Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-02 @ 1:50 AM
Study NCT ID:
NCT05716568
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2015-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Tailored Contrast Volume for Preoperative CT Angiography of the Aorta
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000784', 'term': 'Aortic Dissection'}], 'ancestors': [{'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D000094665', 'term': 'Dissection, Blood Vessel'}, {'id': 'D000094683', 'term': 'Acute Aortic Syndrome'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-27', 'studyFirstSubmitDate': '2015-12-15', 'studyFirstSubmitQcDate': '2023-01-27', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in contrast dose', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Reduction in contrast dose while maintaining image quality'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CT-angiography', 'Aortic aneurysm', 'Aortic dissection', 'Pre-operative', 'Contrast dose reduction'], 'conditions': ['Aortic Aneurysm']}, 'descriptionModule': {'briefSummary': 'An in-house calculator was developed to calculate the appropriate contrast dose, rather than standardly administering a 120ml dose. This study aims for a more uniform contrast enhancement in patients by means of adjusting (lowering) contrast dose to patient parameters.', 'detailedDescription': 'Until now, CT scans in our and many other institutions are being performed with a fixed standard contrast dose specific for every protocol, independent of patient characteristics. However, many if not all patients would benefit from a contrast dose reduction, as long as image quality is not impaired. This is especially beneficial to patients with impaired renal function.\n\nFor this purpose, we researched previous literature as well as data from previously scanned patients with standard dose, to formulate a contrast dose calculation adapted to patient parameters.\n\nAn in-house calculator was developed to calculate the optimal contrast dose dependent on patient length, weight and heartrate.\n\nA total of 60 CT-scans will be performed and retrospectively collected. Patients are randomly assigned to one of three groups : 1/ Standard dose of 120ml; 2/ Calculated dose (40-150ml) 3/ Calculated dose -50% (20-120ml). In case of reduced kidney function, patients were randomly divided between group 2 and 3 (reduced contrast dose).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients requiring CT-angiography of the aorta as requested by clinician\n* For aneurysm detection or follow-up\n* Or for dissection follow-up\n* Thoraco-abdominal aorta or abdominal aorta\n\nExclusion Criteria:\n\n* Contra-indications for contrast administration (severe renal impairment or adverse reactions)\n* Previously endovascular repair of the aorta\n* Only thoracic aorta\n* No informed consent\n* Contrast injection at 4cc/second not possible'}, 'identificationModule': {'nctId': 'NCT05716568', 'briefTitle': 'Patient Tailored Contrast Volume for Preoperative CT Angiography of the Aorta', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Patient Tailored Contrast Volume for Preoperative CT Angiography of the Aorta: A Prospective Study Based on Patient Heart Rate and Body Surface Area Differences', 'orgStudyIdInfo': {'id': 'S58042'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard contrast dose', 'description': 'Standard contrast dose administration', 'interventionNames': ['Other: Contrast dose reduction, CT-angiography']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Calculated contrast dose', 'description': 'Contrast dose by calculation', 'interventionNames': ['Other: Contrast dose reduction, CT-angiography']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Calculated contrast dose -50%', 'description': 'Contrast dose by calculation, with extra dilution by 50%.', 'interventionNames': ['Other: Contrast dose reduction, CT-angiography']}], 'interventions': [{'name': 'Contrast dose reduction, CT-angiography', 'type': 'OTHER', 'description': 'Contrast dose reduction for CT-angiography in pre-operative aorta', 'armGroupLabels': ['Calculated contrast dose', 'Calculated contrast dose -50%', 'Standard contrast dose']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Geert Maleux, Prof Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}