open access publication

Article, 2024

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

Frontiers in Medicine, ISSN 2296-858X, Volume 11, Page 1415076, 10.3389/fmed.2024.1415076

Contributors

Nielsen, Berit Dalsgaard 0000-0001-6291-157X (Corresponding author) [1] [2] [3] Kristensen, Salome [4] [5] Donskov, Agnete Overgaard 0000-0002-7909-1624 [2] [3] Terslev, Lene [6] [7] Dreyer, Lene Wohlfahrt 0000-0002-5156-2922 [4] [5] Colic, Ada 0009-0008-7788-1797 [8] Hetland, Merete Lund 0000-0003-4229-6818 [6] [7] Højgaard, Pil 0000-0002-8046-263X [9] Ellingsen, Torkell Juulsgaard 0000-0003-0426-4962 [10] Hauge, Ellen-Margrethe [2] [3] Chrysidis, Stavros [10] Keller, Kresten Krarup 0000-0003-2474-3389 [2] [3]

Affiliations

  1. [1] Regional Hospital Horsens
    2. [NORA names: Central Denmark Region; Hospital; Denmark; Europe, EU; Nordic; OECD];
  2. [2] Aarhus University
    3. [NORA names: AU Aarhus University; University; Denmark; Europe, EU; Nordic; OECD];
  3. [3] Aarhus University Hospital
    4. [NORA names: Central Denmark Region; Hospital; Denmark; Europe, EU; Nordic; OECD];
  4. [4] Aalborg University
    5. [NORA names: AAU Aalborg University; University; Denmark; Europe, EU; Nordic; OECD];
  5. [5] Aalborg University Hospital
    6. [NORA names: North Denmark Region; Hospital; Denmark; Europe, EU; Nordic; OECD];

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.

Keywords

Biobank, Danish, Denmark, adverse events, aneurysm, aneurysm development, arteritis, biobank material, clinical data, clinical studies, cohort study, complications, comprehensive real-world data, cross-linking data, data, department, development, diagnosis, diagnostic imaging modalities, disease, disease duration, disease severity, disease spectrum, disease stratification, duration, effect, events, giant cell arteritis, giant cell arteritis patients, image stratification, images, imaging modalities, incidence, infrastructure, involvement, key objectives, large-vessel, large-vessel involvement, management, management strategies, materials, modalities, multicenter prospective study, multicenter study, national multicenter prospective study, national multicenter study, nationwide registries, objective, patients, polymyalgia, polymyalgia rheumatica, polymyalgia rheumatica patients, prevalent patients, prognostic role, project, prospective study, protocol, real-world data, registry, requirements, research, research protocol, rheumatology, rheumatology department, role, severity, spectra, strategies, stratification, study, treatment, treatment effects, treatment requirements

Funders

  • AbbVie (United States)
  • Gigtforeningen

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