Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT02845505
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-09
First Post:
2016-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravascular Ultrasound Prediction of Myocardial Size and Coronary Computed Tomography-Derived Ischemic Burden for Coronary Lesion
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-06', 'studyFirstSubmitDate': '2016-07-13', 'studyFirstSubmitQcDate': '2016-07-24', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mathematically-predicted ischemic size (by using IVUS parameters) vs. CAMS-derived myocardial size subtended to the stenotic segment', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Impact of plaque characteristics (attenuated plaque, plaque rupture, calcification, thrombosis, etc.) assessed by IVUS on the ischemic burden assessed by CAMS', 'timeFrame': '1 year'}, {'measure': 'Incidence of MACE comprising death, nonfatal myocardial infarction or target vessel revascularization', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intravascular ultrasonography', 'Computed Tomography'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The aims of this study are 1) to identify IVUS determinants of the CAMS-derived myocardial territories subtended to the diseased vessels, 2) to find IVUS determinant for the extent of CAMS-derived myocardial size, and 3) to develop the mathematical model that integrates the IVUS information about myocardial territory and stenosis severity and predicts the extent of CAMS-derived myocardial size.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who undergo coronary computed tomography angiography, invasive coronary angiography and IVUS assessment prior to intervention will be enrolled. The patients should have at least one coronary artery lesion (including non-left main and isolated left main disease) with visually estimated diameter stenosis \\>50%', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20years or older\n* Patients who have at least one epicardial coronary artery lesion (including isolated left main disease or side branch) with visually estimated diameter stenosis \\>50% and take coronary angiography, CT angiography and IVUS\n* Willing and able to provide informed written consent\n\nExclusion Criteria:\n\n* In-stent restenosis\n* Bypass graft\n* Suspected coronary spasm even after sufficient nitrate injected\n* Cases in which the IVUS imaging catheter failed to cross the lesion\n* Poor quality IVUS or CT images\n* Visible collateral flow on angiography'}, 'identificationModule': {'nctId': 'NCT02845505', 'acronym': 'IVUS-CAMS', 'briefTitle': 'Intravascular Ultrasound Prediction of Myocardial Size and Coronary Computed Tomography-Derived Ischemic Burden for Coronary Lesion', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Intravascular Ultrasound Prediction of Myocardial Size and Coronary Computed Tomography-Derived Ischemic Burden for Coronary Lesion', 'orgStudyIdInfo': {'id': 'AMCCV 2016-06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IVUS-CAMS', 'description': 'patients who undergo coronary computed tomography angiography, invasive coronary angiography and IVUS', 'interventionNames': ['Other: Intravascular Ultrasound, coronary computed tomography angiography']}], 'interventions': [{'name': 'Intravascular Ultrasound, coronary computed tomography angiography', 'type': 'OTHER', 'armGroupLabels': ['IVUS-CAMS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'state': 'Songpa-Gu', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Anyang', 'country': 'South Korea', 'facility': 'Hallym University Sacred Heart hospital', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gangneung', 'country': 'South Korea', 'facility': 'Gangneung Asan Hospital', 'geoPoint': {'lat': 37.75266, 'lon': 128.87239}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Hallym University Dongtan Sacred Heart Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Inje university Pusan Paik hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Kosin University Gospel Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Veterans Hospital Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'city': 'Yangsan', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Young-Hak Kim, MD, PhD', 'investigatorAffiliation': 'Asan Medical Center'}}}}