Transesophageal Echocardiography in Embolic Stroke of Undetermined Source

NCT ID: NCT03107637

Last Updated: 2021-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

186 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-03

Study Completion Date

2019-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Embolic Stroke of Undetermined Source Ischemic Stroke

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nadia Benyounes, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Ophtalmologique A. de Rothschild

Locations

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Fondation Ophtalmologique A de Rothschild

Paris, , France

Site Status

Countries

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France

Other Identifiers

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NBS_2016_12

Identifier Type: -

Identifier Source: org_study_id

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