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Health Condition(s) or Problem
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Giant Cell Arteritis
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Lay Summary
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Giant Cell Arteritis (GCA) causes inflammation and narrowing of blood vessels and can cause
blindness in one third of patients. It is important that a prompt, accurate diagnosis of GCA
is made and treatment given as steroids for two or more years. Currently there is no 100%
accurate test for GCA. Patients usually have new headache and scalp tenderness, typically
with an abnormal blood test. However, it can be difficult to distinguish non-serious forms
of headache from GCA; infection produces similar abnormal blood results. If there is a
suspicion of GCA, treatment with steroids is started straight away. To confirm a diagnosis,
the patient will need a biopsy of a temporal artery (a minor procedure performed under
local anaesthetic to remove a sample of one of the scalp arteries). However, up to 44% of
patients will have a normal biopsy. Therefore it is difficult to know if a patient with a
normal biopsy does or does not have GCA. Withdrawing steroid treatment may increase the risk
of blindness. Continuing treatment in a patient without GCA increases the risk of side
effects (e.g., weight gain, infection risk, osteoporosis and fracture risk, high blood
pressure, diabetes, cataracts). It is important to improve diagnostic tests for GCA. Another
test to help in diagnosing GCA is an ultrasound scan of the arteries in the side of the head
and under the arms. Ultrasound does not involve surgery; it is a simple test which can be
performed as an out patient. Gel is applied to both sides of the head and under each arm.
A sound probe is placed over the artery at each site to produce the scan.
The investigators' study will examine the role of ultrasound in diagnosis of 402 patients
with suspected GCA. All patients will have an ultrasound examination in addition to biopsy
within a week of starting steroids. Patients will be treated according to usual practice.
After six months, the investigators will reassess the diagnosis. The investigators will
look at the accuracy of ultrasound compared with or combined with biopsy. The investigators
will look at how a doctor's knowledge of ultrasound results or biopsy results alone would
affect the diagnosis and recommendation to continue or stop steroid treatment. The
investigators will assess whether knowledge of both results together would alter the
diagnosis and treatment. The investigators will collect information to estimate the costs
of different ways of diagnosing GCA in relation to the impact on quality of life.
(from ClinicalTrials.gov)
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Who can enter the trial
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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
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Who cannot enter the trial
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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
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What will happen
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Procedure; Ultrasound of temporal and axillary arteries; Standardised assessment of temporal arteries and axillary arteries using high resolution ultrasound to detect halo, stenosis or occlusion; Suspected GCA; Training cohort; ultrasound scan; Procedure; Temporal artery biopsy; Biopsy of temporal artery from symptomatic side; Suspected GCA; biopsy of temporal artery
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Primary aim
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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.; To evaluate the cost-effectiveness (incremental cost per QALY) of ultrasound instead of biopsy in the diagnosis of GCA.
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Secondary Aim
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To evaluate inter-observer agreement in the assessment of ultrasound and temporal artery biopsy; Six months; No; To elicit expert views on the appropriateness of performing a biopsy following ultrasound using clinical vignettes; 3 years; No; To evaluate the diagnostic accuracy (sensitivity and specificity) of the sequential diagnostic strategy as an alternative to temporal artery biopsy alone in the diagnosis of GCA; 3 years; No; To evaluate the cost-effectiveness (incremental cost per QALY) of the diagnostic strategy of combined ultrasound and biopsy instead of biopsy alone in the diagnosis of GCA.; 3 years; No; Specific adverse events measured at each assessment; daily and cumulative steroid dose; steroid side effects; and pain or dysaesthesia at the biopsy site.; Six months; Yes; Evolution of an alternative diagnosis; Six months; No; Negative predictive value of ultrasound in preventing the need for temporal artery biopsies.; Six months; No; Cost analysis of performing a screening ultrasound examination plus biopsy as part of the diagnostic workup of all patients with suspected GCA; or of performing a screening ultrasound examination instead of biopsy; or of performing a screening ultrasound; Six months; No; Cost analysis of performing a screening ultrasound examination instead of biopsy in cases with a very low probability of GCA as part of the diagnostic workup of all patients with suspected GCA.; 3 years; No; Prediction of potential harm done to patients by over diagnosis or under diagnosis of GCA as a result of ultrasound use, either alone or in combination with biopsy; 3 years; Yes; Value of axillary artery ultrasound scanning in contributing to the diagnosis of GCA.; Six months; No; Analysis of proportion of patients with a biopsy positive halo, stenosis, or occlusion assessed by high resolution ultrasound; 3 years; No; Presence of characteristic features of GCA on temporal artery biopsy in relation to clinical and ultrasound findings; 2 weeks; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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http://www.ndorms.ox.ac.uk/clinicaltrials.php?trial=tabul; https://weblearn.ox.ac.uk/portal/hierarchy/medsci/department/ndorms/tabul
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Recruitment Status
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Recruiting
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Nation
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England, Scotland, Northern Ireland
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Location
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Oxford, Aberdeen, Aylesbury, Belfast, Birmingham, Bury St. Edmunds, Cambridge, Chesterfield, Thornton Heath, Derby, Dudley, Camberley, Gateshead, Glasgow, Great Yarmouth, Hampshire , Harlow, Ipswich, Tunbridge Wells, Leeds, Liverpool, London, Manchester, Middlesbrough, Newcastle upon Tyne, Northampton, Norwich, Nottingham, Salisbury, Rochdale, Poole, Portsmouth, Reading, Romford, Sheffield, Southampton, Southend-on-Sea, Cannock, Stoke-on-Trent, Sunderland
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