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

May 27, 2024 updated by: Methinks Software SL

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

5000

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

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Consecutive Code Stroke patients, aged 22 or older, regardless of presence or absence of ultimate diagnosis of Ischemic Stroke or Hemorrhagic Stroke.

Description

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 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
Intervention / Treatment
Group 1: LVO
Subjects with Methinks NCCT algorithm detecting ICA, M1, and M2 occlusions.
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.
Other Names:
  • Methinks AI Software
Group 2: ICH
Subjects with Methinks NCCT algorithm detecting ICHs.
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.
Other Names:
  • Methinks AI Software
Group 3: Controls
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.
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.
Other Names:
  • Methinks AI Software

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the sensitivity and specificity of the following Methinks AI modules:
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Potential time reduction - difference in speed to LVO notification between Methinks NCCT-LVO and competitor CTA-LVO.
Time Frame: 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).
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.
Time Frame: 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).
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.
Time Frame: 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.
1 day (Questionnaire completed at individual site enrollment completion.)

Collaborators and Investigators

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

Sponsor

Methinks Software SL

Collaborators

Santiago Ortega- global PI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

July 1, 2024

Primary Completion (Estimated)

July 30, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 27, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMART-LVO Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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