A Multicenter Study to Optimize Microembolic Signal Classification Based on Double--Blind Multiparametric Assessment by Human Experts Using an Universal Graphical Interface [MESOMEGA]
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.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
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 Criteria:
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)
Primary outcome measure(s)
Classification of each signal as MES or Non-MES — From enrollment until December of 2026 A MES or non-MES will be considered as such the two experts agree. If the two experts do not agree, a special board (RA, WM) will decide on classification. "Recordings that remain undetermined, or those classified as undetermined by both experts, will be excluded from the primary analysis of this study. All experts will be blinded to each other, any identification tag or clinical information. We will include five predictors in the primary analysis which are: the presence of characteristic audible signal increase, characteristic wave-like raw Doppler signals, the Emboli-to-Background Ratio (EBR), Emboli-to-mirror-ratio (EMR), time length and average velocity of maximum intensity. The calculation and definition of each predictor is detailed in table 3 and in supplemental information (Proposal for a systematic analysis and reporting of microembolic signal detection of the Microembolic Signal Detection Working Groups of the World Organization of Neurosonology).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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