Microembolic Detection in Acute Ischemic Stroke Patients With Atrial Fibrillation and Outcome
1 other identifier
observational
61
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2022
CompletedFirst Submitted
Initial submission to the registry
August 25, 2023
CompletedFirst Posted
Study publicly available on registry
August 30, 2023
CompletedAugust 30, 2023
August 1, 2023
3.2 years
August 25, 2023
August 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Prevalence of MES
Within 24 hours of symptom onset
Poor functional outcome
90-days after stroke
Secondary Outcomes (1)
Ordinal Shift Analysis of mRS scale score
90-days after stroke
Study Arms (1)
Acute Ischemic Stroke Patients with Atrial Fibrillation
Interventions
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.
Eligibility Criteria
Acute ischemic stroke admitted to the Stroke Unit, history of AF/flutter, or a new diagnosis of AF at the time of stroke, and able possibility to be monitored within 24 hours after symptom onset.
You may qualify if:
- 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.
You may not qualify if:
- use of anticoagulants at stroke onset; prosthetic valves; inadequate temporal bone window; uncooperative patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centro Hospitalar De São João, E.P.E.lead
- University of Giessencollaborator
- University of Padovacollaborator
- University of Ostravacollaborator
- Clinical Hospital Centre Zagrebcollaborator
Study Sites (1)
Pedro Miguel Castro
Porto, 4200-319, Portugal
Related Publications (1)
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.
PMID: 38149620DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 90 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 25, 2023
First Posted
August 30, 2023
Study Start
June 6, 2019
Primary Completion
August 31, 2022
Study Completion
October 6, 2022
Last Updated
August 30, 2023
Record last verified: 2023-08