Stroke, Acute Clinical Trial
— SMART-LVOOfficial title:
Study on the Performance of a Machine Learning Algorithm Recognizing and Triaging Large Vessel Occlusions Using Non-contrast CT Scans
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.
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
Methinks Software SL | Santiago Ortega- global PI |
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.) |
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