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
| Type | Name | Description |
|---|---|---|
| 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. |
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.