Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-02-26 @ 2:16 AM
Study NCT ID:
NCT02291718
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2014-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Thoracoabdominal Arortic CTA Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017545', 'term': 'Aortic Aneurysm, Thoracic'}, {'id': 'D000094624', 'term': 'Aortic Aneurysm, Thoracoabdominal'}], 'ancestors': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007479', 'term': 'Iopamidol'}], 'ancestors': [{'id': 'D014283', 'term': 'Triiodobenzoic Acids'}, {'id': 'D007463', 'term': 'Iodobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lynne.koweek@duke.edu', 'phone': '919-684-8111', 'title': 'Dr. Lynne Koweek', 'organization': 'Duke University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Isovue 300 (75mL)', 'description': '75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Isovue 370 (75mL)', 'description': '75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Isovue 370 (60mL)', 'description': '60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Radiation Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Isovue 300 75mL', 'description': 'Isovue 300 75mL injected 120 kVp 250 mAs\n\nIsovue: iodine contrast'}, {'id': 'OG001', 'title': 'Isovue 370 75mL', 'description': 'Isovue 370 75mL injected 100 kVp 240 mAs\n\nIsovue: iodine contrast'}, {'id': 'OG002', 'title': 'Isovue 370 60mL', 'description': 'Isovue 370 60mL injected 100 kVp 240 mAs\n\nIsovue: iodine contrast'}], 'classes': [{'categories': [{'measurements': [{'value': '35.1', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '25.4', 'spread': '5.3', 'groupId': 'OG001'}, {'value': '25.5', 'spread': '7.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'unitOfMeasure': 'mSv', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Signal to Noise Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Isovue 300 75mL', 'description': 'Isovue 300 75mL injected 120 kVp 250 mAs\n\nIsovue: iodine contrast'}, {'id': 'OG001', 'title': 'Isovue 370 75mL', 'description': 'Isovue 370 75mL injected 100 kVp 240 mAs\n\nIsovue: iodine contrast'}, {'id': 'OG002', 'title': 'Isovue 370 60mL', 'description': 'Isovue 370 60mL injected 100 kVp 240 mAs\n\nIsovue: iodine contrast'}], 'classes': [{'categories': [{'measurements': [{'value': '12.0', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '3.5', 'groupId': 'OG001'}, {'value': '13.8', 'spread': '6.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'Calculated as the ratio of mean attenuation values divided by the standard deviation of attenuation values gathered using a circular region of interest in the thoracic aorta.', 'unitOfMeasure': 'Signal-to-Noise Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Hiatus region of each subject group'}, {'type': 'SECONDARY', 'title': 'Hounsfield Unit Attenuation Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Isovue 300 75mL', 'description': 'Isovue 300 75mL injected 120 kVp 250 mAs\n\nIsovue: iodine contrast'}, {'id': 'OG001', 'title': 'Isovue 370 75mL', 'description': 'Isovue 370 75mL injected 100 kVp 240 mAs\n\nIsovue: iodine contrast'}, {'id': 'OG002', 'title': 'Isovue 370 60mL', 'description': 'Isovue 370 60mL injected 100 kVp 240 mAs\n\nIsovue: iodine contrast'}], 'classes': [{'categories': [{'measurements': [{'value': '289.7', 'spread': '23.8', 'groupId': 'OG000'}, {'value': '400.9', 'spread': '31.1', 'groupId': 'OG001'}, {'value': '393.9', 'spread': '28.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'Grayscale values on CT scans are given as Hounsfield units. These Hounsfield units reflect the attenuation of x-ray beams traversing the aortic lumen. We will use Hounsfield units to assess whether the tool contrast agents achieve similar attenuation characteristics essential for diagnosing aortic abnormalities. We will use circular regions of interest in the thoracic aorta to extract the Hounsfield unit measurements.', 'unitOfMeasure': 'Hounsfield units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Variation in Contrast for the Entire Vascular System (coV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Isovue 300 75mL', 'description': 'Isovue 300 75mL injected 120 kVp 250 mAs\n\nIsovue: iodine contrast'}, {'id': 'OG001', 'title': 'Isovue 370 75mL', 'description': 'Isovue 370 75mL injected 100 kVp 240 mAs\n\nIsovue: iodine contrast'}, {'id': 'OG002', 'title': 'Isovue 370 60mL', 'description': 'Isovue 370 60mL injected 100 kVp 240 mAs\n\nIsovue: iodine contrast'}], 