Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
Study NCT ID:
NCT03776266
Status:
COMPLETED
Last Update Posted:
2019-03-28
First Post:
2018-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Long-term Clinical Outcomes and Patterns of Transfusion in PCI Patients: Retrospective Cohort Study
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': 48786}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-26', 'studyFirstSubmitDate': '2018-12-13', 'studyFirstSubmitQcDate': '2018-12-13', 'lastUpdatePostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence density of transfusion', 'timeFrame': '5 years', 'description': '5-year incidence density of red blood cell transfusion'}], 'secondaryOutcomes': [{'measure': 'Incidence density of MACE', 'timeFrame': '5 years', 'description': '5-year incidence densities of a major adverse clinical event (MACE) consisting of all-cause death, revascularization, critically ill cardiovascular status, and stroke'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transfusion', 'PCI', 'Percutaneous Coronary Intervention'], 'conditions': ['Erythrocyte Transfusion', 'Percutaneous Coronary Intervention', 'Revascularization']}, 'descriptionModule': {'briefSummary': 'A nationwide retrospective cohort study. To investigate the long-term patterns of transfusion and clinical outcomes of patients undergoing PCI.', 'detailedDescription': 'A nationwide retrospective cohort study. Transfusion after PCI may increase a risk, but the long term effects after red blood cell transfusion is known. Longitudinal data is collected from administrative claims in the National Healthcare Insurance Service of Korea. All Korean patient date undergoing PCI inserting stent from January 1, 2011 to December 31, 2011 is extracted. Clinical outcomes until December 31, 2016 is investigated.\n\nPrimary outcome is the incidence density of red blood cell transfusion. Secondary outcomes are the association of transfusion with major adverse clinical event (MACE) consisting all-cause death, revascularization, critically ill cardiovascular status, or stroke.\n\nIncidence density and time-dependent Cox proportional hazard regression is statistically analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing PCI using stent in 2011 from all medical providers in Korea is selected using National Healthcare Insurance System', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All Korean patients undergoing PCI using stent from January 1, 2011 to December 31, 2011\n\nExclusion Criteria:\n\n* Patients without any stent insertion'}, 'identificationModule': {'nctId': 'NCT03776266', 'acronym': 'TFPCI', 'briefTitle': 'The Long-term Clinical Outcomes and Patterns of Transfusion in PCI Patients: Retrospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'The Five-year Pattern of Red Blood Cell Transfusion and Clinical Outcome in Patients Undergoing Percutaneous Coronary Intervention: A Korean Nationwide Longitudinal Cohort Study', 'orgStudyIdInfo': {'id': 'SMC 2018-10-044'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention is required due to retrospective observational study', 'type': 'PROCEDURE', 'otherNames': ['Observation on Red blood cell transfusion on or after percutaneous coronary intervention'], 'description': 'Red blood cell transfusion on or after percutaneous coronary intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'state': 'Gang nam-Gu, Ilwon-Dong', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jin-Ho Choi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Professor', 'investigatorFullName': 'Jin-Ho Choi', 'investigatorAffiliation': 'Samsung Medical Center'}}}}