Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-02-25 @ 11:47 PM
Study NCT ID:
NCT02131935
Status:
COMPLETED
Last Update Posted:
2014-05-28
First Post:
2014-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impaired Peripheral Endothelial Function and In-stent Restenosis
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 513}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-24', 'studyFirstSubmitDate': '2014-05-01', 'studyFirstSubmitQcDate': '2014-05-03', 'lastUpdatePostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence or absence of in-stent restenosis', 'timeFrame': 'within 1 year', 'description': 'Based on the Japanese clinical routine, follow-up (F/U) angiography will be performed at six and nine months after PCI with bare-metal stent (BMS) and drug-eluting stent (DES), respectively. ISR was defined as percent diameter stenosis \\>50% at F/U angiography assessed by quantitative coronary angiography.'}], 'secondaryOutcomes': [{'measure': 'Endothelial Function', 'timeFrame': 'within 1 year', 'description': 'Fingertip reactive hyperemia peripheral arterial tonometry (RH-PAT) is a new device that provides noninvasive, automatic, and quantitative evaluation of endothelial dysfunction with low intra- and inter-observer variability. We assess the hypothesis that whether RH-PAT index (RHI) as a marker of endothelial dysfunction could predict occurrence of ISR after percutaneous coronary intervention (PCI). RHI will be measured using Endo-PAT2000 (Itamar Medical, Caesarea, Israel) before PCI (initial RHI) and at follow-up angiography (F/U RHI) in consecutive patients who had successful PCI in de novo coronary lesions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '27317348', 'type': 'DERIVED', 'citation': 'Komura N, Tsujita K, Yamanaga K, Sakamoto K, Kaikita K, Hokimoto S, Iwashita S, Miyazaki T, Akasaka T, Arima Y, Yamamoto E, Izumiya Y, Yamamuro M, Kojima S, Tayama S, Sugiyama S, Matsui K, Nakamura S, Hibi K, Kimura K, Umemura S, Ogawa H. Impaired Peripheral Endothelial Function Assessed by Digital Reactive Hyperemia Peripheral Arterial Tonometry and Risk of In-Stent Restenosis. J Am Heart Assoc. 2016 Jun 17;5(6):e003202. doi: 10.1161/JAHA.116.003202.'}]}, 'descriptionModule': {'briefSummary': 'The investigators assessed the hypothesis that whether RH-PAT index (RHI) as a marker of endothelial dysfunction could predict occurrence of ISR after percutaneous coronary intervention (PCI).', 'detailedDescription': 'This is a prospective observational study of all consecutive patients with coronary artery disease (CAD) treated with PCI at Kumamoto University Hospital between January 2010 and September 2012. Inclusion criteria consisted of patients who were symptomatic for myocardial ischemia and who were undergoing stent implantation for significant CAD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'consecutive patient sampling This is a prospective observational study of all consecutive patients with coronary artery disease (CAD) treated with PCI at Kumamoto University Hospital between January 2010 and September 2012. Inclusion criteria consisted of patients who were symptomatic for myocardial ischemia and who were undergoing stent implantation for significant CAD.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria consisted of patients who were symptomatic for myocardial ischemia and who were undergoing stent implantation for significant CAD.\n\nExclusion Criteria:\n\n* Exclusion criteria were balloon angioplasty only without stent deployment, death during hospitalization, and patients who had comorbidities affected RH-PAT results such as hemodialysis, advanced cancer, after surgery of breast cancer, dementia, collagen disease, and not performing RH-PAT with uncertain reason.'}, 'identificationModule': {'nctId': 'NCT02131935', 'briefTitle': 'Impaired Peripheral Endothelial Function and In-stent Restenosis', 'organization': {'class': 'OTHER', 'fullName': 'Kumamoto University'}, 'officialTitle': 'Impaired Peripheral Endothelial Function as Assessed by Digital Reactive Hyperemia Peripheral Arterial Tonometry and Risk of In-Stent Restenosis', 'orgStudyIdInfo': {'id': '1120'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ISR Group', 'description': 'Patients Group Experienced In-Stent Restenosis (ISR)'}, {'label': 'Non-ISR', 'description': 'Patients Group Without in-stent restenosis (ISR)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '860-8556', 'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'Kumamoto University', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}], 'overallOfficials': [{'name': 'Hisao Ogawa, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kumamoto University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kumamoto University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kenichi Tsujita, MD, PhD', 'investigatorAffiliation': 'Kumamoto University'}}}}