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Completed

NCT Number: NCT06018090

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

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.

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Key information

Conditions

Infarction, Brain Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism Embolism and Thrombosis Heart Diseases Infarction Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pedro Miguel Castro

Porto, 4200-319, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The presence and rate of MES measured by TCD monitoring

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.

Primary outcomes

  1. Prevalence of MES

    Time frame: Within 24 hours of symptom onset

  2. Poor functional outcome

    Time frame: 90-days after stroke

Secondary outcomes

  1. Ordinal Shift Analysis of mRS scale score

    Time frame: 90-days after stroke

Sponsors and collaborators

Lead sponsor

Centro Hospitalar De São João, E.P.E.

Other

Collaborators

  • Clinical Hospital Centre Zagreb
  • University of Giessen
  • University of Ostrava
  • University of Padova

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 30, 2023
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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