Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-04-21 @ 9:02 PM
Study NCT ID:
NCT03179592
Status:
COMPLETED
Last Update Posted:
2020-02-13
First Post:
2017-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VOLtage-based Contrast Media AdaptatioN in Coronary Computed Tomography Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C038192', 'term': 'iopromide'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-11', 'studyFirstSubmitDate': '2017-06-01', 'studyFirstSubmitQcDate': '2017-06-05', 'lastUpdatePostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualitative assessment of image quality', 'timeFrame': '2 years', 'description': 'This will be performed by two independent observers using a semi-quantitative rating scale of 1 - 5. Image quality will be graded on a five-point scoring system: 1 non-diagnostic; 2 limited diagnostic value; 3 adequate (presence of artifacts not limiting detection of luminal stenosis); 4 good; 5 excellent. Image quality assessments will be performed on both the investigative and control groups.'}, {'measure': 'Quantitative assessment of image quality', 'timeFrame': '2 years', 'description': 'Measurements and calculations will be performed by two independent observers who will be blinded to image acquisition parameters. Signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) will be measured for all images.'}], 'secondaryOutcomes': [{'measure': 'Radiation dose of coronary CTA', 'timeFrame': '2 years', 'description': 'Determine the radiation dose (mSv) associated with low-volume contrast injection CCTA protocols.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Computed Tomography'], 'conditions': ['Coronary Artery Disease', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to prospectively evaluate the effectiveness of low-volume contrast media (CM) injection protocols adapted to tube voltage in patients undergoing Coronary Computed Tomography Angiography (CCTA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes 120 patients who present to radiology department for clinically indicated CCTA scan. In order to be included patients must meet all inclusion criteria and none of the exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Referred for a clinically indicated CCTA scan.\n2. Subject must be 18 - 85 years of age.\n3. Subject must provide written informed consent prior to any study-related procedures being performed.\n4. Subject must be willing to comply with all clinical study procedures.\n\nExclusion Criteria:\n\n1. Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:\n\n * By testing (serum or urine beta HCG) within 24 hours before study agent administration, or\n * By surgical sterilization, or\n * Post-menopausal, with minimum one (1) year history without menses.\n2. Subject is chosen by the automated tube voltage selection algorithm (or adjusted by the technologist) to be scanned using a tube voltage that is not 70, 80, 90, 100, 110, 120, or 130 kV.\n3. Subject is chosen by the automated tube voltage selection algorithm (or adjusted by the technologist) to be scanned using a tube voltage that has previously reached the maximum subject number (20 subjects per tube voltage).\n4. Subject has an acute psychiatric disorder.\n5. Subject is unwilling to comply with the requirements of the protocol.\n6. Subject has previously entered this study.\n7. Subject has an allergy against iodinated contrast agents or pharmaceutical stressors used in this study.\n8. Subject has impaired renal function (creatinine \\> 1.5 mg/dl).\n9. Subject is in unstable condition.'}, 'identificationModule': {'nctId': 'NCT03179592', 'acronym': 'VOLCANIC-CTA', 'briefTitle': 'VOLtage-based Contrast Media AdaptatioN in Coronary Computed Tomography Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'VOLtage-based Contrast Media AdaptatioN in Coronary Computed Tomography Angiography (VOLCANIC-CTA): A Prospective Trial', 'orgStudyIdInfo': {'id': 'Pro00060805'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low-volume contrast media injection protocol', 'description': 'Patients will receive a low-volume contrast media (Ultravist 370Mg I/Ml Solution for Injection) injection protocol that is tailored to a specific tube voltage. Tube voltages will be automatically selected by the scanner to be used for the CCTA acquisition.', 'interventionNames': ['Drug: Ultravist 370Mg I/Ml Solution for Injection']}], 'interventions': [{'name': 'Ultravist 370Mg I/Ml Solution for Injection', 'type': 'DRUG', 'otherNames': ['Iopromide'], 'description': 'Reduced contrast-volume injection protocols based on patient specific tube voltage.', 'armGroupLabels': ['Low-volume contrast media injection protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}