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

Stroke, Acute Clinical Trial

— SMART-LVO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06216457
• Other study ID #: SMART-LVO Registry
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: May 2024
• Source: Methinks Software SL
• Contact: Carlotta Calvi
• Phone: +34639041147
• Email: research[@]methinks.ai
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: October 31, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Subjects with acute neurological symptoms suggestive of Stroke, ischemic or hemorrhagic ("Code Stroke"), regardless of presence or absence of ?nal 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

Related Conditions & MeSH terms

• Brain Ischemia
• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke
• Stroke Hemorrhagic
• Stroke, Acute
• Stroke, Ischemic

Intervention

Device:
• AI software for Stroke
AI Software for Non-Contrast Head CT (Computed Tomography) and CT Angiography, utilized for Code Stroke screening, notification and triage.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Methinks Software SL	Santiago Ortega- global PI

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the sensitivity and specificity of the following Methinks AI modules:	Methinks NCCT algorithm detecting ICA, M1, and M2 occlusions.; Methinks NCCT algorithm detecting ICHs.; Methinks CTA algorithm detecting ICA, M1, and M2 occlusions.	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).
Secondary	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).
Secondary	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).
Secondary	User experience.	Site Principal Investigator will complete questionnaire based upon experience with use of the Methinks software and application.	1 day (Questionnaire completed at individual site enrollment completion.)

External Links

•   Sponsor website