Temporal artery biopsy vs ultrasound in diagnosis of giant cell arteritis

Completed

• Conditions: Giant Cell Arteritis (GCA); Musculoskeletal Diseases; Other giant cell arteritis

• Registration Number: ISRCTN46280267
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-06
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 445

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 C-reactive protein (CRP) or erythrocyte sedimentation rate (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 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 inpatient 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 (>20 mg 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 (>20 mg per day at any time) steroids for conditions other than polymyalgia rheumatica (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 scan of the temporal and axillary arteries

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To evaluate the diagnostic accuracy (sensitivity and specificity) of ultrasound as an alternative to temporal artery biopsy for the diagnosis of GCA in patients referred for biopsy with suspected GCA (method: ultrasound scan and TAB, time point: six months) <br>2. To evaluate the cost-effectiveness (incremental cost per QALY) of ultrasound instead of biopsy in the diagnosis of GCA (time point: six months)

Secondary Outcome Measures

Name	Time	Method
1. To evaluate inter-observer agreement in the assessment of ultrasound and temporal artery biopsy (time frame: six months)<br>2. To elicit expert views on the appropriateness of performing a biopsy following ultrasound using clinical vignettes (time frame: three years)<br>3. To evaluate the diagnostic accuracy (sensitivity and specificity) of the sequential diagnostic strategy from 4 as an alternative to temporal artery biopsy alone in the diagnosis of GCA (time frame: three years)<br>4. To evaluate the cost-effectiveness (incremental cost per QALY) of the diagnostic strategy from 4 instead of biopsy alone in the diagnosis of GCA (time frame: three years)