NCT07084480招募中不适用
Riesenzellarteriitis - Wege Zur "Precision Medicine"
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Incidence of aortic adverse events
研究概览
简要总结
Long-term follow-up of aortal adverse events, as well as glucocortioid-associated adverse events in patients with polymyalgia rheumatica (PMR) and giant cell arteritis (GCA).
详细描述
In this non-interventional cohort study the following aspects should be addressed:
- Can regular imaging procedures help to better assess the risk of aortic aneurysms and dissections over a period of 5-10 years after initial diagnosis of GCA?
- Which prognostic factors correlate with aortic events?
- What conclusions can be drawn about glucocorticoid-associated side effects over the longer (5-year) course?
- Can modern imaging in correlation with standardized clinical examination, serological markers and immunophenotypic testing define patient clusters within the clinically heterogeneous disease spectrum of GCA and PMR with the aim of individualizing therapy?
- What is the value of orbital MRI together with an ophthalmologic examination including fudoscopy and optical coherence tomography (OCT) in the detection of ischemic manifestations of GCA?
- Can a contrast agent-saving MRI technique (with 25 % less contrast agent) be used in GCA without impairing signal quality?
- Can rare lymphocyte populations be found by immunophenotyping, which provide information on the probability of recurrence or allow therapy control?
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
- 否
入选标准
- •Age greater or similar to 18 years
- •Primary diagnosis of GCA or PMR
排除标准
- •Age under 18 years
- •lack of capacity to consent
结局指标
主要结局
Incidence of aortic adverse events
时间窗: Within 5 years
Aortic adverse events include new foramation or progress of aortic aneurysms, and aortic dissection
次要结局
- Incidence of glucocorticoid-related adverse events(within 5 years)
- Detection of ischemic complications in the eyes(within 5 years)
- Performance of gadopiclenol in detecting vessel wall inflammation(within 5 years)
研究者
研究点 (1)
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