Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT03117218
Status:
UNKNOWN
Last Update Posted:
2017-04-18
First Post:
2017-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlation Between Quantitative Analysis of Coronary MRA and FFR
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 89}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-16', 'studyFirstSubmitDate': '2017-04-12', 'studyFirstSubmitQcDate': '2017-04-12', 'lastUpdatePostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of functionally significant coronary stenosis', 'timeFrame': 'within 1 month', 'description': 'fractional flow reserve \\< 0.8'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Magnetic Resonance Angiography', 'Fractional Flow Reserve']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate whether quantitative analysis of coronary MR angiogram would improve the detection of functionally-significant coronary artery stenosis.', 'detailedDescription': 'Coronary MR angiography is performed with a 3.0-T imager with 32-channel coils. Qunatitative analysis of coronary MR angiogram is evaluated on the basis of the signal intensity (SI) profile along the vessel. Quantitative analysis of coronary MR angiogram (QCMRA) is calculated as \\[1 - (SImin/SIref)\\] x 100, where SImin is minimal SI and SIref is corresponding reference SI. Diagnostic performance of quantitative analysis of coronary MR angiogram for predicting functional significant coronary stenosis was evaluated by using fractional flow reserve (FFR) as the reference standard.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with coronary stenosis on coronary MR angiograms who were planned to undergo invasive coronary angiography.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* 1 or more coronary stenoses in the major coronary artery with a vessel diameter ≥ 2mm on coronary MR angiogram\n* Patient who were planned to undergo invasive coronary angiography and fractional flow reserve\n\nExclusion Criteria:\n\n* clinically unstable patient\n* a history of coronary revascularization\n* infiltrative cardiomyopathy, hypertropic cardiomyopathy, myocarditis\n* contraindication to use of adenosine\n* complete occlusion of target lesion'}, 'identificationModule': {'nctId': 'NCT03117218', 'briefTitle': 'Correlation Between Quantitative Analysis of Coronary MRA and FFR', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Quantitative Analysis of 3T Whole Heart Coronary Magnetic Resonance Angiogram Improves Detection of Functionally Significant Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'B-1408/262-006'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Coronary MR angiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Quantitative analysis of coronary MR angiogram'}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yeonyee E Yoon, MD', 'role': 'CONTACT', 'email': 'yeonyeeyoon@gmail.com', 'phone': '+82-31-787-7072'}], 'facility': 'Seoul National University Bundang Hopsital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Yeonyee E Yoon, MD', 'role': 'CONTACT', 'email': 'yeonyeeyoon@snubh.org', 'phone': '+82-31-787-7072'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Yeonyee E Yoon, MD', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}