Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 10:47 AM
Study NCT ID:
NCT02381756
Status:
TERMINATED
Last Update Posted:
2019-03-26
First Post:
2015-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound and Left Ventricular Systolic Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}], 'ancestors': [{'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-25', 'studyFirstSubmitDate': '2015-03-05', 'studyFirstSubmitQcDate': '2015-03-05', 'lastUpdatePostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reproducibility of measurements of the ejection fraction of the left ventricle by two measurement methods and reproducibility of myocardial strain measurements between operators', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'Area under the ROC curve of the value of myocardial strain (GLS)', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dysfunction, Left Ventricular']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ICU patients intubated and ventilated', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICU patients intubated and ventilated\n\nExclusion Criteria:\n\n* Arrhythmia or variability of heart rate\n* Technical impossibility to perform the ultrasound exam\n* Known pregnancy or lactation\n* Non-affiliation to a social security scheme (beneficiary or assignee)\n* Patient under legal protection\n* Patient refusal to participate'}, 'identificationModule': {'nctId': 'NCT02381756', 'acronym': 'EFESE', 'briefTitle': 'Ultrasound and Left Ventricular Systolic Function', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'officialTitle': 'Ultrasound Evaluation of the Left Ventricular Systolic Function in Intensive Care Unit.', 'orgStudyIdInfo': {'id': '2014-A01641-46'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasound', 'type': 'DEVICE', 'description': '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'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Fondation Ophtalmologique Adolphe de Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Nadia Benyounes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Ophtalmologique Adolphe de Rothschild'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}