Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-05-29 @ 12:01 PM
Study NCT ID:
NCT03298932
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2016-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
2D Strain of Right Ventricle in Peroperative of Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-27', 'studyFirstSubmitDate': '2016-10-11', 'studyFirstSubmitQcDate': '2017-09-26', 'lastUpdatePostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2D strain modification of right ventricle after cardiac surgery', 'timeFrame': 'up to 24 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Transesophageal echography', 'Perioperative cardiac surgery', 'Aortic valve replacement', '2D strain of right ventricle'], 'conditions': ['Aortic Valve Disorder']}, 'descriptionModule': {'briefSummary': 'Evaluation of the right ventricle (RV) deformation (strain) with 2D speckle tracking technics obtained by echocardiographies (TEE) in peroperative period of cardiac surgery .\n\nTEE is performed for each patient of cardiac surgery during the operation time .\n\nThis new evaluation parameter of RV could be a good tool to assess the early RV dysfunction after cardiac surgery.', 'detailedDescription': 'Monitoring of 2D strain of right ventricle free wall by TEE in perioperative of cardiac surgery :\n\nIn preoperative time After sternotomy After surgery Inclusions of patients elected for aortic valve surgery without coronary diseases or previous RV dysfunction.\n\nComparison with others echocardiographic parameters of RV evaluation Association with right ventricle insufficiency after cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient eligible for aortic valve surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient eligible for aortic valve surgery\n\nExclusion criteria:\n\n* previous right ventricle dysfunction\n* severe coronary disease'}, 'identificationModule': {'nctId': 'NCT03298932', 'briefTitle': '2D Strain of Right Ventricle in Peroperative of Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': '2D Strain of Right Ventricle in Peroperative Cardiac Surgery : Evaluation of Early Signs of RV Dysfunction', 'orgStudyIdInfo': {'id': '9597'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Aortic valve surgery', 'type': 'PROCEDURE', 'description': 'Aortic valve surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hôpital Arnaud de Villeneuve réanimation', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Géraldine CULAS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}