NCT02523625|Unknown
Giant Cell Arteritis: Improving Use of Ultrasound Evaluation
GAULT
Can we Use Ultrasound in the Diagnosis and Monitoring of Patients With Giant Cell Arteritis?
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GAULT
Can we Use Ultrasound in the Diagnosis and Monitoring of Patients With Giant Cell Arteritis?
Sponsor study identifier
observational
250
0 countries
N/A
Study Start
October 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 4, 2015
Actual (reported)August 14, 2015
Actual (reported)October 2015
Date type not reportedThis date has not been verified as actual or estimated.
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Circulating serum Vascular Endothelial Growth Factor (VEGF) levels
24 months
Circulating serum Pentraxin 3 levels
24 months
Age and gender matched to patient groups to undergo ultrasound of temporal and axillary arteries
Patients with new headache not due to GCA to undergo ultrasound of temporal and axillary arteries
Patients with new diagnosis of GCA to undergo ultrasound of temporal and axillary arteries
Patients with apparent flare of GCA to undergo ultrasound of temporal and axillary arteries
Each patient will have a clinical assessment and ultrasound examination of both temporal and axillary arteries
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with suspected or diagnosed giant cell arteritis
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.
Serum Plasma Whole blood
Raashid A Luqmani, DM FRCP
University of Oxford
First Submitted
August 4, 2015
First Posted
August 14, 2015
Study Start
October 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2017
Estimated (date passed)Validation of a Diagnostic Algorithm of Giant Cell Arteritis
Contact the study team to confirm eligibility.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 14, 2015
Record last verified: 2015-08
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