Status:
COMPLETED
Temporal Artery Biopsy vs ULtrasound in Diagnosis of GCA (TABUL)
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
University of Sheffield
Mid and South Essex NHS Foundation Trust
Conditions:
Giant Cell Arteritis
Eligibility:
All Genders
18+ years
Brief Summary
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 tre...
Detailed Description
OVERALL DESIGN: The overall design consists of a cohort study of 402 participants with suspected GCA who will be followed up for 6 months; a cost-effectiveness study comparing ultrasound with temporal...
Eligibility Criteria
Inclusion
- Inclusion Criteria: for the cohort study
- 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.
- The clinician decides that the patient requires an urgent temporal artery biopsy to determine whether or not the diagnosis is GCA.
- The patient agrees and provides NHS consent to undergo a temporal artery biopsy as part of standard care.
- Patients have been started on high dose glucocorticoids or will be started on high dose glucocorticoids.
- Patients must be willing to attend for an ultrasound scan of their temporal and axillary arteries.
- 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).
- Must be 18 years of age or over.
- For the training cases
- 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.
- Above the age of 50 years.
- Willing to attend for an ultrasound scan of their temporal and axillary arteries.
- Willing and able to give written informed consent.
- Exclusion criteria: for the cohort study
- Previous diagnosis of GCA.
- 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.
- 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.
- Inability to give informed consent (either written consent or verbal assent from a relative or carer)
- Inability to undergo an ultrasound scans of the temporal and axillary arteries.
- Patients with a known cause of headache (not due to GCA), or any condition which would preclude the need for a temporal artery biopsy.
- Patients who are unable to undergo an ultrasound scan and a temporal artery biopsy within 7 days of starting glucocorticoids.
- For the training cases
- Diagnosis of suspected GCA or a previous history of diagnosed or suspected GCA.
- Inability to give written informed consent.
- Inability to undergo an ultrasound scans of the temporal and axillary arteries
Exclusion
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
880 Patients enrolled
Trial Details
Trial ID
NCT00974883
Start Date
June 1 2010
End Date
December 1 2014
Last Update
July 17 2015
Active Locations (27)
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1
Universitätsklinikum Jena
Jena, Germany, 07743 Jena
2
St Vincent's University Hospital
Dublin, Ireland, Dublin 4
3
Hospital of Southern Norway
Kristiansand, Norway, Post box 416, 4605
4
Hospital de Santa Maria
Lisbon, Portugal, 1649-035