Performance of a Machine Learning Algorithm Recognizing and Triaging Large Vessel Occlusions Using Non-contrast CT Scans

Not yet recruiting

• Conditions: Stroke Hemorrhagic; Brain Ischemia; Stroke, Acute; Stroke, Ischemic
• Interventions: Device: AI software for Stroke

• Registration Number: NCT06216457
• Lead Sponsor: Methinks Software SL

Brief Summary

The goal of this prospective observational study is to assess the effectiveness and performance of Methinks AI stroke imaging software platform in acute Code Stroke patients, and as a comparator to study sites utilizing existing AI imaging stroke platforms.

The main question\[s\] it aims to answer is:

• Performance of and outcomes associated with the use of the Methinks AI stroke imaging medical device in real-world clinical practice.

Detailed Description

This is a prospective observational medical device clinical trial that aims to assess the diagnostic performance of Methinks Investigational Device on detecting LVO and ICH on plain NCCT and CTA, in consecutive acute Code Stroke activations at the emergency department.

Demographic, Clinical and Imaging variables will be collected from stroke onset through Day 7 or Discharge, whichever is earlier. Methinks results will be collected exclusively for research purposes and no clinical decisions will be made based on the output. Diagnostic performance of NCCT-LVO Methinks output will be assessed using DSA and/or CTA as ground truth. Presence of ICH will be assessed using an independent neuroradiologist final reading. The Clinical impact on workflow will be retrospectively estimated based on the reduction of time to decision in both transfer patients and the ones directly arriving to the emergency department (ED)

Informed consent forms (ICF) will be waived, as approved by the IRB.

Study Timeline

• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-27
• Last Update Posted: 2024-05-29
• Study Start: 2024-07-01
• Primary Completion: 2024-07-30
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Subjects with acute neurological symptoms suggestive of Stroke, ischemic or hemorrhagic ("Code Stroke"), regardless of presence or absence of final Stroke diagnosis.
• Subjects aged 22 years or older.
• NCCT performed for Code Stroke screening.
• If the patient does not have a hemorrhage, a CTA (head and neck, performed for Code Stroke screening) should also be performed.
• NCCT and CTA have been processed by Methinks AI software.

Exclusion Criteria

● Subject imaging does not meet Image Acquisition and DICOM Tag Requirements

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1: LVO	AI software for Stroke	Subjects with Methinks NCCT algorithm detecting ICA, M1, and M2 occlusions.
Group 3: Controls	AI software for Stroke	Subjects with final diagnosis confirmed not to be Stroke (i.e. stroke mimic) or any type of stroke not determined to be: LVO (ICA, M1 or M2) or ICH.
Group 2: ICH	AI software for Stroke	Subjects with Methinks NCCT algorithm detecting ICHs.

Primary Outcome Measures

Name	Time	Method
Evaluate the sensitivity and specificity of the following Methinks AI modules:	Baseline, pre-intervention (Code Stroke presentation and screening), During Code Stroke treatment, Immediately After the stroke treatment, Up to Discharge or 7 Days (whichever is sooner).	1. Methinks NCCT algorithm detecting ICA, M1, and M2 occlusions.; 2. Methinks NCCT algorithm detecting ICHs.; 3. Methinks CTA algorithm detecting ICA, M1, and M2 occlusions.

Secondary Outcome Measures

Name	Time	Method
Time Potential time reduction - difference in speed to LVO notification between Methinks NCCT-LVO and competitor CTA-LVO.	Baseline, pre-intervention (Code Stroke presentation and screening), During Code Stroke treatment, Immediately After the stroke treatment, Up to Discharge or 7 Days (whichever is sooner).
Time for NCCT-LVO Notification.	Baseline, pre-intervention (Code Stroke presentation and screening), During Code Stroke treatment, Immediately After the stroke treatment, Up to Discharge or 7 Days (whichever is sooner).
User experience.	1 day (Questionnaire completed at individual site enrollment completion.)	Site Principal Investigator will complete questionnaire based upon experience with use of the Methinks software and application.