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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031293

Enrollment

150

Registered

2024-07-16

Start date

2023-05-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M31.6

Interventions

Group 1: Prospective, single-arm, observational study of patients (age 50 years or older) with suspected giant cell arteritis (GCA)

Eligibility

Sex/Gender

All

Age

50 Years to No maximum

Inclusion criteria

Inclusion criteria: - Reasonable clinical suspicion of GCA - Signed consent form

Exclusion criteria

Exclusion criteria: -Age 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
- 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. - Assessment of the additional diagnostic benefit of sonographic examination of the facial and axillary arteries in the diagnosis of GCA. - Gender comparison and risk-adapted stratification of cut-off values of high-resolution sonography of the temporal and facial arteries. - 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. -Analysis of the influence of empirical steroid therapy on the diagnostic quality of the test procedures and the diagnostic algorithm used.	—

Measure

Time frame

- 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. - Assessment of the additional diagnostic benefit of sonographic examination of the facial and axillary arteries in the diagnosis of GCA. - Gender comparison and risk-adapted stratification of cut-off values of high-resolution sonography of the temporal and facial arteries. - 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. -Analysis of the influence of empirical steroid therapy on the diagnostic quality of the test procedures and the diagnostic algorithm used.

—

Countries

Germany

Contacts

Public ContactMichael Czihal

Sektion Angiologie, Medizinische Klinik und Poliklinik IV, LMU München

michael.czihal@med.uni-muenchen.de089/4400-32642

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026