The VGR GCA Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Sustained remission
研究概览
简要总结
Giant cell arteritis (GCA) is the most common vasculitis in the elderly and is usually treated with long-term corticosteroid therapy. Many patients experience relapses and treatment-related side effects. Current diagnostic and monitoring methods provide limited prognostic information and cannot reliably distinguish active from inactive disease during relapse. This project addresses the clinical need for improved tools to identify patients at high risk of relapse and to develop more effective methods for disease monitoring.
The aim is to develop new tools that enable more personalized treatment of GCA. By combining vascular ultrasound with novel blood biomarkers, we seek to predict disease course and relapse risk. The specific objectives are:
- To identify ultrasound and blood biomarkers that can predict long-term disease control.
- To determine which ultrasound parameters and blood biomarkers can distinguish active from inactive disease during treatment.
- To evaluate whether extended vascular ultrasound protocols can improve diagnostic accuracy.
The ultimate goal is to establish safe, practical tools for improved diagnosis and follow-up in patients with GCA.
详细描述
Background Giant cell arteritis (GCA) is the most common form of vasculitis in older adults and is characterized by inflammation of medium- and large-sized arteries. The disease can cause serious complications such as vision loss, aortic aneurysm, and stroke. Treatment is mainly based on long-term glucocorticoid therapy. Despite this, 30-60% of patients experience disease relapse during treatment, and many develop steroid-related side effects. There are substantial knowledge gaps regarding optimal treatment stratification, reliable differentiation between active inflammation and chronic vascular remodeling, and the ideal extent of vascular ultrasound examination for diagnostic accuracy.
Overall Aim and Specific Objectives The overarching aim of this study is to determine which ultrasound parameters and novel blood biomarkers have prognostic, monitoring, and diagnostic value in GCA. The goal is to enable more individualized therapy and to reduce the risk of both over- and undertreatment.
Specific objectives are:
- To identify ultrasound parameters and biomarkers with prognostic value for long-term treatment response.
- To identify ultrasound parameters and biomarkers that distinguish active from inactive inflammation during treatment and at diagnosis.
- To evaluate whether an extended vascular ultrasound protocol improves diagnostic accuracy compared with the current European (EULAR) recommendations, and to assess whether ultrasound-detected neovascularization corresponds to histological neovascularization in temporal artery biopsy specimens.
Current Research Context Diagnostic advances in GCA have recently been driven by imaging techniques, particularly ultrasound. The European Alliance of Associations for Rheumatology (EULAR) currently recommends ultrasound assessment of the temporal and axillary arteries in suspected GCA. Quantitative parameters such as intima-media thickness (IMT) and scoring systems (e.g., Halo count and the OMERACT GCA Ultrasonography Score, OGUS) are used to assess vascular wall inflammation. However, these methods primarily evaluate cranial arteries and the axillary arteries. Studies using PET-CT have shown that extracranial vascular involvement is common and associated with a higher relapse risk and longer treatment duration. We have previously developed an extended ultrasound protocol that includes a broader set of extracranial arteries. In a retrospective study, we demonstrated that this extended protocol improves diagnostic accuracy compared to the EULAR-recommended approach.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals referred for evaluation due to suspected giant cell arteritis (GCA).
- •Ability to provide written informed consent.
排除标准
- •Previous diagnosis of GCA.
- •Previous temporal artery biopsy performed as part of prior GCA evaluation.
- •Treatment with high-dose corticosteroids (>7.5 mg/day) for more than two weeks before initiation of the diagnostic work-up.
- •Inability to provide informed consent.
- •Inability to comply with the study protocol.
研究组 & 干预措施
GCA group
Individuals diagnosed with GCA
Control group
Individuals not diagnosed with GCA
结局指标
主要结局
Sustained remission
时间窗: 12 months
Defined as achievement of a daily glucocorticoid dose of ≤5 mg after 12 months of standardized treatment according to the treatment protocol recommended by the Swedish Society for Rheumatology. Primary Objective: To determine which ultrasound parameters and novel biomarkers, individually and as a composite measure (intima-media thickness \[IMT\] + morphological neovascularization), have prognostic value for remission and relapse in patients with giant cell arteritis (GCA). Primary Hypotheses: 1a. The composite measure (IMT + morphological neovascularization) predicts remission at 12 months more accurately than each individual parameter or previously established ultrasound metrics. 1b. Clinically applicable threshold values exist for the composite measure and for selected biomarkers that distinguish patients achieving remission from those who do not.
次要结局
- Relapse(Up to 12 months)
- Final Diagnosis of GCA(6 months)