Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2026-01-01 @ 3:54 PM
Study NCT ID:
NCT06338761
Status:
COMPLETED
Last Update Posted:
2025-05-21
First Post:
2024-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Switching to E-cigarette After PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D000072137', 'term': 'Vaping'}, {'id': 'D012907', 'term': 'Smoking'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17973}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-17', 'studyFirstSubmitDate': '2024-03-24', 'studyFirstSubmitQcDate': '2024-03-24', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACE', 'timeFrame': '5 years after PCI', 'description': 'Major adverse cardiac event'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular death', 'timeFrame': '5 years after PCI', 'description': 'death from cardiovascular cause'}, {'measure': 'All-cause death', 'timeFrame': '5 years after PCI', 'description': 'death from any cause'}, {'measure': 'Spontaneous myocardial infarction', 'timeFrame': '5 years after PCI', 'description': 'MI with hospitalization'}, {'measure': 'Repeat revascularization', 'timeFrame': '5 years after PCI', 'description': 'additional PCI or CABG'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Percutaneous coronary intervention', 'E-cigarette', 'Smoking'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '39429032', 'type': 'DERIVED', 'citation': 'Kang D, Choi KH, Kim H, Park H, Heo J, Park TK, Lee JM, Cho J, Yang JH, Hahn JY, Choi SH, Gwon HC, Song YB. Prognosis after switching to electronic cigarettes following percutaneous coronary intervention: a Korean nationwide study. Eur Heart J. 2025 Jan 3;46(1):84-95. doi: 10.1093/eurheartj/ehae705.'}]}, 'descriptionModule': {'briefSummary': 'Despite the increasing popularity of electronic cigarettes (E-cigarettes), the prognostic impact of switching to E-cigarettes in smokers with coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI) remains uncertain.', 'detailedDescription': 'Recently, several studies have reported that, although lower than combustible cigarette users, E-cigarette users had a significantly higher risk of future myocardial infarction (MI) or cardiovascular disease compared with non-smokers or quitters. However, because all previous studies has focused on the general healthy population, these results cannot be extrapolated for patients who already proven atherosclerotic cardiovascular disease (ASCVD), such as undergoing percutaneous coronary intervention (PCI) for coronary artery disease (CAD). Although Busch et al. previously reported that a significant minority of patients are using E-cigarettes post-acute coronary syndrome smokers, a paucity of data exists regarding the impact of such transitions on clinical outcomes in current smoker patients with CAD who have undergone PCI. In light of these considerations, the current study sought to address this gap in knowledge by evaluating the prognostic implications of smoking habit changes, including E-cigarette use, among CAD patients with current smoking status following PCI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with coronary artery disease who underwent health screening 3 years before and after the PCI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who underwent health screening 3 years before and after the PCI\n\nExclusion Criteria:\n\n* history of cancer\n* history of ischemic stroke\n* died within the first 3 months of follow-up from the index date\n* Newly developed acute MI or received additional PCI or CABG from the index PCI date to the study index date'}, 'identificationModule': {'nctId': 'NCT06338761', 'acronym': 'E-cig-PCI', 'briefTitle': 'Switching to E-cigarette After PCI', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Prognostic Impact of Switching to E-Cigarette Use in Smokers With Coronary Artery Disease Following Percutaneous Coronary Intervention: A Nationwide Cohort Study', 'orgStudyIdInfo': {'id': 'E-cigarette PCI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Continued combustible cigarette use', 'description': 'continued combustible cigarettes users after PCI'}, {'label': 'Switching to E-cigarette', 'description': 'switching to E-cigarette users after PCI', 'interventionNames': ['Behavioral: Switching to E-cigarette']}, {'label': 'Quitter', 'description': 'quitters after PCI', 'interventionNames': ['Behavioral: Smoking cessation']}], 'interventions': [{'name': 'Smoking cessation', 'type': 'BEHAVIORAL', 'description': 'Stop smoking', 'armGroupLabels': ['Quitter']}, {'name': 'Switching to E-cigarette', 'type': 'BEHAVIORAL', 'description': 'Switching to E-cigarette', 'armGroupLabels': ['Switching to E-cigarette']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Ki Hong Choi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ki Hong Choi', 'investigatorAffiliation': 'Samsung Medical Center'}}}}