NCT03845946

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
28mo left

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Sep 2018Sep 2028

Study Start

First participant enrolled

September 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

10 years

First QC Date

January 8, 2019

Last Update Submit

October 29, 2021

Conditions

ANGIOEDEMA

Outcome Measures

Primary Outcomes (18)

  • Demographic patient data

    Sexe and age of patient

    5 years

  • Clinical characteristics

    summary of patient visit report

    5 years

  • Comorbidity

    additional diseases

    5 years

  • Angioedema diagnosis

    type of angiodema

    5 years

  • Angioedema diagnosis

    position of genetic mutation if applicable

    5 years

  • Angioedema diagnosis

    biology marker : C1inh, C4, C1q, anti C1inh

    5 years

  • Angioedema diagnosis

    family history

    5 years

  • Duration and severity of acute angioedema events

    start date

    5 years

  • Duration and severity of acute angioedema events

    localization

    5 years

  • Duration and severity of acute angioedema events

    time before treatment

    5 years

  • Duration and severity of acute angioedema events

    time to resolution

    5 years

  • Duration and severity of acute angioedema events

    need access to hospital

    5 years

  • Treatments used in managing the acute angioedema event

    name

    5 years

  • Treatments used in managing the acute angioedema event

    dose

    5 years

  • Treatments used in managing the acute angioedema event

    date and time of acute treatment

    5 years

  • Treatments used in the prophylaxis of angioedema

    name

    5 years

  • Treatments used in the prophylaxis of angioedema

    dose

    5 years

  • Treatments used in the prophylaxis of angioedema

    start date

    5 years

Study Arms (5)

Hereditary angioedema type I/II

Hereditary angioedema with C1Inh deficiency

Behavioral: angioedema

Acquired angioedema

Angioedema with acquired C1Inh deficiency

Behavioral: angioedema

Drug induced angioedema

Angioedema associated with ACEi used

Behavioral: angioedema

Mast cell induced angioedema

Spontaneous mast cell induced isolated angioedema

Behavioral: angioedema

Hereditary angioedema with nC1Inh

Hereditary angioedema with normal C1Inh and with F12, PLG, ANGPT2 mutations

Behavioral: angioedema

Interventions

angioedemaBEHAVIORAL

electronic tracking book

Acquired angioedemaDrug induced angioedemaHereditary angioedema type I/IIHereditary angioedema with nC1InhMast cell induced angioedema

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient with isolated angioedema without associated wheals

You may qualify if:

  • 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)

You may not qualify if:

  • Patient unable to give consent.
  • Wheals with angioedema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Grenoble

Grenoble, Isere, 38043, France

RECRUITING

MeSH Terms

Conditions

Angioedema

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesUrticariaSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • laurence bouillet

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Central Study Contacts

laurence bouilelt, MD, PhD

CONTACT

+33476765565lbouillet@chu-grenoble.fr

Isabelle Boccon-Gibod

CONTACT

+3347676767640iboccon-gibod@chu-grenoble.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2019

First Posted

February 19, 2019

Study Start

September 1, 2018

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

November 1, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)