Идёт набор NCT03845946

CLOUD-R HAE REGISTRY

— Наблюдательное ANGIOEDEMA

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: angioedema.
Кому может быть актуально: Состояния в реестре: ANGIOEDEMA. Базовые параметры: Без ограничений · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

International Registry of Isolated Angioedema

Обзор

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.

Подробное описание

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.

Associated Centers will keep informed twice a year the coordinator center of the state of inclusions in the register.

Вмешательства

Поведенческое angioedema
electronic tracking book

Первичные конечные точки

Demographic patient data [Срок оценки: 5 years]
Clinical characteristics [Срок оценки: 5 years]
Comorbidity [Срок оценки: 5 years]
Angioedema diagnosis [Срок оценки: 5 years]
Angioedema diagnosis [Срок оценки: 5 years]
Angioedema diagnosis [Срок оценки: 5 years]
Angioedema diagnosis [Срок оценки: 5 years]
Duration and severity of acute angioedema events [Срок оценки: 5 years]
Duration and severity of acute angioedema events [Срок оценки: 5 years]
Duration and severity of acute angioedema events [Срок оценки: 5 years]

Критерии участия

Критерии включения

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)