Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-02 @ 6:15 AM
Study NCT ID:
NCT04833751
Status:
RECRUITING
Last Update Posted:
2024-07-24
First Post:
2021-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of Cardio/Neurovascular Anesthesia Including the Database of Biological Signals During Anesthesia, Preoperative Assessment and Prognosis in Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-22', 'studyFirstSubmitDate': '2021-04-01', 'studyFirstSubmitQcDate': '2021-04-05', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all cause mortality', 'timeFrame': 'one year after surgery', 'description': 'All-cause mortality within one year after surgery'}], 'secondaryOutcomes': [{'measure': 'Postprocedural myocardial infarction', 'timeFrame': 'within 2days after surgery', 'description': 'Defined by an increase in CK-MB or cardiac troponin (cTn) levels.'}, {'measure': 'Acute kidney injury', 'timeFrame': 'within 7days after surgery', 'description': "The definition of AKI refers to the Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group's KDIGO Clinical Practice Guideline for Acute Kidney Injury."}, {'measure': 'surgical re-exploration', 'timeFrame': 'within 30 days (±3 days) after surgery', 'description': 'require a return to the operating room for bleeding with or without tamponade, graft occlusion, valve dysfunction, or other cardiac reason'}, {'measure': 'deep sternal wound infection', 'timeFrame': 'within 30 days (±3 days) after surgery', 'description': 'infection involving muscle, bone, or mediastinum requiring operative intervention'}, {'measure': 'prolonged mechanical ventilation', 'timeFrame': 'within 30 days (±3 days) after surgery', 'description': 'intubation required for more than 24 hours'}, {'measure': 'stroke/cerebrovascular accident', 'timeFrame': 'within 30 days (±3 days) after surgery', 'description': 'Confirmed neurological deficit caused by a blood supply disturbance to the brain lasting more than 24 hours'}, {'measure': 'Readmission rate', 'timeFrame': 'within 30days of the date of discharge from the index cardiac surgery hospitalization', 'description': 'readmission to an acute care hospital within 30 days of discharge from the cardiac surgery hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac Diseases', 'Biosignal data', 'Cardiac Surgical Procedures', 'Cardiovascular Surgical Procedures', 'Heart Valve Prosthesis Implantation'], 'conditions': ['Cardiac Anaesthesia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish a registry database for patients undergoing anesthesia for cardiovascular surgery or procedures in our operating or hybrid room. The following information will be collected:\n\n1. Preoperative patient assessment\n2. All monitored perioperative biosignal data\n3. Intraoperative and immediate postoperative hemodynamic information, input/output balance, and medication usage\n4. Short- and long-term prognosis from electronic medical records This database will be used to develop a vigilant monitoring system that integrates multiple biosignal data simultaneously, contributing to the improvement of anesthesia care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing cardio/neurovascular surgery or procedure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults age 19 and older\n2. Patients scheduled for anesthesia at a cardiovascular hospital for cardiovascular surgery or procedures\n\nExclusion Criteria:\n\n1\\) Emergency (surgery/procedure room transfer within 1 hour of visit) where there is insufficient time for the subject (adult 19 years of age or older) or his/her representative (adult incapable of consent) to decide whether to participate in the study'}, 'identificationModule': {'nctId': 'NCT04833751', 'briefTitle': 'Registry of Cardio/Neurovascular Anesthesia Including the Database of Biological Signals During Anesthesia, Preoperative Assessment and Prognosis in Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Registry of Cardiovascular Anesthesia Including the Database of Biological Signals During Anesthesia, Preoperative Assessment and Prognosis in Patients: Severance Cardiovascular Surgery Prospective (SECURE) Database', 'orgStudyIdInfo': {'id': '4-2018-1002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anesthesia for cardiovascular surgery or procedure', 'description': 'Patients undergoing anesthesia in an operating room or hybrid room for cardiovascular surgery or procedure.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sarah Soh, MD. PhD', 'role': 'CONTACT'}], 'facility': 'Yonsei University Health System, Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sarah Soh, MD, PhD', 'role': 'CONTACT', 'email': 'yeonchoo@yuhs.ac', 'phone': '82-2-2228-8512'}], 'overallOfficials': [{'name': 'Sarah Soh, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.\n\nStart and end dates: Beginning 6 months and ending 36 months following article publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}