Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT01638832
Status:
UNKNOWN
Last Update Posted:
2012-07-12
First Post:
2012-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Non-alcoholic Fatty Liver Disease and Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 572}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-11', 'studyFirstSubmitDate': '2012-07-05', 'studyFirstSubmitQcDate': '2012-07-11', 'lastUpdatePostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liver fibrosis scores I-IV (METAVIR)', 'description': 'METAVIR fibrosis scores:\n\nI = mild fibrosis II = significant fibrosis III = advanced fibrosis IV = cirrhosis'}], 'secondaryOutcomes': [{'measure': 'Steatosis fibrosis scores I-III', 'description': 'Steatosis scores:\n\n0 = \\<5% I = 5-33% II = 33-66% III = \\>66%'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NASH; coronary artery disease'], 'conditions': ['Nonalcoholic Steatohepatitis (NASH)']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the association of non-alcoholic fatty liver disease and coronary artery disease. All patients presenting for coronary angiogram will receive the following examination:\n\n* Transient Elastography and Controlled Attenuation Parameter using the FibroScan\n* blood examination including biochemical markers The results of non-invasive liver steatosis and fibrosis measurement are compared with the results of coronary angiogram concerning the presence or absence of coronary artery disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, 18 years and older\n* Written consent\n* Coronary angiogram planned\n\nExclusion Criteria:\n\n* Patients with mental diseases\n* Pregnancy or lactation\n* Ascites'}, 'identificationModule': {'nctId': 'NCT01638832', 'briefTitle': 'Association of Non-alcoholic Fatty Liver Disease and Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Association of Non-alcoholic Fatty Liver Disease and Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'JWGUHMED1-005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Transient Elastography (FibroScan), Echosens, Paris, France', 'type': 'DEVICE'}, {'name': 'Controlled Attenuation Parameter (CAP), Echosens, Paris, France', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Frankfurt am Main', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Klinikum der J. W. Goethe-Universität', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'centralContacts': [{'name': 'Mireen Friedrich-Rust, MD', 'role': 'CONTACT', 'email': 'Mireen.Friedrich-Rust@kgu.de'}], 'overallOfficials': [{'name': 'Mireen Friedrich-Rust, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum der J. W. Goethe-Universität Frankfurt am Main'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}}}}