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Microembolic Detection in Acute Ischemic Stroke Patients With Atrial Fibrillation and Outcome

Microembolic Detection in Acute Ischemic Stroke Patients With Atrial Fibrillation and Outcome - A Prospective Multicenter Study With Transcranial Doppler

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06018090
Enrollment
61
Registered
2023-08-30
Start date
2019-06-06
Completion date
2022-10-06
Last updated
2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Embolism, Infarction, Brain

Keywords

Infarction, Embolism, Atrial Fibrillation, Ultrasound, Transcranial Doppler

Brief summary

This multicenter international prospective cohort study will include patients with AIS with a known or newly diagnosed anticoagulant-naïve AF. All centers will use the same transcranial Doppler machine for one-hour monitoring with bilateral 2-MHz probes within 24 hours of symptom onset. Recordings will be analyzed for MES by a blinded central reader. The primary aim is to determine the proportion of patients with MES and the association of MES with functional outcomes assessed by a modified Rankin scale (mRS) score at 90 days.

Interventions

OTHERThe presence and rate of MES measured by TCD monitoring

TCD monitoring within 24 hours from the last known well time. Bilateral M1 segments of middle cerebral artery were insonated at a single depth with 2-MHz transducers secured by a probe-holder.

Sponsors

University of Giessen
CollaboratorOTHER
University of Padova
CollaboratorOTHER
University of Ostrava
CollaboratorOTHER
Clinical Hospital Centre Zagreb
CollaboratorOTHER
Centro Hospitalar De São João, E.P.E.
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* acute ischemic stroke admitted to the Stroke Unit, history of AF/flutter or a new diagnosis of AF at the stroke, and with a possibility to be monitored within 24 hours after symptom onset.

Exclusion criteria

* use of anticoagulants at stroke onset; prosthetic valves; inadequate temporal bone window; uncooperative patients.

Design outcomes

Primary

MeasureTime frame
Prevalence of MESWithin 24 hours of symptom onset
Poor functional outcome90-days after stroke

Secondary

MeasureTime frame
Ordinal Shift Analysis of mRS scale score90-days after stroke

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026