Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-03-13 @ 8:09 PM
Study NCT ID:
NCT02218060
Status:
COMPLETED
Last Update Posted:
2018-05-02
First Post:
2014-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coronary CT Angiography Using a Novel 3rd Generation Dual-Source CT System
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2014-08-14', 'studyFirstSubmitQcDate': '2014-08-14', 'lastUpdatePostDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiation dose and contrast material', 'timeFrame': 'one year', 'description': 'To determine the potential for reductions in radiation dose and contrast material requirements by performing coronary CT angiography at low tube potential with the new CT system.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic accuracy', 'timeFrame': 'one year', 'description': 'To determine the diagnostic accuracy of coronary CT angiography performed with the new CT system using coronary catheterization or nuclear myocardial perfusion imaging as reference standards.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Coronary CT angiography is used to examine the coronary arteries in a non-invasive way when a patient is suspected of having coronary artery disease. The test, however, requires relatively high levels of radiation, which have been linked to DNA damage and cancer, and the use of contrast material, which can affect kidney function. The SOMATOM Force, a new third-generation CT scanner manufactured by Siemens, was recently installed at MUSC and holds the potential to obtain quality images while also reducing radiation dose and contrast material. This study aims to test the diagnostic ability of the SOMATOM Force in detecting coronary artery disease and also see if radiation dose and contrast material are reduced compared to the previous 2nd generation scanners. It is suspected that the Force will provide clinical quality images while decreasing radiation dose and contrast material required.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must be between 18-90 years of age.\n* Subject must have been referred for a clinically indicated cardiac catheterization or nuclear cardiac perfusion study.\n* Subject must provide written informed consent prior to any study-related procedures being performed.\n* Subject must be willing to comply with all clinical study procedures.\n\nExclusion Criteria:\n\n* Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:\n\n * By testing (urine βHCG) within 24 hours before contrast agent administration, or\n * By surgical sterilization, or\n * Post menopausal, with minimum one (1) year history without menses.\n* Subject has an acute psychiatric disorder or is cognitively impaired.\n* Subject is using or is dependent on substances of abuse.\n* Subject is unwilling to comply with the requirements of the protocol.\n* Subject has decreased renal function (eGFR \\<45)\n* Subject has an allergy against iodinated contrast agents.\n* Subject is in acute unstable condition.'}, 'identificationModule': {'nctId': 'NCT02218060', 'briefTitle': 'Coronary CT Angiography Using a Novel 3rd Generation Dual-Source CT System', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Coronary CT Angiography Using a Novel 3rd Generation Dual-Source CT System: Diagnostic Performance and Potential for Reduction in Radiation Dose and Contrast Material Requirement', 'orgStudyIdInfo': {'id': 'Force Cardiac'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Force', 'description': 'Patients receiving coronary CT angiography on the SOMATOM Force before clinically indicated cardiac catheterization or after clinically indicated nuclear stress test', 'interventionNames': ['Procedure: Coronary CT angiography on SOMATOM Force']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Patients who have already received comparable CT examinations on current routine 2nd generation dual-source CT systems', 'interventionNames': ['Procedure: Previous coronary CT angiography on 2nd generation CT scanner']}], 'interventions': [{'name': 'Coronary CT angiography on SOMATOM Force', 'type': 'PROCEDURE', 'description': 'Coronary CT angiography using iodinated contrast; metoprolol and/or nitroglycerin may also be administered on a per-patient basis', 'armGroupLabels': ['Force']}, {'name': 'Previous coronary CT angiography on 2nd generation CT scanner', 'type': 'PROCEDURE', 'description': 'Clinically indicated coronary CT angiography previously performed on a 2nd generation CT scanner', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29401', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'MUSC Ashley River Tower', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'U. Joseph Schoepf, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'U. Joseph Schoepf, MD', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}