Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-30 @ 9:58 PM
Study NCT ID:
NCT05624905
Status:
RECRUITING
Last Update Posted:
2024-08-14
First Post:
2022-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Pecutaneous Coronary Intervention Registry
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': 'D062645', 'term': 'Percutaneous Coronary Intervention'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2022-11-15', 'studyFirstSubmitQcDate': '2022-11-15', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of Cardiac death or Target-vessel myocardial infarction', 'timeFrame': 'up to 10 years', 'description': 'A composite of cardiac death or target vessel myocardial infarction'}, {'measure': 'Rates of Major adverse cardiac and cerebrovascular event', 'timeFrame': 'up to 10 years', 'description': 'A composite of all-cause death, myocardial infarction, cerebrovascular accident, or repeat revascularization'}], 'secondaryOutcomes': [{'measure': 'Rates of all-cause death', 'timeFrame': 'up to 10 years', 'description': 'Death from any cause'}, {'measure': 'Rates of cardiac death', 'timeFrame': 'up to 10 years', 'description': 'Death from cardiac cause'}, {'measure': 'Rates of myocardial infarction', 'timeFrame': 'up to 10 years', 'description': 'Any myocardial infarction'}, {'measure': 'Rates of target-vessel myocardial infarction', 'timeFrame': 'up to 10 years', 'description': 'target-vessel myocardial infarction'}, {'measure': 'Rates of target lesion revascularization', 'timeFrame': 'up to 10 years', 'description': 'target lesion revascularization'}, {'measure': 'Rates of target vessel revascularization', 'timeFrame': 'up to 10 years', 'description': 'target vessel revascularization'}, {'measure': 'Rates of cerebrovascular accident', 'timeFrame': 'up to 10 years', 'description': 'ischemic or hemorrhagic stroke'}, {'measure': 'Rates of stent thrombosis', 'timeFrame': 'up to 10 years', 'description': 'definite or probable stent thrombosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Percutaneous Coronary Intervention']}, 'referencesModule': {'references': [{'pmid': '37495350', 'type': 'DERIVED', 'citation': 'Choi KH, Lee SY, Song YB, Park TK, Lee JM, Yang JH, Choi JH, Choi SH, Gwon HC, Hahn JY. Prognostic Impact of Operator Experience and IVUS Guidance on Long-Term Clinical Outcomes After Complex PCI. JACC Cardiovasc Interv. 2023 Jul 24;16(14):1746-1758. doi: 10.1016/j.jcin.2023.04.022.'}]}, 'descriptionModule': {'briefSummary': 'Coronary artery disease is the most important cause of death worldwide. Treatment option for coronary artery disease is medical treatment, percutaneous coronary intervention, or coronary artery bypass surgery. Among them, the field of percutaneous coronary intervention is rapidly developing with regard to the improvement of devices, techniques, or medical treatment, leading to reduce mortality or morbidity. Until now, numerous previous studies related to the risk factors of coronary artery disease and the prognosis of patients have been conducted. However, the field of percutaneous coronary intervention is rapidly evolving, and treatment strategies are constantly being updated. Therefore, the current study sought to identify the long-term prognosis and related risk factors of patients with coronary artery disease who underwent percutaneous coronary intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients who underwent coronary angiography adn percutaneous coronary intervention', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who have undergone or are scheduled to undergo coronary angiography and percutaneous coronary intervention.\n\nExclusion Criteria:\n\n* patients who did not consent to the research'}, 'identificationModule': {'nctId': 'NCT05624905', 'acronym': 'SMC-PCI', 'briefTitle': 'Prospective Pecutaneous Coronary Intervention Registry', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Prospective Registry for Identifying Long-term Prognosis in Patients Who Underwent Coronary Angiography and Percutaneous Coronary Intervention for Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'SMC-PCI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PCI group', 'description': 'All consecutive patients with coronary artery disease who underwent percutaneous coronary intervention', 'interventionNames': ['Procedure: Percutaneous coronary intervention']}], 'interventions': [{'name': 'Percutaneous coronary intervention', 'type': 'PROCEDURE', 'description': 'Percutaneous Coronary Intervention Procedure', 'armGroupLabels': ['PCI group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Joo-Yong Hahn, MD, PhD', 'role': 'CONTACT', 'email': 'jyhahn@skku.edu', 'phone': '82-2-3410-6653'}, {'name': 'Ki Hong Choi, MD, PhD', 'role': 'CONTACT', 'email': 'cardiokh@gmail.com', 'phone': '82-2-3410-2575'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Joo-Yong Hahn, MD', 'role': 'CONTACT', 'email': 'jyhahn@skku.edu', 'phone': '82-2-3410-3419'}, {'name': 'Ki Hong Choi, MD', 'role': 'CONTACT', 'email': 'cardiokh@gmail.com', 'phone': '82-2-3410-6653'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joo-Yong Hahn', 'investigatorAffiliation': 'Samsung Medical Center'}}}}