Evaluation of New Markers in Type 3 Angioedema

Angio Edema Clinical Trial

Official title:

Evaluation of New Markers (FXII and Videocapillaroscopy) in Type 3 Angioedema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03917680
• Other study ID #: CHUB-angiodema
• Status: Completed
• Phase: N/A
• Start date: October 29, 2018
• Est. completion date: October 8, 2019

Study information

• Verified date: January 2020
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Angioedema is a common condition, with multiple etiologies.

Type 3 angioedema is caused by an increase in kininogenase activity responsible for an increased production of bradykinin. In some cases, it may be associated with clotting factor 12 mutations. However, other genetic abnormalities remain to be identified.

Clinically, this angioedema type 3 is similar to types 1 and 2. The patient's vital prognosis is good if the diagnosis is made and if they have access to the appropriate treatment. Otherwise a significant morbidity is associated with it, hence the importance of being able to define a diagnostic marker.

Videocapillaroscopy might be able to highlight abnormalities in the microcirculation of patients with a clinical display of angioedema.

The purpose of this study is to highlight markers allowing to make an early diagnosis of angioedema. Functional analysis of factor XII in patients with symptoms of angioedema may be an interesting marker for diagnosis.

Microcirculation abnormalities will also be evaluated by videocapillaroscopy, which may be another indicator of the disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 8, 2019
• Est. primary completion date: October 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Population of patients treated within the CHU Brugmann Hospital for an angioedema (and control group of healthy individuals)

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Angio Edema
• Angioedema

Intervention

Diagnostic Test:
• Factor XII dosage
Factor XII (FXII, Hageman factor) will be measured in plasma. It is converted to FXIIa by an activator. The FXIIa protease cleaves a chromogenic substrate and releases p-nitroaniline (pNA), which can be measured photometrically.

Genetic:
• p.Thr328Lys mutation detection
Sequencing of exon 9 of franking introns of FXII, for identification of the p.Thr328Lys mutation.

Diagnostic Test:
• Videocapillaroscopy
It is an optical method to visualize the most superficial part of the cutaneous microcirculatory network. It provides morphological information.

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of Factor XII	Plasma concentration of Factor XII	24 hours
Primary	Presence of p.Thr328Lys mutation	Genetic analysis : sequencing of the Factor VII gene. Presence/Absence of the p.Thr328Lys mutation (single nucleotide variation inducing a missense variant).	24 hours
Primary	Videocapillaroscopy result	It is an optical method to visualize the most superficial part of the cutaneous microcirculatory network. It provides morphological information.The result will be classified as 'normal' or 'abnormal' by the videocapillaroscopy specialist.	24 hours