Giant Cell Arteritis Clinical Trial
— GAULTOfficial title:
Can we Use Ultrasound in the Diagnosis and Monitoring of Patients With Giant Cell Arteritis?
Giant cell arteritis (GCA) is an inflammatory disease causing new, unaccustomed headache in the elderly and which can lead to blindness in 20-30% of untreated cases. The study group have previously shown that ultrasound is a viable non-invasive alternative to temporal artery biopsy in diagnosing GCA. However, there is significant variation in ultrasound assessment (measuring a dark "halo" around the abnormal blood vessels) between sonographers in different centres, requiring a labour intensive and time consuming training programme. The study group propose to standardise the training programme, and use ultrasound and clinical evaluation to define changes occurring over time and with treatment in patients with a diagnosis of GCA made based on ultrasound changes alone. The study group will explore the use of algorithms to automate or semi-automate image interpretation.
Status | Not yet recruiting |
Enrollment | 250 |
Est. completion date | June 2018 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Healthy volunteer or - 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: - Unable to provide written informed consent |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Oxford | University of Lisbon |
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;6 — View Citation
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. — View Citation
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. — View Citation
Muratore F, Boiardi L, Restuccia G, Macchioni P, Pazzola G, Nicolini A, Germanò 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 histologica — View Citation
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. Review. — View Citation
Schmidt WA. Ultrasound in vasculitis. Clin Exp Rheumatol. 2014 Jan-Feb;32(1 Suppl 80):S71-7. Epub 2014 Feb 17. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Size of halo detected (mm) on ultrasound of temporal arteries | The study group will compare computer algorithms to analyse the halo size from video images of ultrasound scans with observer defined measures of halo size (mm) from healthy volunteers, patients with headache but not due to GCA, patients with newly diagnosed GCA and in patients with GCA who are followed serially and re-imaged over time in response to therapy. The study group will test the value of algorithms incorporating clinical and serological data together with the imaging findings to determine their added effect on the sensitivity and specificity of ultrasound for diagnosis and monitoring of GCA. Halo size varies from 0 (undetectable) to greater than 1mm. Cut-off values for abnormal values have not been formally established or published yet. | 24 months | No |
Secondary | Circulating serum Vascular Endothelial Growth Factor (VEGF) levels | The study group will measure VEGF levels in serum taken from age matched controls presenting with headache, patients with newly diagnosed GCA and patients with established GCA undergoing a flare, to determine the value of VEGF in predicting diagnosis, response to therapy, flare or prognosis in GCA. | 24 months | No |
Secondary | Circulating serum Pentraxin 3 levels | The study group will measure pentraxin 3 levels in serum taken from age matched controls presenting with headache, patients with newly diagnosed GCA and patients with established GCA undergoing a flare, to determine the value of pentraxin 3 in predicting diagnosis, response to therapy, flare or prognosis in GCA. | 24 months | No |
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