Status:
ENROLLING_BY_INVITATION
A Multicenter Study to Optimize Microembolic Signal Classification Based on Double--Blind Multiparametric Assessment by Human Experts Using an Universal Graphical Interface [MESOMEGA]
Lead Sponsor:
Universidade do Porto
Collaborating Sponsors:
Sound Vascular Neurology
RISE-Heatlh
Conditions:
Microemboli
Stroke
Eligibility:
All Genders
18+ years
Brief 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. monitor...
Detailed Description
Rationale The presence of microembolic signals (MES) is a powerful predictor of future embolic events. However, MES detection is technically demanding and requires expert interpretation. Aim We aim ...
Eligibility Criteria
Inclusion
- MES of presumed solid form or non-MES high intensity transient signals
- Obtained from on a human subject with age equal to or more than 18years old
- Obtained from proximal middle cerebral artery (M1 segment)
- Clip with 20 seconds duration with clearly event of interest marked using TCDPlayer
- With an overall background spectrum of reasonable quality to be analyzed
Exclusion
- MES in gaseous form
- Use of ultrasound contrast agent or agitated saline in the previous 24 hours
- Obtained from patients with mechanical valve
- Obtained from patient during any cardiac surgery or endovascular procedure1
- Obtained from patient with recent severe trauma
- Clips with multiples inseparable MES (e.g. curtain)
Key Trial Info
Start Date :
May 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 15 2026
Estimated Enrollment :
850 Patients enrolled
Trial Details
Trial ID
NCT07172165
Start Date
May 15 2025
End Date
March 15 2026
Last Update
December 10 2025
Active Locations (1)
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1
Faculty of Medicine University Porto
Porto, Portugal, 4200-319