Dysfunction, Left VentricularEFESENCT02381756
Ultrasound and Left Ventricular Systolic Function
An observational study of Dysfunction, Left Ventricular, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The aim of this study is to evaluate, in an intensive care unit, the reproducibility between two non-cardiologists operators and a cardiologist expert in echocardiogram, of the Simpson method and of the calculation of GLS for the evaluation of the systolic function of the left ventricle in critically ill patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysfunction, Left Ventricular
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Nov 2015
- 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: ICU patients intubated and ventilated
Who may be able to join
- ICU patients intubated and ventilated
Who cannot join
- Arrhythmia or variability of heart rate
- Technical impossibility to perform the ultrasound exam
- Known pregnancy or lactation
- Non-affiliation to a social security scheme (beneficiary or assignee)
- Patient under legal protection
- Patient refusal to participate
Trial locations and contacts
1 site in 1 country.
France1 site
Fondation Ophtalmologique Adolphe de Rothschild
Paris, Île-de-France Region, 75019
About this study
Official title: Ultrasound Evaluation of the Left Ventricular Systolic Function in Intensive Care Unit.
The aim of this study is to evaluate, in an intensive care unit, the reproducibility between two non-cardiologists operators and a cardiologist expert in echocardiogram, of the Simpson method and of the calculation of GLS for the evaluation of the systolic function of the left ventricle in critically ill patients intubated and ventilated.
- Conditions
- Dysfunction, Left Ventricular
- Being tested
- Ultrasound
- Medical subject headings
- Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Cardiac echocardiography to determin the left ventricular ejection fraction by the biplane modified Simpson rule and by the calculation of the Strain Longitudinal Global by 2-D speckle tracking strain echocardiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility of measurements of the ejection fraction of the left ventricle by two measurement methods and reproducibility of myocardial strain measurements between operators
Measured: Baseline
Secondary outcomes (1)
Area under the ROC curve of the value of myocardial strain (GLS)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunction, Left VentricularStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
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 Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381756
- Sponsor's protocol ID
- 2014-A01641-46
- Acronym
- EFESE
- Status last verified
- Mar 2019
- First submitted
- 5 Mar 2015
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluation of the Left Ventricular Systolic Function in Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT02381756
- Acronym / sponsor ID
- EFESE / 2014-A01641-46
- Conditions
- Dysfunction, Left Ventricular
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Nov 2015 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 6 Mar 2015 (estimated)
- 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 aim of this study is to evaluate, in an intensive care unit, the reproducibility between two non-cardiologists operators and a cardiologist expert in echocardiogram, of the Simpson method and of the calculation of GLS for the evaluation of the systolic function of the left ventricle in critically ill patients intubated and ventilated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients intubated and ventilated
Key inclusion criteria (1 listed)
- ICU patients intubated and ventilated
Key exclusion criteria (6 listed)
- Arrhythmia or variability of heart rate
- Technical impossibility to perform the ultrasound exam
- Known pregnancy or lactation
- Non-affiliation to a social security scheme (beneficiary or assignee)
- Patient 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundCardiac echocardiography to determin the left ventricular ejection fraction by the biplane modified Simpson rule and by the calculation of the Strain Longitudinal Global by 2-D speckle tracking strain echocardiography | Device | – |
Primary outcome
Reproducibility of measurements of the ejection fraction of the left ventricle by two measurement methods and reproducibility of myocardial strain measurements between operators
Time frame: Baseline
1 secondary outcome
Area under the ROC curve of the value of myocardial strain (GLS)
Time frame: Baseline
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
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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 Adolphe 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 Dysfunction, Left Ventricular, 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 1 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: stopped early, as of the sponsor's last update on 26 Mar 2019. 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 was stopped early. Results are not available in the source record.
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?
Reproducibility of measurements of the ejection fraction of the left ventricle by two measurement methods and reproducibility of myocardial strain measurements between operators (time frame: Baseline). 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 26 Mar 2019.