Clinical trial: Temporal Artery Biopsy vs ULtrasound in Diagnosis of GCA (TABUL) (NCT00974883)

Eligibility criteria:
Inclusion Criteria: for the cohort study

          1. A clinical suspicion of new diagnosis of GCA e.g. patients with a new onset of
             headache, scalp tenderness, with or without elevated CRP or ESR, jaw or tongue
             claudication with or without visual loss.

          2. The clinician decides that the patient requires an urgent temporal artery biopsy to
             determine whether or not the diagnosis is GCA.

          3. The patient agrees and provides NHS consent to undergo a temporal artery biopsy as
             part of standard care.

          4. Patients have been started on high dose glucocorticoids or will be started on high
             dose glucocorticoids.

          5. Patients must be willing to attend for an ultrasound scan of their temporal and
             axillary arteries.

          6. Participants must be willing to give informed written consent or willing to give
             permission for a nominated friend or relative to provide written informed assent if
             they are unable to do so because of physical disabilities e.g. sudden onset of
             blindness/vision loss which can be caused by GCA (this will be made clear in the
             ethics approval application).

          7. Must be 18 years of age or over.

        For the training cases

          1. Patients attending hospital outpatient or in patient departments for assessment for
             any condition (apart from giant cell arteritis or polymyalgia rheumatica) or healthy
             staff volunteers.

          2. Above the age of 50 years.

          3. Willing to attend for an ultrasound scan of their temporal and axillary arteries.

          4. Willing and able to give written informed consent.

        Exclusion criteria: for the cohort study

          1. Previous diagnosis of GCA.

          2. Use of high dose glucocorticoid (>20mg prednisolone/day) for management of current
             suspected GCA for more than 7 days prior to the dates of the ultrasound and biopsy.

          3. Long term (>1 month) high dose (>20mg per day at any time) steroids for conditions
             other than PMR, within three months prior to study entry.

          4. Inability to give informed consent (either written consent or verbal assent from a
             relative or carer)

          5. Inability to undergo an ultrasound scans of the temporal and axillary arteries.

          6. Patients with a known cause of headache (not due to GCA), or any condition which would
             preclude the need for a temporal artery biopsy.

          7. Patients who are unable to undergo an ultrasound scan and a temporal artery biopsy
             within 7 days of starting glucocorticoids.

        For the training cases

          1. Diagnosis of suspected GCA or a previous history of diagnosed or suspected GCA.

          2. Inability to give written informed consent.

          3. Inability to undergo an ultrasound scans of the temporal and axillary arteries
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 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? Contradiction