Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-02-28 @ 3:48 AM
Study NCT ID:
NCT01331902
Status:
UNKNOWN
Last Update Posted:
2011-04-08
First Post:
2011-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Hyperemic Efficacy Between Nicorandil and Adenosine for Fractional Flow Reserve (FFR) Measurement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-07', 'studyFirstSubmitDate': '2011-04-01', 'studyFirstSubmitQcDate': '2011-04-07', 'lastUpdatePostDateStruct': {'date': '2011-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fractional Flow Reserve at Maximal Hyperemia', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Time to Maximal Hyperemia', 'timeFrame': '1 day'}, {'measure': 'Changes in Heart Rate', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Adenosine', 'Nicorandil', 'Fractional Flow Reserve', 'Maximal Hyperemia'], 'conditions': ['Coronary Artery Disease', 'Myocardial Ischemia']}, 'referencesModule': {'references': [{'pmid': '23396491', 'type': 'DERIVED', 'citation': 'Jang HJ, Koo BK, Lee HS, Park JB, Kim JH, Seo MK, Yang HM, Park KW, Nam CW, Doh JH, Kim HS. Safety and efficacy of a novel hyperaemic agent, intracoronary nicorandil, for invasive physiological assessments in the cardiac catheterization laboratory. Eur Heart J. 2013 Jul;34(27):2055-62. doi: 10.1093/eurheartj/eht040. Epub 2013 Feb 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of nicorandil in the achievement of maximal coronary hyperemia compared with adenosine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non -infarct related, patients with moderate coronary artery stenosis\n* normal left ventricular ejection fraction on echocardiogram\n\nExclusion Criteria:\n\n* infarct-related arteries or clinically unstable state\n* collateral blood flow to the target vessel is shown\n* atrioventricular block on electrocardiogram\n* reduced left ventricular ejection fraction (\\<50%) or left ventricular hypertrophy on echocardiogram\n* contraindication of adenosine\n* bronchial asthma'}, 'identificationModule': {'nctId': 'NCT01331902', 'briefTitle': 'Comparison of Hyperemic Efficacy Between Nicorandil and Adenosine for Fractional Flow Reserve (FFR) Measurement', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'orgStudyIdInfo': {'id': 'H-1101-069-348'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adenosine Followed by Nicorandil', 'interventionNames': ['Other: Maximal Hyperemia with Adenosine Followed by Nicorandil']}, {'type': 'EXPERIMENTAL', 'label': 'Nicorandil Followed by Adenosine', 'interventionNames': ['Other: Maximal Hyperemia with Nicorandil Followed by Adenosine']}], 'interventions': [{'name': 'Maximal Hyperemia with Adenosine Followed by Nicorandil', 'type': 'OTHER', 'description': 'Firstly FFR was measured with intravenous adenosine infusion (140 μg•min-1•kg-1) via femoral vein or antecubital vein. Secondly with intracoronary adenosine bolus injection (80μg, 40μg to LCA and RCA, respectively). Lastly with intracoronary nicorandil bolus injection (1mg followed by 2mg).', 'armGroupLabels': ['Adenosine Followed by Nicorandil']}, {'name': 'Maximal Hyperemia with Nicorandil Followed by Adenosine', 'type': 'OTHER', 'description': 'Firstly FFR was measured with intracoronary nicorandil bolus injection (1mg followed by 2mg). Secondly with intravenous adenosine infusion (140 μg•min-1•kg-1) via femoral vein or antecubital vein. Lastly with intracoronary adenosine bolus injection (80μg, 40μg to LCA and RCA, respectively).', 'armGroupLabels': ['Nicorandil Followed by Adenosine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ho-Jun Jang, MD', 'role': 'CONTACT', 'email': 'wingal@naver.com', 'phone': '82-2-2072-3757'}, {'name': 'Bon-Kwon Koo, MD.PhD', 'role': 'CONTACT', 'email': 'bkkoo@snu.ac.kr', 'phone': '82-2-2072-2062'}], 'facility': 'Cardiovascular Center, Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Ho-Jun Jang, MD', 'role': 'CONTACT', 'email': 'wingal@naver.com', 'phone': '82-2-2072-3757'}, {'name': 'Bon-Kwan Koo, MD.PhD', 'role': 'CONTACT', 'email': 'bkkoo@snu.ac.kr', 'phone': '82-2-2072-2062'}], 'overallOfficials': [{'name': 'Bon-Kwon Koo, MD. PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University Boramae Hospital', 'class': 'OTHER'}, {'name': 'Inje University Ilsan Paik Hospital', 'class': 'OTHER'}, {'name': 'Keimyung University Dongsan Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Bon- Kwon Koo / prof', 'oldOrganization': 'Cardiovascular Center, Seoul National University Hospital'}}}}