'classes': [{'categories': [{'measurements': [{'value': '0.113', 'spread': '0.073', 'groupId': 'OG000'}, {'value': '0.124', 'spread': '0.063', 'groupId': 'OG001'}, {'value': '0.107', 'spread': '0.059', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'The change in contrast was measured at the proximal segment of the aorta and at the Iliac arteries for each subject.', 'unitOfMeasure': 'unitless', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Isovue 300 (75mL)', 'description': '75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan'}, {'id': 'FG001', 'title': 'Isovue 370 (75mL)', 'description': '75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT'}, {'id': 'FG002', 'title': 'Isovue 370 (60mL)', 'description': '60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Isovue 300 (75mL)', 'description': '75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan'}, {'id': 'BG001', 'title': 'Isovue 370 (75mL)', 'description': '75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT'}, {'id': 'BG002', 'title': 'Isovue 370 (60mL)', 'description': '60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-22', 'studyFirstSubmitDate': '2014-10-23', 'resultsFirstSubmitDate': '2016-09-28', 'studyFirstSubmitQcDate': '2014-11-11', 'lastUpdatePostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-06', 'studyFirstPostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiation Dose', 'timeFrame': '30 minutes'}], 'secondaryOutcomes': [{'measure': 'Signal to Noise Ratio', 'timeFrame': '30 minutes', 'description': 'Calculated as the ratio of mean attenuation values divided by the standard deviation of attenuation values gathered using a circular region of interest in the thoracic aorta.'}, {'measure': 'Hounsfield Unit Attenuation Values', 'timeFrame': '30 minutes', 'description': 'Grayscale values on CT scans are given as Hounsfield units. These Hounsfield units reflect the attenuation of x-ray beams traversing the aortic lumen. We will use Hounsfield units to assess whether the tool contrast agents achieve similar attenuation characteristics essential for diagnosing aortic abnormalities. We will use circular regions of interest in the thoracic aorta to extract the Hounsfield unit measurements.'}, {'measure': 'Variation in Contrast for the Entire Vascular System (coV)', 'timeFrame': '30 minutes', 'description': 'The change in contrast was measured at the proximal segment of the aorta and at the Iliac arteries for each subject.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Suspected or confirmed', 'TAA', 'Computed tomography angiography', 'CTA', 'Contrast agent', 'Radiation dose', 'Thoracoabdominal aortic aneurysm'], 'conditions': ['Thoracic Aortic Aneurysm']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the contrast agents and imaging techniques used for thoracoabdominal aortic imaging in CT. Imaging parameters and contrast volume are changed and adjusted based on the contrast agent, since contrast agents have varying iodine concentrations. If the contrast iodine concentration is higher, it may be possible to adjust the imaging parameters and lower the overall radiation dose to the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing thoracoabdominal aortic (TAA) CTA\n* Able to provide informed consent\n* Body Mass Index (BMI) equal to or less than 30\n\nExclusion Criteria:\n\n* Creatinine greater than 2.0\n* Allergy to contrast media\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT02291718', 'briefTitle': 'Thoracoabdominal Arortic CTA Study', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Comparison of High Iodine Concentration Contrast Material (Isovue 370) vs Standard Protocol (Isovue 300) in Thoracoabdominal Aortic Computed Tomographic Angiography (CTA) for Radiation Dose Reduction', 'orgStudyIdInfo': {'id': 'Pro00048275'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Isovue 300 75mL', 'description': 'Isovue 300 75mL injected 120 kVp 250 mAs', 'interventionNames': ['Drug: Isovue']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Isovue 370 75mL', 'description': 'Isovue 370 75mL injected 100 kVp 240 mAs', 'interventionNames': ['Drug: Isovue']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Isovue 370 60mL', 'description': 'Isovue 370 60mL injected 100 kVp 240 mAs', 'interventionNames': ['Drug: Isovue']}], 'interventions': [{'name': 'Isovue', 'type': 'DRUG', 'description': 'iodine contrast', 'armGroupLabels': ['Isovue 300 75mL', 'Isovue 370 60mL', 'Isovue 370 75mL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}