跳至主要内容
临床试验/NCT05304091
NCT05304091撤回不适用

Rhythmicity Profiles of Bradykinin-mediated Angioedema.

University Hospital, Lille0 个研究点目标入组 100 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
100
主要终点
Average number of bradykinin-mediated angioedema attacks

研究概览

简要总结

Bradykinin-mediated angioedema is a rare and disabling disease, characterized by the occurrence of attacks marked by localized swelling of skin, but also of the airways, which can be life-threatening. The unpredictable nature of attacks is a key feature of angioedema, placing patients under constant threat. It seems that there are different patterns of yearly distribution for these attacks, but this is poorly described in the literature. The objectives of the study are to establish different rhythmicity profiles of patients according to the frequency of the attacks; and to identify factors potentially triggering the attacks. For this purpose, patients with bradykinin-mediated angioedema will be monitored daily using a smartphone application. Each day, the application will ask the patient if he or she is having an attack and, if so, the characteristics of the attack and the events preceding it

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

入选标准

  • Diagnosis of bradykinin-mediated angioedema
  • Age > 18
  • Having a smartphone
  • Non opposition to answer the questionnaire

排除标准

  • Patients with other type (histaminergic) angioedema
  • Patient unable or unwilling to use a smartphone application
  • Opposition to the research
  • Minor or protected adult
  • Person deprived of liberty

结局指标

主要结局

Average number of bradykinin-mediated angioedema attacks

时间窗: Follow up during 1 year

次要结局

  • The average duration between two attacks(Follow up during 1 year)
  • The average number of attack by time of year (months, seasons)(Follow up during 1 year)
  • The average duration of an attack episode(Follow up during 1 year)
  • Individual number of crisis(After a year of follow up)
  • Number of stable clusters of patients that may be drawn out of the data based on attack rhythmicity measures and characteristics of these clusters in each and every cluster.(After a year of follow up)
  • Type of attack triggering events(After a year of follow up)

研究者

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

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