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CompletedNCT03107637ETOUpdated Jun 22, 2021

Transesophageal Echocardiography in Embolic Stroke of Undetermined Source

An observational study in Embolic Stroke of Undetermined Source and Ischemic Stroke, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-22.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
186
Ages
18 Years and older
Sex
All
01

Study summary

The ESUS concept was introduced recently to describe a non-lacunar stroke of undetermined etiology. The following etiological workup is required in this setting: head CT or MRI, 12-lead ECG, transthoracic echocardiography, continuous cardiac monitoring for at least 24 hours after stroke, vascular imaging (ultrasound, magnetic resonance angiography, CT angiography, catheter angiography). Transesophageal echocardiography (TEE) is considered not to be required.

However, aortic arch atheroma as diagnosed by TEE in the setting of recent ischemic stroke is a major aortic source of embolism, as supported by numerous well conducted studies. The European Association of Echocardiography considers that TEE is the gold standard for the diagnosis and the characterization of aortic atheroma. It is also the method of choice for the diagnosis of infectious endocarditis.

The aim of this work was to evaluate the rate of patients with a therapeutic modification induced by TEE (mainly anticoagulation and surgery), in consecutive patients admitted with ESUS at our institution stroke unit.

02

Conditions studied

  • Embolic Stroke of Undetermined Source
  • Ischemic Stroke

Keywords

  • Embolic Stroke of Undetermined Source
  • transesophageal echocardiography
  • cardiac source of embolism
  • ischemic stroke
03

Who can participate

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

Study population

Patients followed for ichemic stroke meeting embolic source of unknown source criteria

Inclusion criteria

  • Presenting with a new onset of ischemic stroke
  • Meeting the ESUS criteria (Embolic Stroke of Undetermined Source)
  • Comprehensive transthoracic echo prior to the TEE

Exclusion criteria

Exclusion Criteria:

  • ESUS criteria not met
  • Contraindications to TEE
  • TEE failure
  • Pregnant or breastfeeding woman
  • Person under legal protection
  • No medical insurance coverage
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
186 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. therapeutic modification after transesophageal echocardiography

    proportion of patients with a therapeutic modification (mainly anticoagulation and surgery)

    Time frame: 24 hours after TEE

06

Study locations

1 site
  • Fondation Ophtalmologique A de Rothschild
    Paris, 75019, France
07

Registry details

Key details

Study ID
NCT03107637
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Responsible party
Sponsor
First posted
Apr 11, 2017
Start date
Oct 3, 2016
Primary completion
Apr 2018
Completion
Jan 2019
Last update
Jun 22, 2021

Study contacts

Nadia Benyounes, MD
principal investigator · Fondation Ophtalmologique A. de Rothschild
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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