Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-02-20 @ 7:23 PM
Study NCT ID:
NCT04153903
Status:
UNKNOWN
Last Update Posted:
2019-11-06
First Post:
2019-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrated Coronary Multicenter Imaging Registry - Extended
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': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-03', 'studyFirstSubmitDate': '2019-11-03', 'studyFirstSubmitQcDate': '2019-11-03', 'lastUpdatePostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of computed FFR derived by coronary images and real FFR values', 'timeFrame': 'at registration', 'description': 'FFR values computed by OCT/CT/invasive coronary angiography will be compared by real invasive FFR values'}], 'secondaryOutcomes': [{'measure': 'Adverse event (Death, acute myocardial infarction)', 'timeFrame': '2 years after registration', 'description': 'Death and occurrence of myocardial infarction during follow-up period will be assessed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The coronary images of invasive angiography and optical coherence tomography (or Coronary CT angiography) with FFR(Fractional Flow Reserve) values of the intermediate lesions (50-70% stenosis) will be prospectively registered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Coronary artery disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who underwent coronary CT angiography because of chest pain\n2. Patients who need OCT or FFR evaluation because of intermediate lesions according to invasive angiography (diameter stenosis of 50-70%)\n3. Age: 20-80 yrs\n4. Patients who consent and fully understand the protocol\n5. Patients who consent the clinical follow-up\n6. Patients who can be followed-up\n\nExclusion Criteria:\n\n1. Patients who had contrast allergy\n2. Patients who had unstable blood pressure needing the vasopressors\n3. Patients who had severe left ventricular function (left ventricular ejection fraction\\<30%)\n4. Chronic kidney disease who had Cr level of greater than 2.0 mg/dl\n5. Patients whose expected survival is less than 12 months\n6. Patients who had a severe valvular disease'}, 'identificationModule': {'nctId': 'NCT04153903', 'briefTitle': 'Integrated Coronary Multicenter Imaging Registry - Extended', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Integrated Coronary Multicenter Imaging Registry - Extended', 'orgStudyIdInfo': {'id': '4-2019-0476'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with intermediate lesions', 'description': 'Imaging cohort will be performed invasive angiography and optical coherence tomography (or Coronary CT angiography) with FFR(Fractional Flow Reserve) values of the intermediate lesions (50-70% stenosis)', 'interventionNames': ['Other: OCT, coronary angiography, FFR']}], 'interventions': [{'name': 'OCT, coronary angiography, FFR', 'type': 'OTHER', 'description': 'Coronary images by OCT and angiography and FFR values will be registered.', 'armGroupLabels': ['Patients with intermediate lesions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Division of Cardiology, Cardiovascular Hospital, Yonsei University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}