Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT03887767
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2019-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
sST2 and Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-09', 'studyFirstSubmitDate': '2019-03-05', 'studyFirstSubmitQcDate': '2019-03-21', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality rate', 'timeFrame': '1 year', 'description': '1 year mortality rate'}], 'secondaryOutcomes': [{'measure': 'Number of rehospitalisation', 'timeFrame': '1 day', 'description': 'Number of rehospitalisation'}, {'measure': 'Number of cardiac events', 'timeFrame': '1 day', 'description': 'Number of cardiac events'}, {'measure': 'Number of cardiac stroke', 'timeFrame': '1 day', 'description': 'Number of cardiac stroke'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'Evaluation of the prognosis value of sST2 dosed before cardiac surgery on prognosis of long terme prognosis after cardiac surgery.\n\nThe patients where initialy recruted for another cohort named micro-SIRS and inflammation but the gaved their consent to analyse the blood samples for other studies'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients included before cardiac surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 80\n* cardiac surgery includind coronary arterial bypass of valvular surgery\n\nExclusion Criteria:\n\n* other surgery'}, 'identificationModule': {'nctId': 'NCT03887767', 'briefTitle': 'sST2 and Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Prognostic Value of sST2 in Cardiac Surgery on Long Term Morbimortality', 'orgStudyIdInfo': {'id': 'RECHMPL19_0094'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Kada KLOUCHE, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hopital de Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}