Clinical Trial: Magnetic Resonance Angiography vs Ultrasonography in Systemic Large vEssel vasculitiS

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

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.

Detailed Summary:

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.

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
Sponsor: Hospital of Southern Norway Trust

Current Primary Outcome: Accuracy of CDUS vs MRA in the assessment of the IMC thickness of the supra-aortic vessels in patients with sLVV. [ Time Frame: 12 months ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Measurement of the the average IMC thickness of aorta, carotid, subclavian, vertebral, axillary and temporal arteries in a population of healthy individuals. [ Time Frame: 12 months ]
    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.
  • Cellular, cytokine and genetic abnormalities in sLVV patients compared to the control group of healthy individuals [ Time Frame: 12 months ]


Original Secondary Outcome: Same as current

Information By: Hospital of Southern Norway Trust

Dates:
Date Received: December 27, 2013
Date Started: December 2013
Date Completion:
Last Updated: February 21, 2016
Last Verified: February 2016