Evaluation of New Markers (FXII and Videocapillaroscopy) in Type 3 Angioedema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Plasma concentration of Factor XII
研究概览
简要总结
Angioedema is a common condition, with multiple etiologies.
Type 3 angioedema is caused by an increase in kininogenase activity responsible for an increased production of bradykinin. In some cases, it may be associated with clotting factor 12 mutations. However, other genetic abnormalities remain to be identified.
Clinically, this angioedema type 3 is similar to types 1 and 2. The patient's vital prognosis is good if the diagnosis is made and if they have access to the appropriate treatment. Otherwise a significant morbidity is associated with it, hence the importance of being able to define a diagnostic marker.
Videocapillaroscopy might be able to highlight abnormalities in the microcirculation of patients with a clinical display of angioedema.
The purpose of this study is to highlight markers allowing to make an early diagnosis of angioedema. Functional analysis of factor XII in patients with symptoms of angioedema may be an interesting marker for diagnosis.
Microcirculation abnormalities will also be evaluated by videocapillaroscopy, which may be another indicator of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Population of patients treated within the CHU Brugmann Hospital for an angioedema (and control group of healthy individuals)
排除标准
- 未提供
结局指标
主要结局
Plasma concentration of Factor XII
时间窗: 24 hours
Plasma concentration of Factor XII
Presence of p.Thr328Lys mutation
时间窗: 24 hours
Genetic analysis : sequencing of the Factor VII gene. Presence/Absence of the p.Thr328Lys mutation (single nucleotide variation inducing a missense variant).
Videocapillaroscopy result
时间窗: 24 hours
It is an optical method to visualize the most superficial part of the cutaneous microcirculatory network. It provides morphological information.The result will be classified as 'normal' or 'abnormal' by the videocapillaroscopy specialist.
次要结局
未报告次要终点
研究者
Olivier Michel
Head of immuno-allergology clinic
Brugmann University Hospital