TY - JOUR

T1 - The DANIsh VASculitis cohort study

T2 - protocol for a national multicenter prospective study including incident and prevalent patients with giant cell arteritis and polymyalgia rheumatica

AU - Nielsen, Berit D.

AU - Kristensen, Salome

AU - Donskov, Agnete

AU - Terslev, Lene

AU - Dreyer, Lene Wohlfahrt

AU - Colic, Ada

AU - Hetland, Merete Lund

AU - Højgaard, Pil

AU - Ellingsen, Torkell

AU - Hauge, Ellen Margrethe

AU - Chrysidis, Stavros

AU - Keller, Kresten K.

N1 - Publisher Copyright: Copyright © 2024 Nielsen, Kristensen, Donskov, Terslev, Dreyer, Colic, Hetland, Højgaard, Ellingsen, Hauge, Chrysidis and Keller.

PY - 2024

Y1 - 2024

N2 - 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.

AB - 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.

KW - cohort study (or longitudinal study)

KW - giant cell arteritis

KW - imaging

KW - polymyalgia rheumatica

KW - prognosis

KW - prospective observational study

U2 - 10.3389/fmed.2024.1415076

DO - 10.3389/fmed.2024.1415076

M3 - Journal article

C2 - 39026552

AN - SCOPUS:85198637447

VL - 11

JO - Frontiers in Medicine

JF - Frontiers in Medicine

SN - 2296-858X

M1 - 1415076

ER -