The DANIsh VASculitis cohort study: protocol for a national multicenter prospective study including incident and prevalent patients with giant cell arteritis and polymyalgia rheumatica

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  • Berit D. Nielsen
  • Salome Kristensen
  • Agnete Donskov
  • Terslev, Lene
  • Lene Wohlfahrt Dreyer
  • Ada Colic
  • Hetland, Merete Lund
  • Pil Højgaard
  • Torkell Ellingsen
  • Ellen Margrethe Hauge
  • Stavros Chrysidis
  • Kresten K. Keller

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.

Original languageEnglish
Article number1415076
JournalFrontiers in Medicine
Volume11
Number of pages11
ISSN2296-858X
DOIs
Publication statusPublished - 2024

Bibliographical note

Publisher Copyright:
Copyright © 2024 Nielsen, Kristensen, Donskov, Terslev, Dreyer, Colic, Hetland, Højgaard, Ellingsen, Hauge, Chrysidis and Keller.

    Research areas

  • cohort study (or longitudinal study), giant cell arteritis, imaging, polymyalgia rheumatica, prognosis, prospective observational study

ID: 399168451