Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-01-07 @ 4:19 AM
Study NCT ID:
NCT04408404
Status:
COMPLETED
Last Update Posted:
2020-05-29
First Post:
2020-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Influencing Perioperative Mortality in Type A Acute Aortic Dissections Operated at Dijon University Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000784', 'term': 'Aortic Dissection'}], 'ancestors': [{'id': 'D000094665', 'term': 'Dissection, Blood Vessel'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000094683', 'term': 'Acute Aortic Syndrome'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-28', 'studyFirstSubmitDate': '2020-05-26', 'studyFirstSubmitQcDate': '2020-05-28', 'lastUpdatePostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Monitor peri-operative mortality incidence rates', 'timeFrame': '1 day', 'description': 'Mortality during peri-operative acute aortic dissection procedure'}], 'secondaryOutcomes': [{'measure': 'Monitor peri-operative morbidity incidence rates', 'timeFrame': '1 day', 'description': 'Stroke, Kidney failure, Reexploration for bleeding'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Dissection']}, 'descriptionModule': {'briefSummary': 'Type A acute aortic dissections are a rare condition whose natural evolution is catastrophic. Global mortality remains high even if it decreased last years. This is probably due to improvement of diagnostic techniques and the evolution of surgical practices. It is however important to have medical data and statistics obtained in past years in order to better understand the factors influencing peroperative mortality and thereby to continue this improvement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent aortic dissection surgery in Dijon Burgundy University Hospital since the 01 January 2007 and the 31 december 2017.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who underwent aortic dissection surgery in Dijon Burgundy University Hospital\n\nExclusion Criteria:\n\n* patients who died before the surgical incision'}, 'identificationModule': {'nctId': 'NCT04408404', 'briefTitle': 'Factors Influencing Perioperative Mortality in Type A Acute Aortic Dissections Operated at Dijon University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier La Chartreuse'}, 'officialTitle': 'Factors Influencing Perioperative Mortality in Type A Acute Aortic Dissections Operated at Dijon University Hospital', 'orgStudyIdInfo': {'id': 'CCVT- Dissection'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type A aortic dissection', 'description': 'Patient operated for type A acute aortic dissection between 01 January 2007 and 31 December 2017 in Dijon Burgundy University Hospital', 'interventionNames': ['Procedure: Acute aortic dissection']}], 'interventions': [{'name': 'Acute aortic dissection', 'type': 'PROCEDURE', 'description': 'Acute aortic dissection treatment include Bentall procedure, Tyrone David procedure, Yacoub procedure or ascendant aortic replacement with or without aortic valve replacement, ascendant aortic root remodelling (all are standard of care procedures)', 'armGroupLabels': ['Type A aortic dissection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Cardiovascular and thoracic surgery Unit - Dijon University Hopital', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All patients are informed before surgery that all the medical data included in the medical record could be used in cardiovascular monocentric retrospective study. No data shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier La Chartreuse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'MORGANT Marie-Catherine', 'investigatorAffiliation': 'Centre Hospitalier La Chartreuse'}}}}