Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-01-29 @ 1:16 PM
Study NCT ID:
NCT02051920
Status:
UNKNOWN
Last Update Posted:
2015-01-12
First Post:
2013-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Elastography Measurement : an Intraoperative Cardiac Surgery Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'lastUpdateSubmitDate': '2015-01-09', 'studyFirstSubmitDate': '2013-10-25', 'studyFirstSubmitQcDate': '2014-01-29', 'lastUpdatePostDateStruct': {'date': '2015-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Young's Modulus measurement according to the equation E = Young 3ρCs ²", 'timeFrame': 'During herat surgery (Day 0)', 'description': "Ultrasound acquisition will be completed in epicardial vue using a linear probe SuperLinear 15-4 ™ connected to an ultrasound (AixplorerTM ® from Supersonic Imagine). The acquisitions will be completed in mode B + Elastrography Shear Wave ™ (SWE). A sterile gel is deposited in the bottom of the pouch of sterile protection of the probe. Many measurements will be done on accessible left and right ventricle areas.\n\nMeasurement of Young's modulus: automated by the onboard model according to the equation E = Young 3ρCs ², where E is the Young's elastic modulus software, ρ is the tissue density and Cs the velocity of shear wave"}], 'secondaryOutcomes': [{'measure': 'diastolic function parameters', 'timeFrame': 'Day 0', 'description': "Correlation between young's modulus and diastolic function parameters is assess after surgery by post processing"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Elastography'], 'conditions': ['Diastolic Dysfunction and Cardiac Stiffness']}, 'descriptionModule': {'briefSummary': 'Since 20 years, the techniques of direct measurement of cardiac stiffness in the diagnosis of myocardial diseases do not exist.\n\nWe propose a human study evaluating the direct measurement of cardiac ultrasound stiffness by elastography.\n\nThis study will include 30 patients with cardiac disease whose rigidity varies with underlying disease.\n\nThe purpose of this study is to evaluate the stiffness during open heart surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients undergoing cardiac surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written consent\n* Patients older than 18 years\n* Every patient scheduled for cardiac surgery\n* Cardiac catheterization within 6 months before surgery,\n* Women of childbearing age in effective contraception (a urine pregnancy test will be performed)\n* Patient affiliated or covered by a plan of health insurance.\n* Francophone\n\nExclusion Criteria:\n\n* Pregnant or lactating woman,\n* Functional walking disability,\n* Patient placed under judicial protection: guardianship,\n* Patient participating in another trial and / or participated in another trial within two months,\n* Patient under guardianship or trusteeship,\n* Women who are not effective contraception,\n* Patient with no liberty by administrative or judicial decision'}, 'identificationModule': {'nctId': 'NCT02051920', 'acronym': 'REA-FO', 'briefTitle': 'Cardiac Elastography Measurement : an Intraoperative Cardiac Surgery Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Measurement of Cardiac Elastography: an Intraoperative Cardiac Surgery Study. Cardiac Elastography in Vivo', 'orgStudyIdInfo': {'id': 'REA-FO-2013-A00593-42'}}, 'contactsLocationsModule': {'locations': [{'zip': '14033', 'city': 'Caen', 'state': 'Basse Normandie', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eric saloux, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'centralContacts': [{'name': 'Eric Saloux, MD', 'role': 'CONTACT', 'email': 'saloux-e@chu-caen.fr', 'phone': '+330231064901'}, {'name': 'Fabrice Bauer, MD,PhD', 'role': 'CONTACT', 'email': 'fabrice.bauer@chu-rouen.fr'}], 'overallOfficials': [{'name': 'Fabrice Bauer, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Rouen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Rouen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}