Giant Cell Arteritis: Improving Use of Ultrasound Evaluation
NCT ID: NCT02523625
Last Updated: 2015-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
250 participants
OBSERVATIONAL
2015-10-31
2018-06-30
Brief Summary
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Detailed Description
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* Project Purpose:
The purpose of the project is to develop the technology to reliably acquire and analyse ultrasound images through the use of a training programme which are comparable to those from scanning by an expert sonographer in the diagnosis (i.e. as a diagnostic tool) and monitoring of patients with GCA following treatment (i.e. as a response indicator), and patient stratification according to initial or early scan changes to determine the most appropriate treatment (i.e. as a prognostic tool).
* End Point:
The end point will be the production of an effective training programme which can be used to obtain reproducible accurate ultrasound images of the temporal artery which can be automatically analysed and used in real time in the management of patients with suspected or confirmed giant cell arteritis.
* Milestones:
The project is in 3 phases. In phase 1 (0-12 months) the study group will create a bank of images for training from healthy volunteers and patients with GCA; in phase 2 (13-18 months) the study group will test the programme on sonographers assessing patients with GCA; in phase 3 (19-42 months) the study group will acquire serial images, clinical data, serum and plasma from cohorts of patients with newly diagnosed and flaring GCA so that they can analyse and develop new software algorithms. The study group can use images already acquired from a previous diagnostic study in GCA, and test the algorithms on the new cohorts..
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy volunteers
Age and gender matched to patient groups to undergo ultrasound of temporal and axillary arteries
Ultrasound of temporal and axillary arteries
Each patient will have a clinical assessment and ultrasound examination of both temporal and axillary arteries
Patients with headache
Patients with new headache not due to GCA to undergo ultrasound of temporal and axillary arteries
Ultrasound of temporal and axillary arteries
Each patient will have a clinical assessment and ultrasound examination of both temporal and axillary arteries
Patients with GCA (new)
Patients with new diagnosis of GCA to undergo ultrasound of temporal and axillary arteries
Ultrasound of temporal and axillary arteries
Each patient will have a clinical assessment and ultrasound examination of both temporal and axillary arteries
Patients with GCA (flare)
Patients with apparent flare of GCA to undergo ultrasound of temporal and axillary arteries
Ultrasound of temporal and axillary arteries
Each patient will have a clinical assessment and ultrasound examination of both temporal and axillary arteries
Interventions
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Ultrasound of temporal and axillary arteries
Each patient will have a clinical assessment and ultrasound examination of both temporal and axillary arteries
Eligibility Criteria
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Inclusion Criteria
* Patient with a suspected diagnosis of GCA but found not to have GCA
* Recent diagnosis of GCA within 1 month or
* Suspected flare of GCA within one month
* Ability to provide written informed consent
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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University of Lisbon
OTHER
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Raashid A Luqmani, DM FRCP
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Central Contacts
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References
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Ponte C, Rodrigues AF, O'Neill L, Luqmani RA. Giant cell arteritis: Current treatment and management. World J Clin Cases. 2015 Jun 16;3(6):484-94. doi: 10.12998/wjcc.v3.i6.484.
Diamantopoulos AP, Myklebust G. Long-term inflammation in the temporal artery of a giant cell arteritis patient as detected by ultrasound. Ther Adv Musculoskelet Dis. 2014 Jun;6(3):102-3. doi: 10.1177/1759720X14521109. No abstract available.
Schmidt WA. Ultrasound in vasculitis. Clin Exp Rheumatol. 2014 Jan-Feb;32(1 Suppl 80):S71-7. Epub 2014 Feb 17.
Diamantopoulos AP, Haugeberg G, Hetland H, Soldal DM, Bie R, Myklebust G. Diagnostic value of color Doppler ultrasonography of temporal arteries and large vessels in giant cell arteritis: a consecutive case series. Arthritis Care Res (Hoboken). 2014 Jan;66(1):113-9. doi: 10.1002/acr.22178.
Muratore F, Boiardi L, Restuccia G, Macchioni P, Pazzola G, Nicolini A, Germano G, Possemato N, Cavazza A, Cavuto S, Cimino L, Pipitone N, Catanoso M, Addimanda O, Salvarani C. Comparison between colour duplex sonography findings and different histological patterns of temporal artery. Rheumatology (Oxford). 2013 Dec;52(12):2268-74. doi: 10.1093/rheumatology/ket258. Epub 2013 Sep 17.
Habib HM, Essa AA, Hassan AA. Color duplex ultrasonography of temporal arteries: role in diagnosis and follow-up of suspected cases of temporal arteritis. Clin Rheumatol. 2012 Feb;31(2):231-7. doi: 10.1007/s10067-011-1808-0. Epub 2011 Jul 9.
Other Identifiers
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9776
Identifier Type: -
Identifier Source: org_study_id
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