- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03107637
Transesophageal Echocardiography in Embolic Stroke of Undetermined Source (ETO)
Therapeutic Implications of Early Transesophageal Echocardiography in Embolic Stroke of Undetermined Source (ESUS)
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Paris, France, 75019
- Fondation Ophtalmologique A de Rothschild
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
therapeutic modification after transesophageal echocardiography
Time Frame: 24 hours after TEE
|
proportion of patients with a therapeutic modification (mainly anticoagulation and surgery)
|
24 hours after TEE
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nadia Benyounes, MD, Fondation Ophtalmologique A. de Rothschild
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NBS_2016_12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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