Conditions

Microemboli Stroke Transcranial Doppler Ultrasound

Keywords

microembolic signals (MES)decision treestrokemicroembolitranscranial Dopplerdiagnostic standardprediction model

Outcome Measures

Primary Outcomes (1)

Classification of each signal as MES or Non-MES
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).
From enrollment until December of 2026

Secondary Outcomes (4)

Trimmed version of the model
From enrollment until December of 2026

Study Arms (1)

Transcranial Doppler clips database

Clips of MES and non-MES events. Each clip will be 20 seconds (-10 and +10 seconds in reference to the marked event). The data presented will not be modified from its original form. The final database that will be used for expert evaluation will include the necessary clips and proportions to ensure maximum reproducibility and generalization of the data. Clips will be obtained from at least 3 different types or brands of TCD machines. A single machine cannot be the source of more than 50% of the final data set. MES will be from a variety of sources including patients with atherosclerotic disease, cardioembolic stroke, or embolic stroke of unknown source.

Diagnostic Test: Expert double-blind evaluation

Interventions

Expert double-blind evaluationDiagnostic test

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.

Transcranial Doppler clips database

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Clips of Transcranial Doppler monitoring either MES or non-MES high intensity transient signals (e.g. artifacts, speckle).

You may qualify if:

MES of presumed solid form or non-MES high intensity transient signals

Sponsors & Collaborators

RISE-Heatlh
Type not reportedcollaborator
Sound Vascular Neurology
Type not reportedcollaborator
CRU-RISE

Study Sites (1)

Faculty of Medicine University Porto

Porto, 4200-319, Portugal

Related Publications (10)

Collins GS, Moons KGM, Dhiman P, Riley RD, Beam AL, Van Calster B, Ghassemi M, Liu X, Reitsma JB, van Smeden M, Boulesteix AL, Camaradou JC, Celi LA, Denaxas S, Denniston AK, Glocker B, Golub RM, Harvey H, Heinze G, Hoffman MM, Kengne AP, Lam E, Lee N, Loder EW, Maier-Hein L, Mateen BA, McCradden MD, Oakden-Rayner L, Ordish J, Parnell R, Rose S, Singh K, Wynants L, Logullo P. TRIPOD+AI statement: updated guidance for reporting clinical prediction models that use regression or machine learning methods. BMJ. 2024 Apr 16;385:e078378. doi: 10.1136/bmj-2023-078378.
PMID: 38626948RESULT
Riley RD, Ensor J, Snell KIE, Harrell FE Jr, Martin GP, Reitsma JB, Moons KGM, Collins G, van Smeden M. Calculating the sample size required for developing a clinical prediction model. BMJ. 2020 Mar 18;368:m441. doi: 10.1136/bmj.m441. No abstract available.
PMID: 32188600

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

A Multicenter Study to Optimize Microembolic Signal Classification Based on Double--Blind Multiparametric Assessment by Human Experts Using an Universal Graphical Interface [MESOMEGA]

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Transcranial Doppler clips database

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (10)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Transcranial Doppler clips database

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (10)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations