Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-01-27 @ 5:45 AM
Study NCT ID:
NCT02030704
Status:
COMPLETED
Last Update Posted:
2018-09-11
First Post:
2014-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CCTA-based Coronary Plaque Characterization and High-sensitive Troponin T for the Prediction of Cardiovascular Outcomes
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': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2014-01-07', 'studyFirstSubmitQcDate': '2014-01-07', 'lastUpdatePostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac death', 'timeFrame': 'two years'}, {'measure': 'Nonfatal myocardial infarction', 'timeFrame': 'two years'}], 'secondaryOutcomes': [{'measure': 'Myocardial revascularization including PCI and CABG', 'timeFrame': 'two years', 'description': 'PCI - Percutaneous Coronary Intervention CABG - Coronary Artery Bypass Grafting'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Noninvasive Plaque Characterization']}, 'referencesModule': {'references': [{'pmid': '20306078', 'type': 'BACKGROUND', 'citation': 'Korosoglou G, Mueller D, Lehrke S, Steen H, Hosch W, Heye T, Kauczor HU, Giannitsis E, Katus HA. Quantitative assessment of stenosis severity and atherosclerotic plaque composition using 256-slice computed tomography. Eur Radiol. 2010 Aug;20(8):1841-50. doi: 10.1007/s00330-010-1753-3. Epub 2010 Mar 20.'}]}, 'descriptionModule': {'briefSummary': 'To determine the ability of semi-automated plaque assessment in cardiac computed tomography angiography (CCTA) and high sensitive troponin T (hsTnT) for the risk stratification of patients at intermediate risk for coronary artery disease (CAD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients scheduled to undergo CCTA', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical indication for CCTA according to the current appropriate use criteria\n\nExclusion Criteria:\n\n* non-sinus rhythm\n* acute coronary syndromes\n* cardiomyopathies\n* moderate or severe valvular disease\n* elevated serum creatinine (\\>1.5 mg/dl)\n* history or ECG signs of previous myocardial infarction\n* severe iodine allergy.'}, 'identificationModule': {'nctId': 'NCT02030704', 'briefTitle': 'CCTA-based Coronary Plaque Characterization and High-sensitive Troponin T for the Prediction of Cardiovascular Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Heidelberg'}, 'officialTitle': "Comprehensive 'Bio-Imaging' Using Quantitative Coronary Plaque Composition Assessment and the High-sensitive Troponin T for the Prediction of Cardiac Outcomes.", 'orgStudyIdInfo': {'id': 'HDCCTA01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Atherosclerotic Plaque'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'University of Heidelberg, Department of Cardiology', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '1122', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'MTA-SE Lendület Cardiovascular Imaging Research Group, Heart and Vascular Center, Semmelweis University', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'overallOfficials': [{'name': 'Grigorios Korosoglou, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Heidelberg, Department of Cardiology, Heidelberg, Germany.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Semmelweis University Heart and Vascular Center', 'class': 'OTHER'}, {'name': 'Heidelberg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'GKorosoglou', 'investigatorAffiliation': 'University Hospital Heidelberg'}}}}