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Completed

NCT Number: NCT03107637

Transesophageal Echocardiography in Embolic Stroke of Undetermined Source

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.

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Key information

Conditions

Embolic Stroke of Undetermined Source Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation Ophtalmologique A de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

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

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

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

Treatment and study plan

Primary outcomes

  1. therapeutic modification after transesophageal echocardiography

    Time frame: 24 hours after TEE

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

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

Therapeutic Implications of Early Transesophageal Echocardiography in Embolic Stroke of Undetermined Source (ESUS)

Acronym: ETO

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Apr 11, 2017
Registry last updated
Jun 22, 2021

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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