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The DANIsh VASculitis cohort study: protocol for a national multicenter prospective study including incident and
Berit D Nielsen1,2,3, Salome Kristensen4,5, Agnete Donskov2,3
1Department of Medicine, The Regional Hospital in Horsens, Horsens, Denmark.
Insights
The DANIsh VASculitis (DANIVAS) study collects data on polymyalgia rheumatica (PMR) and giant cell arteritis (GCA). This research aims to improve disease stratification and guide management strategies using advanced imaging techniques.
Area of Science:
- Rheumatology
- Vasculitis Research
- Clinical Epidemiology
Background:
- Polymyalgia rheumatica (PMR) and giant cell arteritis (GCA) are common vasculitic diseases.
- Current diagnostic and stratification methods for PMR and GCA may be enhanced by advanced imaging.
- The DANIsh VASculitis (DANIVAS) cohort study was established to address these needs.
Purpose of the Study:
- To prospectively collect clinical data and biobank material from PMR and GCA patients.
- To investigate if new diagnostic imaging modalities can stratify disease within the GCA-PMR spectrum.
- To evaluate treatment requirements and prognostic factors, including aneurysm development, guided by imaging.
Main Methods:
- Observational, national, multicenter study design.
- Prospective collection of protocolized clinical data and biobank samples.
- Utilizing established Danish rheumatology infrastructure and nationwide registries for data linkage.
Main Results:
- This paper presents the research protocol for the DANIVAS study.
- The study is designed to collect comprehensive real-world data on diagnosis, disease severity, treatment, and complications.
- The infrastructure allows for robust data analysis and linkage with national registries.
Conclusions:
- The DANIVAS project offers a unique opportunity to gather extensive real-world data on GCA and PMR.
- Imaging stratification is hypothesized to guide management strategies for GCA and PMR patients.
- The study protocol is presented, laying the groundwork for future findings on vasculitis management.
Abstract:
The DANIsh VASculitis cohort study, DANIVAS, is an observational national multicenter study with the overall aim to prospectively collect protocolized clinical data and biobank material from patients with polymyalgia rheumatica (PMR) and giant cell arteritis (GCA) diagnosed and/or followed at Danish rheumatology departments. A long-term key objective is to investigate whether the use of new clinically implemented diagnostic imaging modalities facilitates disease stratification in the GCA-PMR disease spectrum. In particular, we aim to evaluate treatment requirements in GCA patients with and without large-vessel involvement, treatment needs in PMR patients with and without subclinical giant cell arteritis, and the prognostic role of imaging with respect to aneurysm development. Hence, in GCA and PMR, imaging stratification is hypothesized to be able to guide management strategies. With an established infrastructure within rheumatology for clinical studies in Denmark, the infrastructure of the Danish Rheumatologic Biobank, and the possibility to cross-link data with valid nationwide registries, the DANIVAS project holds an exceptional possibility to collect comprehensive real-world data on diagnosis, disease severity, disease duration, treatment effect, complications, and adverse events. In this paper, we present the research protocol for the DANIVAS study. Clinical trial registration: https://clinicaltrials.gov/, identifier NCT05935709.
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