Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-03-01 @ 3:22 AM
Study NCT ID:
NCT02042092
Status:
COMPLETED
Last Update Posted:
2016-02-23
First Post:
2013-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Resonance Angiography vs Ultrasonography in Systemic Large vEssel vasculitiS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056647', 'term': 'Systemic Vasculitis'}, {'id': 'D013700', 'term': 'Giant Cell Arteritis'}, {'id': 'D013625', 'term': 'Takayasu Arteritis'}], 'ancestors': [{'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020293', 'term': 'Vasculitis, Central Nervous System'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D001167', 'term': 'Arteritis'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001015', 'term': 'Aortic Arch Syndromes'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-21', 'studyFirstSubmitDate': '2013-12-27', 'studyFirstSubmitQcDate': '2014-01-19', 'lastUpdatePostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of CDUS vs MRA in the assessment of the IMC thickness of the supra-aortic vessels in patients with sLVV.', 'timeFrame': '12 months', 'description': 'CDUS is superior to MRA in the assessment of the abnormal IMC of supraaortic vessels and temporal artery and comparable to MRA in the assessment of proximal thoracic and abdominal aorta.'}], 'secondaryOutcomes': [{'measure': 'Measurement of the the average IMC thickness of aorta, carotid, subclavian, vertebral, axillary and temporal arteries in a population of healthy individuals.', 'timeFrame': '12 months', 'description': 'An estimation of the average IMC thicknesses of aorta, carotid, subclavian, vertebral, axillary and temporal arteries in a population of healthy individuals by ultrasound and a comparison to those of patients with sLVV will be performed.'}, {'measure': 'Cellular, cytokine and genetic abnormalities in sLVV patients compared to the control group of healthy individuals', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ultrasound', 'MRA', 'Large Vessel Vasculitis', 'Giant Cell Arteritis', 'Takayasu Arteritis', 'Immunological abnormalities'], 'conditions': ['Systemic Vasculitis']}, 'referencesModule': {'references': [{'pmid': '11723761', 'type': 'BACKGROUND', 'citation': 'Gonzalez-Gay MA, Garcia-Porrua C. Epidemiology of the vasculitides. Rheum Dis Clin North Am. 2001 Nov;27(4):729-49. doi: 10.1016/s0889-857x(05)70232-5.'}, {'pmid': '22267328', 'type': 'BACKGROUND', 'citation': 'Prieto-Gonzalez S, Arguis P, Garcia-Martinez A, Espigol-Frigole G, Tavera-Bahillo I, Butjosa M, Sanchez M, Hernandez-Rodriguez J, Grau JM, Cid MC. Large vessel involvement in biopsy-proven giant cell arteritis: prospective study in 40 newly diagnosed patients using CT angiography. Ann Rheum Dis. 2012 Jul;71(7):1170-6. doi: 10.1136/annrheumdis-2011-200865. Epub 2012 Jan 20.'}, {'pmid': '15604899', 'type': 'BACKGROUND', 'citation': 'Schmidt WA, Blockmans D. Use of ultrasonography and positron emission tomography in the diagnosis and assessment of large-vessel vasculitis. Curr Opin Rheumatol. 2005 Jan;17(1):9-15. doi: 10.1097/01.bor.0000147282.02411.c6.'}, {'pmid': '19077714', 'type': 'BACKGROUND', 'citation': 'Blockmans D, Bley T, Schmidt W. Imaging for large-vessel vasculitis. Curr Opin Rheumatol. 2009 Jan;21(1):19-28. doi: 10.1097/BOR.0b013e32831cec7b.'}, {'pmid': '22328740', 'type': 'BACKGROUND', 'citation': "Grayson PC, Maksimowicz-McKinnon K, Clark TM, Tomasson G, Cuthbertson D, Carette S, Khalidi NA, Langford CA, Monach PA, Seo P, Warrington KJ, Ytterberg SR, Hoffman GS, Merkel PA; Vasculitis Clinical Research Consortium. Distribution of arterial lesions in Takayasu's arteritis and giant cell arteritis. Ann Rheum Dis. 2012 Aug;71(8):1329-34. doi: 10.1136/annrheumdis-2011-200795. Epub 2012 Feb 10."}, {'pmid': '18077499', 'type': 'BACKGROUND', 'citation': 'Schmidt WA, Seifert A, Gromnica-Ihle E, Krause A, Natusch A. Ultrasound of proximal upper extremity arteries to increase the diagnostic yield in large-vessel giant cell arteritis. Rheumatology (Oxford). 