An observational study in ANGIOEDEMA, sponsored by University Hospital, Grenoble. Recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2021-11-01.
Sponsored by University Hospital, Grenoble · Observational
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.
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.
69 studies on the registry are indexed under Angioedema; 16 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 181 across 19 observational studies indexed under Angioedema.
Browse Angioedema studies →University Hospital, Grenoble is the lead sponsor of 837 studies on the registry; 207 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Any patient with isolated angioedema without associated wheals
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Hereditary angioedema with C1Inh deficiency
Behavioral: angioedema
Angioedema with acquired C1Inh deficiency
Behavioral: angioedema
Angioedema associated with ACEi used
Behavioral: angioedema
Spontaneous mast cell induced isolated angioedema
Behavioral: angioedema
Hereditary angioedema with normal C1Inh and with F12, PLG, ANGPT2 mutations
Behavioral: angioedema
electronic tracking book
Demographic patient data
Sexe and age of patient
Time frame: 5 years
Clinical characteristics
summary of patient visit report
Time frame: 5 years
Comorbidity
additional diseases
Time frame: 5 years
Angioedema diagnosis
type of angiodema
Time frame: 5 years
Angioedema diagnosis
position of genetic mutation if applicable
Time frame: 5 years
Angioedema diagnosis
biology marker : C1inh, C4, C1q, anti C1inh
Time frame: 5 years
Angioedema diagnosis
family history
Time frame: 5 years
Duration and severity of acute angioedema events
start date
Time frame: 5 years
Duration and severity of acute angioedema events
localization
Time frame: 5 years
Duration and severity of acute angioedema events
time before treatment
Time frame: 5 years
Duration and severity of acute angioedema events
time to resolution
Time frame: 5 years
Duration and severity of acute angioedema events
need access to hospital
Time frame: 5 years
Treatments used in managing the acute angioedema event
name
Time frame: 5 years
Treatments used in managing the acute angioedema event
dose
Time frame: 5 years
Treatments used in managing the acute angioedema event
date and time of acute treatment
Time frame: 5 years
Treatments used in the prophylaxis of angioedema
name
Time frame: 5 years
Treatments used in the prophylaxis of angioedema
dose
Time frame: 5 years
Treatments used in the prophylaxis of angioedema
start date
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
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