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Clinical Trials/NCT06018090
NCT06018090
Completed
Not Applicable

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

Centro Hospitalar De São João, E.P.E.1 site in 1 country61 target enrollmentJune 6, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infarction, Brain
Sponsor
Centro Hospitalar De São João, E.P.E.
Enrollment
61
Locations
1
Primary Endpoint
Prevalence of MES
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 6, 2019
End Date
October 6, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centro Hospitalar De São João, E.P.E.
Responsible Party
Principal Investigator
Principal Investigator

Pedro Castro

Professor

Centro Hospitalar De São João, E.P.E.

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Prevalence of MES

Time Frame: Within 24 hours of symptom onset

Poor functional outcome

Time Frame: 90-days after stroke

Secondary Outcomes

  • Ordinal Shift Analysis of mRS scale score(90-days after stroke)

Study Sites (1)

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