Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 9:39 AM
Study NCT ID:
NCT04778969
Status:
UNKNOWN
Last Update Posted:
2021-03-03
First Post:
2021-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kor PCI - CAD Patients Treated With PCI: Analysis of the Korean Nationwide Health Insurance Database
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054855', 'term': 'Drug-Eluting Stents'}], 'ancestors': [{'id': 'D015607', 'term': 'Stents'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-28', 'studyFirstSubmitDate': '2021-01-13', 'studyFirstSubmitQcDate': '2021-02-28', 'lastUpdatePostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause of death', 'timeFrame': '10 years', 'description': "'All cause of death' will be recorded as number of participants with 'All cause of death'"}], 'secondaryOutcomes': [{'measure': 'Cardiovascular death', 'timeFrame': '10 years', 'description': "'Cardiovascular death' will be recorded as number of participants with 'Cardiovascular death'"}, {'measure': 'ischemic stroke', 'timeFrame': '10 years', 'description': "'ischemic stroke' will be recorded as number of participants with 'ischemic stroke'"}, {'measure': 'Cerebral hemorrhage', 'timeFrame': '10 years', 'description': "'Cerebral hemorrhage' will be recorded as number of participants with 'Cerebral hemorrhage'"}, {'measure': 'Admission due to gastrointestinal bleeding', 'timeFrame': '10 years', 'description': "'Admission due to gastrointestinal bleeding' will be recorded as number of participants with 'Admission due to gastrointestinal bleeding'"}, {'measure': 'Admission due to major bleeding', 'timeFrame': '10 years', 'description': "'Admission due to major bleeding' will be recorded as number of participants with 'Admission due to major bleeding' Thismeasure is a composite outcome, which includes cerebral hemorrhage, admission due to gastrointestinal bleeding."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Drug-eluting Stents', 'Drug-coated Balloon']}, 'descriptionModule': {'briefSummary': 'Current Status and Prognosis of Coronary artery disease patients treated with coronary intervention - Analysis of the Korean Nationwide Health Insurance Database', 'detailedDescription': 'This is a retrospective study and is conducted for all patients who received percutaneous coronary intervention among cohorts registered with the National Health Insurance Service.\n\nPrimary outcome is all cause of mortality. Secondary outcomes are cardiovascular death, ischemic stroke, cerebral hemorrhage, admission due to gastrointestinal bleeding, and admission due to major bleedings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All coronary artery disease patients wih Korean NHIS (National Health Insurance Service)-listed PCI Patients are selected based on the registered treatment insurance code.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All coronary artery disease patients wih Korean NHIS (National Health Insurance Service)-listed PCI\n\nExclusion Criteria:\n\n* non-specified'}, 'identificationModule': {'nctId': 'NCT04778969', 'briefTitle': 'Kor PCI - CAD Patients Treated With PCI: Analysis of the Korean Nationwide Health Insurance Database', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Coronary Artery Disease Patients Treated With Percutaneous Coronary Intervention: Analysis of the Korean Nationwide Health Insurance Database', 'orgStudyIdInfo': {'id': 'E-2009-016-1154'}}, 'armsInterventionsModule': {'interventions': [{'name': 'drug-eluting stent', 'type': 'DEVICE', 'otherNames': ['DES group'], 'description': 'A group of percutaneous coronary intervention (PCI) using drug-eluting stents (DES)'}, {'name': 'drug-coated balloon', 'type': 'DEVICE', 'otherNames': ['DCB group'], 'description': 'A group of percutaneous coronary intervention (PCI) using drug-coated balloon (DCB)'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Han-Mo Yang, MD, PhD', 'role': 'CONTACT', 'email': 'hanname@gmail.com', 'phone': '8220722677'}, {'name': 'Hak Seung Lee, MD', 'role': 'CONTACT', 'email': 'cardiolee@gmail.com', 'phone': '821031668399'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Since this research is conducted with a national public institution, data cannot be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Han-Mo Yang', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}