Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-30 @ 9:09 PM
Study NCT ID:
NCT04641169
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2020-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concordance AUTOFEVG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2020-07-13', 'studyFirstSubmitQcDate': '2020-11-20', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluate the interobserver reproducibility', 'timeFrame': 'Day 0', 'description': 'evaluate the interobserver reproducibility of the automatic measurement of LVEF with a pocket ultrasound device'}], 'secondaryOutcomes': [{'measure': 'Assess the interobserver reproducibility of visual LVEF', 'timeFrame': 'day 0', 'description': 'Assess the interobserver reproducibility of visual LVEF'}, {'measure': 'Interobserver reproducibility of the visual LVEF measurement;', 'timeFrame': 'Day 0', 'description': 'Assess the interobserver reproducibility of the visual LVEF measurement;'}, {'measure': 'Evaluate the intraobserver reproducibility of the automatic LVEF measurement', 'timeFrame': 'Day 0', 'description': 'Evaluate the intraobserver reproducibility of the automatic LVEF measurement'}, {'measure': 'Ability of the pocket ultrasound scanner to give an ultrasound image useable by the doctor performing the examination.', 'timeFrame': 'Day 0', 'description': 'feasibility of each method (visual and automatic) to obtain an ultrasound image useable'}, {'measure': 'Ability of the pocket ultrasound scanner to give an ultrasound image useable by the doctor performing the examination considering image quality', 'timeFrame': 'Day 0', 'description': 'Quality of image obtained by each méthod (Visual and Automatic)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Echocardiography', 'Medicine, Emergency', 'Technology Assessment, Biomedical', 'Heart Diseases']}, 'referencesModule': {'references': [{'pmid': '39133705', 'type': 'RESULT', 'citation': 'Berger L, Coisy F, Sammoud S, de Oliveira F, Grandpierre RG, Grau-Mercier L, Bobbia X, Markarian T. Evaluation of left ventricular ejection fraction by a new automatic tool on a pocket ultrasound device: Concordance study with cardiac magnetic resonance imaging. PLoS One. 2024 Aug 12;19(8):e0308580. doi: 10.1371/journal.pone.0308580. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'Clinical ultrasound has become essential in emergency medicine. The guidelines are to use of echocardiography in specific contexts: dyspnea, hypotension or chest pain. The evaluation of left ventricle ejection fraction (LVEF) is one of the basic objectives of echocardiography. The reference assessment in emergency medicine is visual assessment. It suffers from poor inter-observer reproducibility. Pocket ultrasound scanners seem to meet the constraints of point-of-care ultrasound. A new tool is available on a pocket ultrasound device: the automatic evaluation of LVEF. Its interest could be to have a better inter-observer reproducibility than visual evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patient over 18 years of age\n* Management in the investigator centre\n* Admitted for dyspnea or hypotension or chest pain\n\nExclusion criteria:\n\n* Age \\< 18 years\n* Patient not benefiting from a social security system\n* Patient deprived of liberty\n* Patient under the protection of justice, under guardianship or curatorship\n* Patient refusing to participate in the study\n* Inability to provide the patient with informed information'}, 'identificationModule': {'nctId': 'NCT04641169', 'acronym': 'CONCORDANCEVEF', 'briefTitle': 'Concordance AUTOFEVG', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Evaluation of the Ejection Fraction of the Left Ventricle Ejection Fraction (LVEF) by a New Automatic Evaluation Tool in a Pocket Ultrasound Device: Study of Concordance With the Estimated by Cardiac Magnetic Reasoning Imaging (MRI)', 'orgStudyIdInfo': {'id': 'LOCAL/2020/XB-01'}, 'secondaryIdInfos': [{'id': '2020-A01422-37', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Echocardiography', 'description': '• Echocardiography performed by the evaluator 1: 2 LVEF visual evaluations 2 LVEF automatic evaluations\n\n• Echocardiography performed by the evaluator 2: 2 LVEF visual evaluations 2 LVEF automatic evaluations', 'interventionNames': ['Procedure: echocardiography']}], 'interventions': [{'name': 'echocardiography', 'type': 'PROCEDURE', 'description': 'Four measurements in echocardiography performed in addition to standard care', 'armGroupLabels': ['Echocardiography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHRU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Xavier Bobbia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}