Combining vascular ultrasound and blood markers to improve diagnosis and monitoring of giant cell arteritis
The VGR GCA Cohort
This project will test whether adding extended ultrasound scans to new blood biomarkers can better predict relapse and tell active from inactive giant cell arteritis in people referred for suspected GCA.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 340 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT07246577 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort of patients referred for suspected giant cell arteritis who will undergo detailed vascular ultrasound and blood sampling for novel biomarkers. Investigators will compare an extended ultrasound protocol with standard ultrasound recommendations and correlate ultrasound findings with biomarker levels and clinical outcomes over time. The study aims to identify imaging and blood-based signatures that predict long-term disease control and distinguish active inflammation from chronic vascular changes. Results will be used to inform more individualized treatment strategies and reduce unnecessary prolonged steroid exposure.
Who should consider this trial
Good fit: Adults referred for evaluation of suspected GCA who can give written informed consent, with no prior GCA diagnosis or prior temporal artery biopsy and who have not received high‑dose corticosteroids (>7.5 mg/day) for more than two weeks before the diagnostic work-up.
Not a fit: People with a previous diagnosis of GCA, a prior temporal artery biopsy, or prolonged prior high‑dose steroid treatment are excluded and are unlikely to benefit from the study results.
Why it matters
Potential benefit: If successful, the approach could allow more personalized treatment plans that lower relapse rates and reduce steroid-related side effects.
How similar studies have performed: Vascular ultrasound is already used in GCA and prior studies show promise for some biomarkers, but combining an extended ultrasound protocol with novel blood biomarkers for prognostic and monitoring purposes is relatively new and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Individuals referred for evaluation due to suspected giant cell arteritis (GCA). * Ability to provide written informed consent. Exclusion Criteria * Previous diagnosis of GCA. * Previous temporal artery biopsy performed as part of prior GCA evaluation. * Treatment with high-dose corticosteroids (\>7.5 mg/day) for more than two weeks before initiation of the diagnostic work-up. * Inability to provide informed consent. * Inability to comply with the study protocol.
Where this trial is running
Gothenburg
- Sahlgrenska Universitetssjukhuset — Gothenburg, Sweden (Recruiting)
Study contacts
- Study coordinator: Johan Skoog, MD, PhD
- Email: johan.l.skoog@vgregion.se
- Phone: +46313421000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.