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

No results posted yet for this study

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07172165 on ClinicalTrials.gov