Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
Study NCT ID:
NCT04220450
Status:
UNKNOWN
Last Update Posted:
2020-01-07
First Post:
2020-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
T1-mapping by Cardiovascular Magnetic Resonance Imaging to Assess Non-Alcoholic Fatty Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2021-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-06', 'studyFirstSubmitDate': '2020-01-05', 'studyFirstSubmitQcDate': '2020-01-06', 'lastUpdatePostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation NAFLD and liver T1mapping', 'timeFrame': 'cross-sectional within one year', 'description': 'Correlation NAFLD risk score and liver T1-mapping (native and ECV9'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NAFLD', 'Heart Failure', 'Valvular Disease', 'Coronary Disease']}, 'referencesModule': {'references': [{'pmid': '36256728', 'type': 'DERIVED', 'citation': 'Mascherbauer K, Dona C, Koschutnik M, Dannenberg V, Nitsche C, Duca F, Heitzinger G, Halavina K, Steinacher E, Kronberger C, Bardach C, Beitzke D, Loewe C, Waldmann E, Trauner M, Barkto P, Goliasch G, Mascherbauer J, Hengstenberg C, Kammerlander A. Hepatic T1-Time Predicts Cardiovascular Risk in All-Comers Referred for Cardiovascular Magnetic Resonance: A Post-Hoc Analysis. Circ Cardiovasc Imaging. 2022 Oct;15(10):e014716. doi: 10.1161/CIRCIMAGING.122.014716. Epub 2022 Oct 18.'}]}, 'descriptionModule': {'briefSummary': 'On clinically indicated Cardiovascular Magnetic Resonance studies, native T1-times and extracellular volume of the liver will be assessed and findings correlated with established risk calculators for non-alcoholic fatty liver disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All-comer cohort referred for Cardiovascular Magnetic Resonance Imaging', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Referred for Cardiovascular Magnetic Resonance Imaging\n\nExclusion Criteria:\n\n* Non-compatible Devices'}, 'identificationModule': {'nctId': 'NCT04220450', 'briefTitle': 'T1-mapping by Cardiovascular Magnetic Resonance Imaging to Assess Non-Alcoholic Fatty Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'T1-mapping by Cardiovascular Magnetic Resonance Imaging to Assess Non-Alcoholic Fatty Liver Disease', 'orgStudyIdInfo': {'id': 'NAFLD-CMR-2436'}}, 'armsInterventionsModule': {'interventions': [{'name': 'T1 mapping on Cardiovascular Magnetic Resonance Studies', 'type': 'DIAGNOSTIC_TEST', 'description': 'On clinically indicated Cardiovascular Magnetic Resonance Imaging Studies, native T1-times and extracellular volume will be determined'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Andreas Kammerlander, MD PhD', 'role': 'CONTACT', 'email': 'andreas.kammerlander@meduniwien.ac.at', 'phone': '0043 1 40400 46140'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Andreas Kammerlander', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Andreas Kammerlander', 'investigatorAffiliation': 'Medical University of Vienna'}}}}