HAS GCA V 4.3
Research type
Research Study
Full title
Halo Score (Temporal artery, its branches and Axillary artery) as a diagnostic, prognostic and disease monitoring tool for Giant Cell Arteritis (GCA.
IRAS ID
264294
Contact name
BHASKAR DASGUPTA
Contact email
Sponsor organisation
R&D Southend University hospital
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Giant cell arteritis (GCA) is a common large vessel vasculitis of the elderly, often associated with sight loss. Steroids remain mainstay of treatment, although biologic treatments have recently been approved. Biomarkers predicting disease severity, relapse rates and damage are lacking in GCA.
EULAR recommends ultrasound (US) as the first investigation for suspected GCA and ultrasound -based fast track clinics (FTC) help to promptly diagnose GCA, reduce sight loss and unnecessary steroids in mimics. The cardinal US finding, a non-compressible halo, is currently categorized as either negative or positive. However, the extent and severity of this finding may vary.
In this study, we hypothesise whether the extent and severity of the halo sign [calculated as a single composite Halo score (HS)] of temporal and axillary arteries may be of diagnostic, prognostic and monitoring importance; whether baseline HS is linked to disease outcomes, relapses and damage; whether HS can stratify GCA patients for individual treatment needs; whether HS can function as an objective monitoring tool during follow up.
Suspected GCA Participants will be selected at the time of referral to FTC at participating centres in the UK. Informed consent will be obtained and patients managed as part of standard care. Non-GCA patients will be discharged back to the referral team.
Patients will have HS (temporal and axillary arteries) measured at months 1,3,6 and 12. At these time points, in addition to routine clinical assessments and blood sampling, patient-reported outcomes (EQ5D) and research blood samples for biomarkers will also be obtained.
We aim to recruit 272 suspected GCA referrals which should yield 68 patients (25% of referrals) with confirmed GCA. The recruitment will be completed in one year with estimated total study period of 24 months. The study is funded by the Bresnihan Molloy Fellowship awarded by the RCPI for 24 months.
REC name
London - Stanmore Research Ethics Committee
REC reference
19/LO/1375
Date of REC Opinion
22 Aug 2019
REC opinion
Further Information Favourable Opinion