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

Sponsor

Centro Hospitalar De São João, E.P.E. (Other)

Overall Status

Completed

CT.gov ID

NCT06018090

Collaborator

University of Giessen (Other), University of Padova (Other), University of Ostrava (Other), Clinical Hospital Centre Zagreb (Other)

Enrollment

Location

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infarction, Brain Embolism Atrial Fibrillation	Other: The presence and rate of MES measured by TCD monitoring

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

61 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 6, 2019

Actual Primary Completion Date :

Aug 31, 2022

Actual Study Completion Date :

Oct 6, 2022

Arms and Interventions

Arm	Intervention/Treatment
Acute Ischemic Stroke Patients with Atrial Fibrillation	Other: 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.

Arm

Intervention/Treatment

Acute Ischemic Stroke Patients with Atrial Fibrillation

Other: 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.

Outcome Measures

Primary Outcome Measures

Prevalence of MES [Within 24 hours of symptom onset]
Poor functional outcome [90-days after stroke]

Secondary Outcome Measures

Ordinal Shift Analysis of mRS scale score [90-days after stroke]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.