Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT05833256
Status:
UNKNOWN
Last Update Posted:
2023-04-27
First Post:
2023-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prediction Model for 1-year Mortality After Valvular Heart Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2046}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-26', 'studyFirstSubmitDate': '2023-02-28', 'studyFirstSubmitQcDate': '2023-04-26', 'lastUpdatePostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1-year mortality after valvular heart surgery', 'timeFrame': '1 year after valvular heart surgery', 'description': 'Mortality at follow-up was analysed using time-to-event analysis, with survival time defined as the time from date of surgery until date of death.'}], 'secondaryOutcomes': [{'measure': 'neutrophil-to-lymphocyte ratio (NLR), calculated as the number of neutrophils divided by the number of lymphocytes', 'timeFrame': 'within 1 month before surgery', 'description': 'the white blood cell count with (neutrophil)'}, {'measure': 'monocyte-to-lymphocyte ratio (MLR), calculated as the number of monocytes divided by the number of lymphocytes', 'timeFrame': 'within 1 month before surgery', 'description': 'the white blood cell count with ( monocyte)'}, {'measure': 'platelet-to-lymphocyte ratio (PLR), calculated as the number of platelets divided by the number of lymphocytes', 'timeFrame': 'within 1 month before surgery', 'description': 'the white blood cell count with platelet'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patients Undergoing Valvular Heart Surgery']}, 'descriptionModule': {'briefSummary': 'The investigators aimed to develop a predictive model for mortality incorporating nutritional, inflammatory, and perioperative factors in patients undergoing valvular heart surgery. In this retrospective study, the investigators aimed to establish a comprehensive prediction model to predict the risk of 1-year mortality in valvular heart surgery patients through the identification of the inflammatory index most associated with 1-year mortality and developing a prognostic nomogram model incorporating perioperative risk factors with nutritional and inflammatory indices that would be verified by validation cohorts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Tertiary care hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\) patients who presented for surgery primarily due to valvular heart disease, including those who required concomitant coronary artery bypass surgery, aortic procedures, or other cardiac procedures.\n\nExclusion Criteria:\n\n1. patients aged \\<18 years\n2. undergoing transcatheter valve replacement, combined congenital heart surgery, or implantation of ventricular assist device, 3) lacking data required for calculating inflammatory indices, or 4) follow-up loss.'}, 'identificationModule': {'nctId': 'NCT05833256', 'briefTitle': 'A Prediction Model for 1-year Mortality After Valvular Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Inflammation-related Markers for the Prediction of Postoperative 1-year Mortality in Patients Undergoing Valvular Heart Surgery', 'orgStudyIdInfo': {'id': '4-2022-1117'}}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jin Sun Cho', 'role': 'CONTACT', 'email': 'chjs0214@yuhs.ac', 'phone': '82-2-2228-2419'}], 'facility': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jin Sun Cho', 'role': 'CONTACT', 'email': 'chjs0214@yuhs.ac', 'phone': '82-2-2228-2419'}], 'overallOfficials': [{'name': 'Jin Sun Cho', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}