DANIsh血管炎队列研究,DANIVAS,是一项观察性的国家多中心研究,其总体目标是从丹麦风湿病科诊断和/或随访的风湿性多肌痛(PMR)和巨细胞动脉炎(GCA)患者中前瞻性地收集原型化的临床数据和生物库材料。长期的关键目标是研究使用新的临床实施的诊断成像方式是否有助于GCA-PMR疾病谱中的疾病分层。特别是,我们的目标是评估有和没有大血管受累的GCA患者的治疗要求,有和没有亚临床巨细胞动脉炎的PMR患者的治疗需求,以及影像学对动脉瘤发展的预后作用。因此,在GCA和PMR中,假设影像分层能够指导管理策略。在丹麦建立了风湿病学临床研究的基础设施,丹麦风湿病生物库的基础设施,以及将数据与有效的全国注册管理机构交叉链接的可能性,DANIVAS项目具有收集有关诊断的全面实际数据的特殊可能性,疾病严重程度,疾病持续时间,治疗效果,并发症,和不良事件。在本文中,我们提出了DANIVAS研究的研究方案.临床试验注册:https://clinicaltrials.gov/,标识符NCT05935709。
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.