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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06018090
• Other study ID #: 362/19
• Status: Completed
• Start date: June 6, 2019
• Est. completion date: October 6, 2022

Study information

• Verified date: August 2023
• Source: Centro Hospitalar De São João, E.P.E.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 6, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Brain Infarction
• Embolism
• Infarction
• Infarction, Brain
• Ischemic Stroke

Intervention

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.

Locations

Country	Name	City	State
Portugal	Pedro Miguel Castro	Porto

Sponsors (5)

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

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of MES		Within 24 hours of symptom onset
Primary	Poor functional outcome		90-days after stroke
Secondary	Ordinal Shift Analysis of mRS scale score		90-days after stroke