Rhythmicity Profiles of Bradykinin-mediated Angioedema.
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
- 否
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)
