Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-29 @ 9:46 PM
Study NCT ID:
NCT05208957
Status:
COMPLETED
Last Update Posted:
2024-07-16
First Post:
2022-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Outcomes and Mortality in Vascular Surgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-15', 'studyFirstSubmitDate': '2022-01-12', 'studyFirstSubmitQcDate': '2022-01-25', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine in-hospital mortality in elective vascular surgical patients', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Determine incidence of MACE in elective vascular surgical patients.', 'timeFrame': '12 months'}, {'measure': 'Describe the risk factors associated with MACE in elective vascular surgical patients', 'timeFrame': '12 months'}, {'measure': 'Determine incidence of post-operative complications in elective vascular surgical patients', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perioperative Complication', 'Cardiovascular Complication']}, 'descriptionModule': {'briefSummary': 'This is a registry-based study of elective vascular surgical patients undergoing intermediate or high-risk vascular surgical interventions at Groote Schuur hospital, a tertiary academic center, over a 12 month period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population comprises all patients, 18 years and older, undergoing any elective moderate- to high-risk vascular surgical intervention at Groote Schuur Hospital. Surgical risk as defined by ESC/ESA 2014 guidelines.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nAll patients undergoing vascular surgery:\n\n1. 18 years and older\n2. Elective procedures\n3. Moderate- to high-risk surgical interventions\n\nExclusion Criteria:\n\n1. Emergency vascular procedures\n2. Low risk vascular surgery, i.e. venous stripping\n3. All non-vascular surgical interventions'}, 'identificationModule': {'nctId': 'NCT05208957', 'briefTitle': 'Cardiovascular Outcomes and Mortality in Vascular Surgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Cape Town'}, 'officialTitle': 'Cardiovascular Outcomes and Mortality in Vascular Surgical Patients. A Registry-based Study of in Hospital Mortality and Postoperative Complications in Elective Vascular Surgery at Groote Schuur Hospital', 'orgStudyIdInfo': {'id': 'HREC760/2021'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7708', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Groote Schuur Hospital', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}], 'overallOfficials': [{'name': 'Christella Alphonsus, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cape Town'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Not limited', 'ipdSharing': 'YES', 'description': 'Data will be shared by PI', 'accessCriteria': 'Contact PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cape Town', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Principal investigator', 'investigatorFullName': 'Christella Alphonsus', 'investigatorAffiliation': 'University of Cape Town'}}}}