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Evaluation of New Markers in Type 3 Angioedema

Primary Purpose

Angio Edema

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Factor XII dosage
p.Thr328Lys mutation detection
Videocapillaroscopy
Sponsored by
Brugmann University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Angio Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • CHU Brugmann

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Other

Arm Label

Type III angioedema

Idiopathic angioedema

Type I or II angioedema

Post IEC (conversion enzyme inhibitors) angioedema

Histaminic angioedema

Control

Arm Description

White angioedema. Positive for Factor XII mutation. No C1-inhibitors anomaly. Not caused by IEC.

White angioedema. Negative for Factor XII mutation. No C1-inhibitors anomaly. Not caused by IEC.

White angioedema. Negative for Factor XII mutation. C1-inhibitors anomaly. Not caused by IEC.

White angioedema. Negative for Factor XII mutation. No C1-inhibitors anomaly. Caused by IEC.

Red angioedema.Negative for Factor XII mutation. No C1-inhibitors anomaly. Not caused by IEC.

Healthy individuals, no angioedema.

Outcomes

Primary Outcome Measures

Plasma concentration of Factor XII
Plasma concentration of Factor XII
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).
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.

Secondary Outcome Measures

Full Information

First Posted
April 3, 2019
Last Updated
January 15, 2020
Sponsor
Brugmann University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03917680
Brief Title
Evaluation of New Markers in Type 3 Angioedema
Official Title
Evaluation of New Markers (FXII and Videocapillaroscopy) in Type 3 Angioedema
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
October 8, 2019 (Actual)
Study Completion Date
October 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angio Edema

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Type III angioedema
Arm Type
Experimental
Arm Description
White angioedema. Positive for Factor XII mutation. No C1-inhibitors anomaly. Not caused by IEC.
Arm Title
Idiopathic angioedema
Arm Type
Experimental
Arm Description
White angioedema. Negative for Factor XII mutation. No C1-inhibitors anomaly. Not caused by IEC.
Arm Title
Type I or II angioedema
Arm Type
Experimental
Arm Description
White angioedema. Negative for Factor XII mutation. C1-inhibitors anomaly. Not caused by IEC.
Arm Title
Post IEC (conversion enzyme inhibitors) angioedema
Arm Type
Experimental
Arm Description
White angioedema. Negative for Factor XII mutation. No C1-inhibitors anomaly. Caused by IEC.
Arm Title
Histaminic angioedema
Arm Type
Experimental
Arm Description
Red angioedema.Negative for Factor XII mutation. No C1-inhibitors anomaly. Not caused by IEC.
Arm Title
Control
Arm Type
Other
Arm Description
Healthy individuals, no angioedema.
Intervention Type
Diagnostic Test
Intervention Name(s)
Factor XII dosage
Intervention Description
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.
Intervention Type
Genetic
Intervention Name(s)
p.Thr328Lys mutation detection
Intervention Description
Sequencing of exon 9 of franking introns of FXII, for identification of the p.Thr328Lys mutation.
Intervention Type
Diagnostic Test
Intervention Name(s)
Videocapillaroscopy
Intervention Description
It is an optical method to visualize the most superficial part of the cutaneous microcirculatory network. It provides morphological information.
Primary Outcome Measure Information:
Title
Plasma concentration of Factor XII
Description
Plasma concentration of Factor XII
Time Frame
24 hours
Title
Presence of p.Thr328Lys mutation
Description
Genetic analysis : sequencing of the Factor VII gene. Presence/Absence of the p.Thr328Lys mutation (single nucleotide variation inducing a missense variant).
Time Frame
24 hours
Title
Videocapillaroscopy result
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Population of patients treated within the CHU Brugmann Hospital for an angioedema (and control group of healthy individuals) Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oumnia Mouna, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brugmann
City
Brussel
ZIP/Postal Code
1020
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of New Markers in Type 3 Angioedema

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