Transesophageal Echocardiography in Embolic Stroke of Undetermined Source

NCT03107637 | Completed

• 1 other identifier: NBS_2016_12
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Embolic Stroke of Undetermined Source; Ischemic Stroke

Keywords

Embolic Stroke of Undetermined Source; transesophageal echocardiography; cardiac source of embolism; ischemic stroke

Outcome Measures

Primary Outcomes (1)

• therapeutic modification after transesophageal echocardiography

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

  24 hours after TEE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients followed for ichemic stroke meeting embolic source of unknown source criteria

You may qualify if:

• Presenting with a new onset of ischemic stroke
• Meeting the ESUS criteria (Embolic Stroke of Undetermined Source)
• Comprehensive transthoracic echo prior to the TEE

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique A de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nadia Benyounes, MD

  Fondation Ophtalmologique A. de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 11, 2017
• Study Start: October 3, 2016
• Primary Completion: April 1, 2018
• Study Completion: January 1, 2019
• Last Updated: June 22, 2021

Record last verified: 2021-06

Locations

FR (1)