Magnetic Resonance Angiography vs Ultrasonography in Systemic Large vEssel vasculitiS

NCT02042092 | Completed

• 1 other identifier: SNT-2013/1655
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Systemic Vasculitis

Keywords

Ultrasound; MRA; Large Vessel Vasculitis; Giant Cell Arteritis; Takayasu Arteritis; Immunological abnormalities

Outcome Measures

Primary Outcomes (1)

• Accuracy of CDUS vs MRA in the assessment of the IMC thickness of the supra-aortic vessels in patients with sLVV.

  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.

  12 months

Secondary Outcomes (2)

• Measurement of the the average IMC thickness of aorta, carotid, subclavian, vertebral, axillary and temporal arteries in a population of healthy individuals.

  12 months

• Cellular, cytokine and genetic abnormalities in sLVV patients compared to the control group of healthy individuals

  12 months

Study Arms (2)

Color Doppler Ultrasound (CDUS)

ACTIVE COMPARATOR

The aorta, supraaortic large vessels and the temporal arteries of the sLVV patients will be evaluated by color Doppler ultrasound

Device: Ultrasound

Magnetic resonance angiography (MRA)

ACTIVE COMPARATOR

The aorta, supraaortic large vessels and the temporal arteries of the sLVV patients will be evaluated by Magnetic resonance angiography

Device: MRA

Interventions

Ultrasound DEVICE

Color Doppler Ultrasound (CDUS)

MRA DEVICE

Magnetic resonance angiography (MRA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>18 years
• 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
• Fulfill the classification criteria for Giant Cell Arteritis /Takayasu Arteritis

You may not qualify if:

• Patients \<18 years
• Moderate to severe kidney failure
• Known allergic reactions to contrast agents
• Inability to give informed consent

Sponsors & Collaborators

• Hospital of Southern Norway Trust: lead
• Medical Center for Rheumatology Berlin-Buch: collaborator
• University of Freiburg: collaborator
• University Medical Center Groningen: collaborator

Study Sites (2)

Haugesund Sanitetsforenings Revmatismesykehus

Haugesund, 5504, Norway

Location

Department of Rheumatology, Hospital of Southern Norway Trust

Kristiansand, 4604, Norway

Location

Related Publications (8)

• 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: 11723761 BACKGROUND

• 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: 22267328 BACKGROUND

• 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: 15604899 BACKGROUND

• 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: 19077714 BACKGROUND

• 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: 22328740 BACKGROUND

• 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: 18077499 BACKGROUND

• 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: 10665744 BACKGROUND

• 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.

  PMID: 18668559 BACKGROUND

MeSH Terms

Conditions

Systemic Vasculitis; Giant Cell Arteritis; Takayasu Arteritis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Arteritis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Aortic Arch Syndromes; Aortic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Andreas Diamantopoulos, MD

  Departement of Rheumatology, Hospital of Southern Norway Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Rheumatologist

Study Record Dates

• First Submitted: December 27, 2013
• First Posted: January 22, 2014
• Study Start: December 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 23, 2016

Record last verified: 2016-02

Locations

NO (2)