International Registry of Isolated Angioedema
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Demographic patient data
研究概览
简要总结
Angioedema is a disease characterized by the appearance of self-limiting edema that last 1-5 days and affect the subcutaneous tissue and/or gastrointestinal and oropharyngeal mucosa. In this last location edema can be lethal causing asphyxia, in all other cases full recovery is complete. Attacks can appear as part of the syndrome urticaria angioedema and can be of allergic origin. But there is a group of non-allergic angioedema that occur without hives and can be either hereditary or acquired. These angioedema are identified in some cases on the basis of etiology, in others are identified by the mediator and an overall classification of these forms of angioedema was published in 2014 as a result of a consent conference organized by the proponents of this registry. Being these forms of angioedema rare, there are not significative case studies inclusive of a high number of patients. This registry aims to collect in a single place a high number of subjects with recurring angioedema and without urticaria.
详细描述
The Grenoble center is the registry coordinator at the national level. It will contract directly with the Cloud R Company and will be in charge of coordinating the associated centers. It will therefore send the necessary documents for the good execution of the study, will ask each center to respect the current French regulatory, will organize and finance the set-up of the register in the associated centers.
The coordinating center will also centralize requests for data, publications or creation of additional eCRF pages of associated centers. It will be able to organize a national scientific committee every 6 months. It will thus be the link between the French centers, the scientific committee of the registry and the company Cloud R.
The coordinating center will also be responsible for enter and reliability of patient data from it center, as well as the associated centers.
Role of associated centers Associated Centers will be responsible for capturing and data reliability of their patients in eCRF, they will also create a personal account for each patient so that it can download the application "cloud R HAE carnet de suivi".
Investigators referent patient will have validated at each visit or after contact with the patient crisis returned to the patient via it electronic diary.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient with isolated angioedema without associated wheals.
- •Patients with hereditary angioedema with or without C1 deficiency.
- •Major patient with consent (signature)
- •Minor patient whose parents / legal guardians have given their consent (signature)
排除标准
- •Patient unable to give consent.
- •Wheals with angioedema
结局指标
主要结局
Demographic patient data
时间窗: 5 years
Sexe and age of patient
Comorbidity
时间窗: 5 years
additional diseases
Angioedema diagnosis
时间窗: 5 years
family history
Duration and severity of acute angioedema events
时间窗: 5 years
need access to hospital
Treatments used in the prophylaxis of angioedema
时间窗: 5 years
start date
Clinical characteristics
时间窗: 5 years
summary of patient visit report
Treatments used in managing the acute angioedema event
时间窗: 5 years
date and time of acute treatment
次要结局
未报告次要终点