Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-04 @ 9:36 PM
Study NCT ID:
NCT03138434
Status:
TERMINATED
Last Update Posted:
2019-07-05
First Post:
2017-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advanced MRI in AAA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Sufficient acquisitions for DCE-MRI and 4D flow, but not for T1/T2-mapping due to lack of ILT in some participants.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-02', 'studyFirstSubmitDate': '2017-05-01', 'studyFirstSubmitQcDate': '2017-05-01', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wall shear stress (WSS)', 'timeFrame': 'Time of MRI scan', 'description': 'Primary outcome of 4D flow MRI'}, {'measure': 'Kinetic transport constant (Ktrans)', 'timeFrame': 'Time of MRI scan', 'description': 'Primary outcome of DCE-MRI'}, {'measure': 'T1 relaxation time', 'timeFrame': 'Time of MRI scan', 'description': 'Primary outcome of T1 mapping'}, {'measure': 'T2 relaxation time', 'timeFrame': 'Time of MRI scan', 'description': 'Primary outcome of T2 mapping'}], 'secondaryOutcomes': [{'measure': 'Peak flow velocity inside the aneurysm', 'timeFrame': 'Time of MRI scan', 'description': 'Secondary outcome of 4D flow MRI'}, {'measure': 'Location of peak wall shear stress', 'timeFrame': 'Time of MRI scan', 'description': 'Secondary outcome of 4D flow MRI'}, {'measure': 'Flow velocity at aneurysm entrance', 'timeFrame': 'Time of MRI scan', 'description': 'Secondary outcome of 4D flow MRI'}, {'measure': 'Flow patterns', 'timeFrame': 'Time of MRI scan', 'description': 'Secondary outcome of 4D flow MRI'}, {'measure': 'Oscillatory shear index', 'timeFrame': 'Time of MRI scan', 'description': 'Secondary outcome of 4D flow MRI'}, {'measure': 'Reverse reflux rate constant (kep)', 'timeFrame': 'Time of MRI scan', 'description': 'Secondary outcome of DCE-MRI'}, {'measure': 'Area under the curve of contrast uptake', 'timeFrame': 'Time of MRI scan', 'description': 'Secondary outcome of DCE-MRI'}, {'measure': 'Peak enhancement ratio', 'timeFrame': 'Time of MRI scan', 'description': 'Secondary outcome of DCE-MRI'}, {'measure': 'Wash-in slope', 'timeFrame': 'Time of MRI scan', 'description': 'Secondary outcome of DCE-MRI'}, {'measure': 'Time to peak (TTP)', 'timeFrame': 'Time of MRI scan', 'description': 'Secondary outcome of DCE-MRI'}, {'measure': 'Mean transit time (MTT)', 'timeFrame': 'Time of MRI scan', 'description': 'Secondary outcome of DCE-MRI'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Abdominal Aortic Aneurysm', '4D flow MRI', 'DCE-MRI', 'T1 and T2 mapping'], 'conditions': ['Abdominal Aortic Aneurysm']}, 'descriptionModule': {'briefSummary': 'This study aims to determine whether advanced MRI sequences can provide robust and clinically relevant information about abdominal aortic aneurysms (AAAs). The MRI sequences will study outcomes related to blood flow inside AAA, microvasculature of the AAA vessel wall and intraluminal thrombus inside AAA.\n\nRobustness of these MRI sequences will be determined with testing of feasibility and reproducibility. Clinical relevance will be assessed by studying the association between the primary outcomes and disease severity. Disease severity will be expressed by AAA diameter.\n\nIt is our hypothesis that these parameters are significantly related to disease severity and may therefore be future markers of disease progression.', 'detailedDescription': 'This prospective study evaluates the feasibility, reproducibility and clinical relevance of MRI sequences in adults with an abdominal aortic aneurysm (AAA).\n\nThe MRI sequences and their primary outcomes are:\n\n* Four-dimensional (4D) flow MRI and wall shear stress (WSS)\n* Dynamic Contrast-Enhanced (DCE) MRI and kinetic transport constant (Ktrans)\n* T1 and T2 mapping (T1 and T2 relaxation times)\n\nFeasibility is tested by the production of high-quality images that enable calculation of the primary outcomes. Reproducibility is tested by calculating interscan, intra- and interobserver variability. Clinical relevance is tested by assessing the association between primary outcomes and disease severity which is expressed by AAA diameter'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with an abdominal aortic aneurysms who are patients at the department of vascular surgery of the Academic Medical Center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (≥ 18 years of age)\n* Abdominal aortic aneurysm with a maximal aneurysm diameter of at least 30 mm\n\nExclusion Criteria:\n\n* Contra-indications for MRI\n* Severely reduced renal function (eGFR \\< 30)\n* Previous allergic reaction to intravenous contrast agents\n* Suprarenal AAA\n* Pararenal AAA\n* Previous aneurysm repair\n* Inflammatory aneurysm\n* Mycotic or other infectious aneurysm\n* Vasculitis\n* Connective tissue disease'}, 'identificationModule': {'nctId': 'NCT03138434', 'briefTitle': 'Advanced MRI in AAA', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Advanced MRI in AAA', 'orgStudyIdInfo': {'id': 'NL56823.018.16'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Optimization phase', 'description': 'The first five patients will be included for the optimization of the MRI sequences. This is to ensure that a standard protocol will work for different sizes of AAA. These patients will only be scanned once.'}, {'label': 'Study phase', 'description': 'This phase will commence after the optimization phase. This phase is where we want to assess the feasibility, reproducibility and association with disease severity between MRI parameters and AAA.\n\nThese twenty patients will be scanned twice, with an interval of 1 week ± 5 days.\n\nThe study will be completed when we have 20 patients with 2 scans for each sequence, or when a maximum number of 30 patients in the study phase have been scanned.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Department of Vascular Surgery', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Ron Balm, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ron Balm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'prof. dr.', 'investigatorFullName': 'Ron Balm', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}