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临床试验/NCT02833675
NCT02833675已完成不适用

Determination of Specific Biomarkers of Angioneurotic Crisis

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
VE CADHERIN SENSITIVITY AND SPECIFICITY

研究概览

简要总结

Diagnosis of angioedema (AE) is difficult especially in emergency room. Two forms should be evoked: histaminic AE (allergic or not, which represent 95% of cases) and bradykinic AE (hereditary or acquired deficiency, with or without C1 Inhibitor) rarer but with more severe prognosis. The distinction is based on clinical features (spontaneous crisis duration, presence of concomitant hives, atopic history...). Sometimes it could be difficult to make the difference. Nowadays, there is no biological marker of the crisis. The search for biomarkers could improve the diagnostic and therapeutic management of AE. Previous work has identified targets: D-dimer, C4, and VE-cadherin. We wanted to know the sensitivity and specificity of these markers.

We conducted a prospective study evaluating the D-dimer assays, complement and VE-cadherin during an episode of AE. Three groups of patients were tested: bradykinic AE (peripheral or abdominal attacks), histaminic AE, and abdominal pain (non-bradykinic and non-histaminic etiology) at the time (day 0) and at distance from the crisis (D7).

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • Histaminergic or bradykinin angioedema
  • Abdominal pain

排除标准

  • children < 18 years

结局指标

主要结局

VE CADHERIN SENSITIVITY AND SPECIFICITY

时间窗: 7 DAYS

次要结局

  • D-DIMERS SENSITIVITY AND SPECIFICITY(7 DAYS)
  • C1INHIBITOR(7 DAYS)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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