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

NCT ID: NCT06018090

Last Updated: 2023-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-06

Study Completion Date

2022-10-06

Brief Summary

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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.

Detailed Description

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Conditions

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Infarction, Brain Embolism Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute Ischemic Stroke Patients with Atrial Fibrillation

The presence and rate of MES measured by TCD monitoring

Intervention Type OTHER

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.

Interventions

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The 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Giessen

OTHER

Sponsor Role collaborator

University of Padova

OTHER

Sponsor Role collaborator

University of Ostrava

OTHER

Sponsor Role collaborator

Clinical Hospital Centre Zagreb

OTHER

Sponsor Role collaborator

Centro Hospitalar De São João, E.P.E.

OTHER

Sponsor Role lead

Responsible Party

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Pedro Castro

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pedro Miguel Castro

Porto, , Portugal

Site Status

Countries

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Portugal

References

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Castro P, Ferreira J, Malojcic B, Bazadona D, Baracchini C, Pieroni A, Skoloudik D, Azevedo E, Kaps M. Detection of microemboli in patients with acute ischaemic stroke and atrial fibrillation suggests poor functional outcome. Eur Stroke J. 2024 Jun;9(2):409-417. doi: 10.1177/23969873231220508. Epub 2023 Dec 27.

Reference Type DERIVED
PMID: 38149620 (View on PubMed)

Other Identifiers

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362/19

Identifier Type: -

Identifier Source: org_study_id

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