2008 Jan;47(1):96-101. doi: 10.1093/rheumatology/kem322.'}, {'pmid': '10665744', 'type': 'BACKGROUND', 'citation': 'Schmidt WA, Kraft HE, Borkowski A, Gromnica-Ihle EJ. Color duplex ultrasonography in large-vessel giant cell arteritis. Scand J Rheumatol. 1999;28(6):374-6. doi: 10.1080/03009749950155373.'}, {'pmid': '18668559', 'type': 'BACKGROUND', 'citation': 'Bley TA, Reinhard M, Hauenstein C, Markl M, Warnatz K, Hetzel A, Uhl M, Vaith P, Langer M. Comparison of duplex sonography and high-resolution magnetic resonance imaging in the diagnosis of giant cell (temporal) arteritis. Arthritis Rheum. 2008 Aug;58(8):2574-8. doi: 10.1002/art.23699.'}]}, 'descriptionModule': {'briefSummary': 'This study is a cross sectional comparison of the Color Doppler Ultrasonography (CDUS) and Magnetic Resonance Angiography (MRA) in patients diagnosed with sLVV. The supraaortic large vessels (aorta, carotid, subclavian, vertebral, and axillary arteries) and the temporal arteries of fifty patients suffering of sLVV will be examined by CDUS and MRA. The images will be evaluated by 2 blinded experts (one for CDUS and one for MRA). In addition, the intima media complex (IMC) thickness of the large vessels and temporal arteries will be measured by CDUS in 100 sex and age matched controls to the sLVV patients. Blood samples from patients and controls will be collected in order to perform genetic and cytokine analyses.', 'detailedDescription': 'The proposed cross sectional study will recruit 50 patients diagnosed with sLVV. All patients recruited to this study will be referrals from outpatient clinic of the Department of Rheumatology, Hospital of Southern Norway Trust. The diagnosis will be based on previous CDUS, MRA, CTA and/or biopsies of the temporal arteries. The patients will be classified according to specific set of classification criteria for GCA (11) or TA (12). The patients will undergo a CDUS evaluation of the supraaortic large vessels and the temporal arteries. In addition, a thorough clinical assessment will be performed at the CDUS visit. A blood sample to test the acute phase response (CRP and ESR) and other biochemical parameters as part of standard care will also be collected.\n\nWithin one week after the CDUS evaluation, MRA of the thoracic aorta, the supra-aortic vessels and temporal artery will be performed. The images of both examinations will be uploaded anonymously in a database and two external experts blinded to the patients (one for CDUS and one for MRA) will evaluate the data. The completed evaluation form will be uploaded in the same database.\n\nThe ultrasound examination will be performed by using high-end equipment, a Siemens S-2000 with a high, or medium frequency linear (up to 18 MHz for the superficial vessels or medium frequency up to 13 MHz for the deeper vessels) or phased-array transducer (examination of the aorta). The supraaortic vessels and the thoracic aorta will be evaluated by Gadolinium contrast-enhanced T1-weighted spin echo sequence with fat saturation 1.5 Tesla MRI equipment.\n\nIn both examinations, a measurement of the intima-media complex (IMC) thickness will be performed. The highest IMC thickness measurement will be recorded in both longitudinal and transverse films (of \\>3 sec length both in B and color Doppler mode for CDUS). Positive examination will be considered a measurement of IMC thickness \\>1.5 mm for aorta, carotid, subclavian and \\>1.0mm for the vertebral and axillary arteries. For the temporal artery, the presence of halo (circumferential, hypoechoic thickness of IMC in transverse/longitudinal view) will be considered as a positive finding. Stenoses of more than 50% in both modalities will also be recorded. Retrograde flow of the vertebral arteries in CDUS examination will be also considered as a positive finding.