Study on the Performance of a Machine Learning Algorithm Recognizing and Triaging Large Vessel Occlusions Using Non-contrast CT Scans
NCT ID: NCT06216457
Last Updated: 2024-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
5000 participants
OBSERVATIONAL
2024-07-01
2024-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1: LVO
Subjects with Methinks NCCT algorithm detecting ICA, M1, and M2 occlusions.
AI software for Stroke
AI Software for Non-Contrast Head CT (Computed Tomography) and CT Angiography, utilized for Code Stroke screening, notification and triage.
Group 2: ICH
Subjects with Methinks NCCT algorithm detecting ICHs.
AI software for Stroke
AI Software for Non-Contrast Head CT (Computed Tomography) and CT Angiography, utilized for Code Stroke screening, notification and triage.
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.
AI software for Stroke
AI Software for Non-Contrast Head CT (Computed Tomography) and CT Angiography, utilized for Code Stroke screening, notification and triage.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
22 Years
ALL
No
Sponsors
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Santiago Ortega- global PI
UNKNOWN
Methinks Software SL
INDUSTRY
Responsible Party
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Central Contacts
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Related Links
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Sponsor website
Other Identifiers
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SMART-LVO Registry
Identifier Type: -
Identifier Source: org_study_id
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