Characterization of Rhythmicity Profiles of Bradykinin-mediated Angioedema Attacks Using a Tracking Smartphone Application.

• Conditions: Bradykinin-mediated Angioedema
• Interventions: Other: Questionnaire on a smartphone application

• Registration Number: NCT05304091
• Lead Sponsor: University Hospital, Lille

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-24
• Study First Submitted QC: 2022-03-21
• Last Update Submitted: 2022-03-21
• Study First Posted: 2022-03-31
• Last Update Posted: 2022-03-31
• Study Start: 2022-08
• Primary Completion: 2023-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with bradykinin-mediated angioedema	Questionnaire on a smartphone application	Patients with bradykinin-mediated angioedema, aged 18 years or older, followed in the internal medicine department of the Lille University Hospital

Primary Outcome Measures

Name	Time	Method
Average number of bradykinin-mediated angioedema attacks	Follow up during 1 year

Secondary Outcome Measures

Name	Time	Method
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	Descriptif between patient's characteristics ( age, sex, disease onset and treatments) and Individual attack rhythmicity measures(secondary outcome measures n°2) Coefficients (with 95% intervals and Wald test p-values) and pseudo-R² of a Poisson regression modeling the individual number of crisis based on age, sex, disease onset and treatments.
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	Number of stable clusters of patients that may be drawn out of the data based on attack rhythmicity measures (based on the number of attacks, the average duration of an attack episode, and the average duration between two attacks) and characteristics of these clusters (mean and standard deviation of rhythmicity measures) in each and every cluster.; Stability and information metrics grounding the choice of the number of clusters and their analysis: * Bootstrapped Jaccard stability index of clusters, and its 95% confidence interval; * Silhouette value of the clustering; * Share of intra-cluster variance
Type of attack triggering events	After a year of follow up	In the application ,question is : "In the 48 hours preceding the onset of the crisis, did you identify one or more of the following events? (several answers possible) Multiple choice can be one or more between Physical activity; Local trauma (blow, injury ...); Dental or surgical procedure; Psychological stress or emotion; Infection; Periods / menstruation; Medication; Other (specify).