Clinical Trials Directory

Trials / Completed

CompletedNCT03917680

Evaluation of New Markers in Type 3 Angioedema

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
32 (actual)
Sponsor
Brugmann University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTFactor XII dosageFactor 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.
GENETICp.Thr328Lys mutation detectionSequencing of exon 9 of franking introns of FXII, for identification of the p.Thr328Lys mutation.
DIAGNOSTIC_TESTVideocapillaroscopyIt is an optical method to visualize the most superficial part of the cutaneous microcirculatory network. It provides morphological information.

Timeline

Start date
2018-10-29
Primary completion
2019-10-08
Completion
2019-10-08
First posted
2019-04-17
Last updated
2020-01-18

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03917680. Inclusion in this directory is not an endorsement.