Embolic Stroke of Undetermined SourceETONCT03107637
Transesophageal Echocardiography in Embolic Stroke of Undetermined Source
An observational study of Embolic Stroke of Undetermined Source and Ischemic Stroke, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Embolic Stroke of Undetermined Source, Ischemic Stroke
- How many people
- 186 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2016to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed for ichemic stroke meeting embolic source of unknown source criteria
Who may be able to join
- Presenting with a new onset of ischemic stroke
- Meeting the ESUS criteria (Embolic Stroke of Undetermined Source)
- Comprehensive transthoracic echo prior to the TEE
Who cannot join
- ESUS criteria not met
- Contraindications to TEE
- TEE failure
- Pregnant or breastfeeding woman
- Person under legal protection
- No medical insurance coverage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Keywords
- Embolic Stroke of Undetermined Source, transesophageal echocardiography, cardiac source of embolism, ischemic stroke
- Medical subject headings
- Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
therapeutic modification after transesophageal echocardiography
proportion of patients with a therapeutic modification (mainly anticoagulation and surgery)
Measured: 24 hours after TEE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start3 Oct 2016
- Primary completionApr 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embolic Stroke of Undetermined SourceStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Nadia Benyounes, MD, Principal investigator, Fondation Ophtalmologique A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107637
- Sponsor's protocol ID
- NBS_2016_12
- Acronym
- ETO
- Status last verified
- Jun 2021
- First submitted
- 5 Apr 2017
- Last updated
- 22 Jun 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Implications of Early Transesophageal Echocardiography in Embolic Stroke of Undetermined Source (ESUS)
- ClinicalTrials.gov ID
- NCT03107637
- Acronym / sponsor ID
- ETO / NBS_2016_12
- Keywords
- Embolic Stroke of Undetermined Source, transesophageal echocardiography, cardiac source of embolism, ischemic stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed for ichemic stroke meeting embolic source of unknown source criteria
Key inclusion criteria (3 listed)
- Presenting with a new onset of ischemic stroke
- Meeting the ESUS criteria (Embolic Stroke of Undetermined Source)
- Comprehensive transthoracic echo prior to the TEE
Key exclusion criteria (6 listed)
- ESUS criteria not met
- Contraindications to TEE
- TEE failure
- Pregnant or breastfeeding woman
- Person under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
therapeutic modification after transesophageal echocardiography
Time frame: 24 hours after TEE
proportion of patients with a therapeutic modification (mainly anticoagulation and surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
Related trials for Embolic Stroke of Undetermined Source
Active, not recruitingObservational study
Paroxysmal Nocturnal Hemoglobinuria in ESUS & ETUS
Paroxysmal Nocturnal Hemoglobinuria, Embolic Stroke of Undetermined Source
RecruitingObservational study
SENIOR: Stroke Prevention in the Elderly by Patent Foramen Ovale closuRe vs Anticoagulation
Ischemic Stroke, Embolic Stroke of Undetermined Source
RecruitingObservational study
High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From symptomaTic Non-stenotic cARotid Disease (SyNC)
Carotid Artery Disease, Symptomatic Carotid Artery Stenosis
Recruiting
Atrial Fibrillation Detection Using MEMO Patch in Patients With Stroke of Unknown Cause
Embolic Stroke of Undetermined Source
RecruitingObservational study
AI-Based Prediction of Atrial Fibrillation in ESUS Patients With ICM
Embolic Stroke of Undetermined Source
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia Benyounes, MD principal investigator
Fondation Ophtalmologique A. de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Embolic Stroke of Undetermined Source and Ischemic Stroke, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
therapeutic modification after transesophageal echocardiography (time frame: 24 hours after TEE). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.