Clinical prediction rule and high resolution sonography for the diagnosis of cranial giant cell arteritis: prospective validation study

Recruiting

• Conditions: M31.6; Other giant cell arteritis

• Registration Number: DRKS00031293
• Lead Sponsor: udwig-Maximilians-Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Reasonable clinical suspicion of GCA
- Signed consent form

Exclusion Criteria

-Age < 50 years
-Absence of reasonable clinical suspicion of GCA
-Pre-existing diagnosis of GCA
-Delay between initiation of empirical glucocorticoid therapy with > 20 mg/d prednisolone equivalent and completion of the study study of > 7 days
- Pre-existing therapy with glucocorticoids with a daily dose of > 20 mg for at least 30 days within the past 3 months
-Pre-existing therapy with the interleukin-6 receptor antagonist tocilizumab
- Lack of consent

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of the negative and positive predictive value of a diagnostic algorithm based on the combination of a novel clinical prediction rule, a sensitive biomarker (c-reactice protein) and high resolution sonography sonography for the exclusion or diagnosis of GCA, compared to the final clinical reference diagnosis based on an extensive combined diagnostic workup including temporal artery biopsy.

Secondary Outcome Measures

Name	Time	Method
- Determination of the diagnostic value of high-resolution sonography of the temporal arteries in comparison with methods compared to temporal biopsy and 18FDG-PET-CT. <br>- Assessment of the additional diagnostic benefit of sonographic examination of the facial and axillary arteries in the diagnosis of GCA. <br>- Gender comparison and risk-adapted stratification of cut-off values of high-resolution sonography of the temporal and facial arteries. <br>- Analysis of the influence of the clinical pre-test probability on the diagnostic quality of high-resolution sonography of the temporal arteries and other imaging techniques. <br>-Analysis of the influence of empirical steroid therapy on the diagnostic quality of the test procedures and the diagnostic algorithm used.