Clinical trial: Evaluation of Ultrasound and PET/CT in the Diagnosis and Monitoring of Giant Cell Arteritis (NCT03765424)

Eligibility criteria:
Inclusion Criteria:

          1. Age more than 50 years

          2. C-reactive protein (CRP)>15 mg/L or erythrocyte sedimentation rate (ESR)>40 mm/h

          3. Either

               1. cranial symptoms such as new-onset headache or scalp tenderness, jaw or tongue
                  claudication, visual disturbances

               2. new-onset limb claudication

               3. protracted constitutional symptoms, defined as weight loss>5 kilograms or
                  fever>38 degrees Celcius for >3 weeks

               4. Bilateral shoulder pain and morning stiffness.

        Exclusion Criteria:

          1. oral glucocorticoid treatment within the past month;

          2. subcutaneous, intramuscular, intra-articular or intravenous glucocorticoid within the
             past 2 months;

          3. DMARD treatment or other immunosuppressive therapy within the past 3 months;

          4. ongoing treatment with interleukin2;

          5. previous diagnosis of GCA or polymyalgia rheumatica;

          6. 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.


Patient description (medical language): A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing.  He also complains of fatigue and hip muscle aches over the last several months.  The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications.  On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min.  Neurological examination is unremarkable.  Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation.

Patient description (patient's own words): I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage.

Does the patient match the trial criteria? Entailment