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Transesophageal Echocardiography in Embolic Stroke of Undetermined Source (ETO)

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ClinicalTrials.gov Identifier: NCT03107637
Recruitment Status : Active, not recruiting
First Posted : April 11, 2017
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief 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.


Condition or disease
Embolic Stroke of Undetermined Source Ischemic Stroke

Study Type : Observational
Actual Enrollment : 186 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Therapeutic Implications of Early Transesophageal Echocardiography in Embolic Stroke of Undetermined Source (ESUS)
Actual Study Start Date : October 3, 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019



Primary Outcome Measures :
  1. therapeutic modification after transesophageal echocardiography [ Time Frame: 24 hours after TEE ]
    proportion of patients with a therapeutic modification (mainly anticoagulation and surgery)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients followed for ichemic stroke meeting embolic source of unknown source criteria
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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107637


Locations
France
Fondation Ophtalmologique A de Rothschild
Paris, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
Principal Investigator: Nadia Benyounes, MD Fondation Ophtalmologique A. de Rothschild

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03107637     History of Changes
Other Study ID Numbers: NBS_2016_12
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Embolic Stroke of Undetermined Source
transesophageal echocardiography
cardiac source of embolism
ischemic stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases