Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT00932958
Status:
COMPLETED
Last Update Posted:
2012-12-11
First Post:
2009-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physicians International Coronary Computed Tomography Angiography (CCTA) Utilization Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], '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'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-08', 'studyFirstSubmitDate': '2009-07-05', 'studyFirstSubmitQcDate': '2009-07-06', 'lastUpdatePostDateStruct': {'date': '2012-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CCTA utilization parameters and clinical findings', 'timeFrame': 'Two years'}], 'secondaryOutcomes': [{'measure': '90 day MACE, Intended Care Management and Cost Effectiveness for cardiologists interpreting their CCTA studies', 'timeFrame': 'Two years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myocardial Infarction'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'This protocol describes an observational study whose goal is to collect de-identified Coronary CT Angiography (CCTA) acquisition factors and interpretations (findings) from several hundred U.S. and international imaging facilities. The study uses an electronic data capture tool to collect de-identified CCTA utilization parameters and clinical findings in order to create a multi-center registry. This registry will be used for scientific analysis and publication of pertinent medical trends such as CT utilization, radiation dose, and common cardiovascular findings. The registry will be used to determine areas of interest for future randomized controlled trials.\n\nAll data will be collected with patient identifiers removed and in complete accordance with HIPAA regulations. All data will be analyzed in aggregate, thus further minimizing the risk of patient confidentiality violations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults (18 or older) who are scheduled to undergo a CCTA imaging procedure.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult participants who are able and willing to consent for themselves\n* Patients scheduled for CCTA examination\n\nExclusion Criteria:\n\n* Patients who did not complete the planned CT imaging procedure due to mechanical error of the CT machine.'}, 'identificationModule': {'nctId': 'NCT00932958', 'acronym': 'BIGPICTURE', 'briefTitle': 'Physicians International Coronary Computed Tomography Angiography (CCTA) Utilization Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'MDDX LLC'}, 'officialTitle': 'Physicians International CCTA Utilization Registry', 'orgStudyIdInfo': {'id': 'bigPICTURE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All comers >18 yrs old', 'description': 'This study is observational, studying patients who are already scheduled to undergo CCTA. Minors and those unable to consent to the study are excluded.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94111', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'MDDX', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Dan Gebow, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MDDX LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MDDX LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}