Status:
COMPLETED
Evaluation of Ultrasound and PET/CT in the Diagnosis and Monitoring of Giant Cell Arteritis
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
The Danish Rheumatism Association
Hartmann Fonden
Conditions:
Giant Cell Arteritis
Vasculitis
Eligibility:
All Genders
50+ years
Brief Summary
The aim of this project is to prospectively evaluate the diagnostic accuracy of different imaging tools in specific giant cell arteritis disease subsets before and after treatment initiation. Diagnost...
Detailed Description
The diagnosis of GCA is clinical and syndrome-based. Only few years ago, temporal artery biopsy (TAB) was the standard diagnostic tool to confirm diagnosis, although sensitivity is moderate\[3,4\] and...
Eligibility Criteria
Inclusion
- Age more than 50 years
- C-reactive protein (CRP)\>15 mg/L or erythrocyte sedimentation rate (ESR)\>40 mm/h
- Either
- cranial symptoms such as new-onset headache or scalp tenderness, jaw or tongue claudication, visual disturbances
- new-onset limb claudication
- protracted constitutional symptoms, defined as weight loss\>5 kilograms or fever\>38 degrees Celcius for \>3 weeks
- Bilateral shoulder pain and morning stiffness.
Exclusion
- oral glucocorticoid treatment within the past month;
- subcutaneous, intramuscular, intra-articular or intravenous glucocorticoid within the past 2 months;
- DMARD treatment or other immunosuppressive therapy within the past 3 months;
- ongoing treatment with interleukin2;
- previous diagnosis of GCA or polymyalgia rheumatica;
- any disease potentially causing large vessel inflammation, that is autoimmune diseases; rheumatoid arthritis, Cogans syndrome, relapsing polychondritis, ankylosing spondylitis, systemic lupus erythematosus, Buerger's disease, Bechet's disease, inflammatory bowel disease, infections; syphilis, known active current or history of recurrent tuberculosis, hepatitis or HIV, or other large vessel disease; sarcoidosis, neurofibromatosis, congenital coarctation, Marfans syndrome, Ehlers-Danlos syndrome, retroperitoneal fibrosis.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT03765424
Start Date
October 1 2014
End Date
December 31 2018
Last Update
October 4 2021
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