Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT01197703
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2010-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
European Cardio Computer Tomography Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-13', 'studyFirstSubmitDate': '2010-09-07', 'studyFirstSubmitQcDate': '2010-09-07', 'lastUpdatePostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'collect data', 'timeFrame': 'June 2009-', 'description': 'The general aim of the Registry is to collect data from a large number of patients regarding the indications, general use, safety, and therapeutic implications of cardiac CT in European clinical practice.'}], 'secondaryOutcomes': [{'measure': 'effect of coronary CT angiography', 'timeFrame': 'June 2009-', 'description': 'A first specific aim of the Registry is the analysis of the effect of coronary CT angiography on downstream resource utilization, revascularization procedures, and prognosis in patients with known or suspected coronary artery disease'}, {'measure': 'analysis of radiation exposure during coronary CT angiography', 'timeFrame': 'June 2009-', 'description': 'The second specific aim is the analysis of radiation exposure during coronary CT angiography and the identification of parameters that influence radiation exposure, with the potential to provide specific guidance for interventions to lower radiation dose in the future'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Clinical Practice Cardiac CT', 'Clinical Implications Coronary CT Angiography', 'Radiation Exposure of Coronary CT Angiography', 'Registry'], 'conditions': ['Consecutive Patients Undergoing Computed Tomography of the Heart for Clinical Indications']}, 'descriptionModule': {'briefSummary': 'The European Cardiac CT Registry has the unique potential to provide important data that will help to clarify the clinical role of cardiac computed tomography (CT), to create guidelines and recommendations for its use, and to identify the most important areas that require specific further research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients that are studies by computed tomography of the heart for clinical indications', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion of all consecutive patients with accomplished or attempted CT imaging of the heart (whether imaging of the coronary arteries or other structures of the heart)\n* Informed consent to be entered in the registry.\n* Inclusion of all consecutive patients with accomplished or attempted coronary CT angiography.\n* Inclusion of all patients who undergo coronary CT angiography for clinical indications, with separate analysis of patients with suspected coronary artery disease and previously known coronary artery disease.\n\nExclusion Criteria:\n\n\\- Besides the absence of informed consent, and cardiac CT studies performed as part of a research protocol, no exclusion criteria exist.'}, 'identificationModule': {'nctId': 'NCT01197703', 'briefTitle': 'European Cardio Computer Tomography Registry', 'organization': {'class': 'OTHER', 'fullName': 'Stiftung Institut fuer Herzinfarktforschung'}, 'officialTitle': 'European Cardio CT Registry', 'orgStudyIdInfo': {'id': 'Euro CT'}}, 'contactsLocationsModule': {'locations': [{'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Kerckhoff Klinik GmbH', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'Elisabeth Krankenhaus', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Cardioangiologisches Centrum Bethanien', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Göppingen', 'country': 'Germany', 'facility': 'Klinik am Eichert', 'geoPoint': {'lat': 48.70354, 'lon': 9.65209}}, {'city': 'München', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'München', 'country': 'Germany', 'facility': 'Herzzentrum Bogenhausen', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Traunstein', 'country': 'Germany', 'facility': 'Klinikum Traunstein', 'geoPoint': {'lat': 47.86825, 'lon': 12.64335}}], 'overallOfficials': [{'name': 'Stephan Achenbach, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitätsklinikum Erlangen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stiftung Institut fuer Herzinfarktforschung', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}