\n\nAdditionally, 100 healthy individuals matched for sex and age to the sLVV patients will be examined in their supraaortic large vessels and temporal arteries by CDUS. The IMC thickness of the healthy individuals will be measured by CDUS, the recordings will be labeled and stored in a database at the Department of Rheumatology, Hospital of Southern Norway Trust, in Kristiansand.\n\nThe CDUS and MRA images will be submitted to external experts for evaluation by using a specific evaluation form (Appendix). Both the experts will be blinded to the clinical, laboratory and previous imaging findings of the patients.\n\nIn addition, the level of inflammatory cytokines, chemokines and vascular markers (e.g. Vascular Endothelial Growth Factor (VEGF) and Metalloproteinase (MMP) -9) in blood samples of the patients with sLVV will be measured and compared to healthy controls. Whole blood, plasma and serum samples stored at -70 oC will be analyzed for expression of a panel of inflammatory cytokines by Enzyme-linked immunosorbent assay (ELISA) or related methods. Total RNA will be prepared from whole blood. All the blood samples will be stored in Revmabiobank at Hospital of Southern Norway Trust in Kristiansand.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients \\>18 years\n2. Diagnosis of large vessel vasculitis based on Ultrasonographic and/or Computed Tomography Angiography and/or Magnetic Resonance Angiography findings or biopsies of the temporal arteries\n3. Fulfill the classification criteria for Giant Cell Arteritis /Takayasu Arteritis\n\nExclusion Criteria:\n\n1. Patients \\<18 years\n2. Moderate to severe kidney failure\n3. Known allergic reactions to contrast agents\n4. Inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT02042092', 'acronym': 'MUSES', 'briefTitle': 'Magnetic Resonance Angiography vs Ultrasonography in Systemic Large vEssel vasculitiS', 'organization': {'class': 'OTHER', 'fullName': 'Hospital of Southern Norway Trust'}, 'officialTitle': 'A Head-to-Head Comparison of Color Doppler Ultrasonography (CDUS) and Magnetic Resonance Angiography (MRA) in Patients With Systemic Large Vessel Vasculitis (sLVV) - A Cross Sectional Study', 'orgStudyIdInfo': {'id': 'SNT-2013/1655'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Color Doppler Ultrasound (CDUS)', 'description': 'The aorta, supraaortic large vessels and the temporal arteries of the sLVV patients will be evaluated by color Doppler ultrasound', 'interventionNames': ['Device: Ultrasound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Magnetic resonance angiography (MRA)', 'description': 'The aorta, supraaortic large vessels and the temporal arteries of the sLVV patients will be evaluated by Magnetic resonance angiography', 'interventionNames': ['Device: MRA']}], 'interventions': [{'name': 'Ultrasound', 'type': 'DEVICE', 'armGroupLabels': ['Color Doppler Ultrasound (CDUS)']}, {'name': 'MRA', 'type': 'DEVICE', 'armGroupLabels': ['Magnetic resonance angiography (MRA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5504', 'city': 'Haugesund', 'country': 'Norway', 'facility': 'Haugesund Sanitetsforenings Revmatismesykehus', 'geoPoint': {'lat': 59.41378, 'lon': 5.268}}, {'zip': '4604', 'city': 'Kristiansand', 'country': 'Norway', 'facility': 'Department of Rheumatology, Hospital of Southern Norway Trust', 'geoPoint': {'lat': 58.14671, 'lon': 7.9956}}], 'overallOfficials': [{'name': 'Andreas Diamantopoulos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Departement of Rheumatology, Hospital of Southern Norway Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital of Southern Norway Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical Center for Rheumatology Berlin-Buch', 'class': 'UNKNOWN'}, {'name': 'University of Freiburg', 'class': 'OTHER'}, {'name': 'University Medical Center Groningen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Rheumatologist', 'investigatorFullName': 'Andreas P Diamantopoulos', 'investigatorAffiliation': 'Hospital of Southern Norway Trust'}}}}