ClinicalTrials.gg
CompletedNCT06018090Updated Aug 30, 2023

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

An observational study in Infarction, Brain, Embolism and Atrial Fibrillation, sponsored by Centro Hospitalar De São João, E.P.E.. Completed at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-30.

Sponsored by Centro Hospitalar De São João, E.P.E. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
61
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Infarction, Brain
  • Embolism
  • Atrial Fibrillation

Keywords

  • Infarction
  • Embolism
  • Atrial Fibrillation
  • Ultrasound
  • Transcranial Doppler
03

In context

Brain Infarction

93 studies on the registry are indexed under Brain Infarction; 19 are open to participants now.

This study's enrollment of 61 is below the median of 477 across 23 observational studies indexed under Brain Infarction.

Browse Brain Infarction studies →

Lead sponsor

Centro Hospitalar De São João, E.P.E. is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • use of anticoagulants at stroke onset; prosthetic valves; inadequate temporal bone window; uncooperative patients.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
61 participants (actual)
Target follow-up
90 Days
Patient registry
Yes

Groups and cohorts

  • Acute Ischemic Stroke Patients with Atrial Fibrillation

    Other: The presence and rate of MES measured by TCD monitoring

Interventions

  • OtherThe 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.

06

What researchers measure

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

07

Study locations

1 site
  • Pedro Miguel Castro
    Porto, 4200-319, Portugal
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2019 to primary completion in Aug 2022, 38 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2023
First posted
Aug 30, 2023
StartActual
Jun 6, 2019
Primary completionActual
Aug 31, 2022
CompletionActual
Oct 6, 2022
Last update
Aug 30, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06018090
Lead sponsor
Centro Hospitalar De São João, E.P.E.
Collaborators
University of Giessen, University of Padova, University of Ostrava, Clinical Hospital Centre Zagreb
Responsible party
Pedro Castro (Professor, Centro Hospitalar De São João, E.P.E.) — Principal investigator
First posted
Aug 30, 2023
Start date
Jun 6, 2019
Primary completion
Aug 31, 2022
Completion
Oct 6, 2022
Last update
Aug 30, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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