Magnetic Resonance Angiography vs Ultrasonography in Systemic Large vEssel vasculitiS
NCT ID: NCT02042092
Last Updated: 2016-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2013-12-31
2015-12-31
Brief Summary
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Detailed Description
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Within 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.
The 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.
In 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.
Additionally, 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.
The 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.
In 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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Color Doppler Ultrasound (CDUS)
The aorta, supraaortic large vessels and the temporal arteries of the sLVV patients will be evaluated by color Doppler ultrasound
Ultrasound
Magnetic resonance angiography (MRA)
The aorta, supraaortic large vessels and the temporal arteries of the sLVV patients will be evaluated by Magnetic resonance angiography
MRA
Interventions
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Ultrasound
MRA
Eligibility Criteria
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Inclusion Criteria
2. 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
3. Fulfill the classification criteria for Giant Cell Arteritis /Takayasu Arteritis
Exclusion Criteria
2. Moderate to severe kidney failure
3. Known allergic reactions to contrast agents
4. Inability to give informed consent
18 Years
ALL
Yes
Sponsors
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Medical Center for Rheumatology Berlin-Buch
UNKNOWN
University of Freiburg
OTHER
University Medical Center Groningen
OTHER
Hospital of Southern Norway Trust
OTHER
Responsible Party
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Andreas P Diamantopoulos
Consultant Rheumatologist
Principal Investigators
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Andreas Diamantopoulos, MD
Role: PRINCIPAL_INVESTIGATOR
Departement of Rheumatology, Hospital of Southern Norway Trust
Locations
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Haugesund Sanitetsforenings Revmatismesykehus
Haugesund, , Norway
Department of Rheumatology, Hospital of Southern Norway Trust
Kristiansand, , Norway
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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SNT-2013/1655
Identifier Type: -
Identifier Source: org_study_id
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