Stroke, Acute Clinical Trial
Official title:
Comparative Observation of MeThinks AI Performance in Angiography and Non-Contrast CT Assessment.
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.
The COMPASS Registry aims to validate the Methinks AI automated Non-Contrast CT (NCCT) and Contrast Head CT (CTA) stroke imaging software. Consecutive "Code Stroke" screening NCCTs and CTAs will be processed with the Methinks technology. This is a prospective observational study, but no clinical decisions will be made based upon the Methinks results. There are 3 Cohorts: Group 1, LVO; Group 2, ICH; Group 3 Controls. Consecutive Code Stroke subjects will be enrolled. Group 1 and Group 2 will be followed through Day 7 or Discharge, whichever is sooner. Group 3 will be followed only through the Code Stroke work-up. Only minimal demographics and clinical information will be collected, with all NCCT and CTA images processed with Methinks software collected. Informed consent forms (ICF) will be waived, as approved by the IRB. ;
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