A Multicenter Study to Optimize Microembolic Signal Classification Based on Double--Blind Multiparametric Assessment by Human Experts Using an Universal Graphical Interface [MESOMEGA]
NCT07172165 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 850
Last updated 2025-12-10
Summary
Microembolic signals (MES) is a powerful predictor of future embolic events. This study aims to develop and validate a accurate model of classification of MES obtained by transcranial Doppler. monitoring of However, MES detection is technically demanding and requires expert interpretation. By providing a reproducible framework for MES interpretation, this work aims to facilitate MES integration into future clinical trials and decision-making.
Conditions
- Microemboli
- Stroke
- Transcranial Doppler Ultrasound
Interventions
- DIAGNOSTIC_TEST
-
Expert double-blind evaluation
Expert reading will be using TCDPlayer and will be blinded to clinical data, source information, and other assessments. They will manually annotate six predefined signal features: characteristic audible signal increase, characteristic wave-like of raw Doppler signals, Emboli-to-Background Ratio, Emboli-to-Mirror Ratio, signal duration, and average velocity of maximum intensity. Analysis will be completed within 90 days.
Sponsors & Collaborators
-
Sound Vascular Neurology
collaborator UNKNOWN -
RISE-Heatlh
collaborator UNKNOWN -
CRU-RISE
collaborator UNKNOWN -
University of Ostrava
collaborator OTHER -
Maastricht University Medical Center
collaborator OTHER -
Justus-Liebig University Gießen Medical Center
collaborator UNKNOWN -
University of Bern
collaborator OTHER -
Centro Hospitalar De São João, E.P.E.
collaborator OTHER -
Houston Methodist DeBakey Heart & Vascular Center
collaborator OTHER -
Universidade do Porto
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-15
- Primary Completion
- 2025-12-15
- Completion
- 2026-03-15
Countries
- Portugal
Study Locations
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