Transesophageal Echocardiography in Embolic Stroke of Undetermined Source

Ischemic Stroke Clinical Trial

— ETO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03107637
• Other study ID #: NBS_2016_12
• Status: Completed
• Start date: October 3, 2016
• Est. completion date: January 2019

Study information

• Verified date: June 2021
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: January 2019
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolic Stroke of Undetermined Source
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
France	Fondation Ophtalmologique A de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	therapeutic modification after transesophageal echocardiography	proportion of patients with a therapeutic modification (mainly anticoagulation and surgery)	24 hours after TEE