Angio EdemaNCT03917680
Evaluation of New Markers in Type 3 Angioedema
A study testing Factor XII dosage, p.Thr328Lys mutation detection and Videocapillaroscopy in people with Angio Edema, run by Brugmann University Hospital at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Angio Edema
- What is being tested?
- Factor XII dosage, p.Thr328Lys mutation detection and Videocapillaroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Oct 2018to 8 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Population of patients treated within the CHU Brugmann Hospital for an angioedema (and control group of healthy individuals)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of New Markers (FXII and Videocapillaroscopy) in Type 3 Angioedema
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.
Read more
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
- Angio Edema
- Being tested
- Factor XII dosage, p.Thr328Lys mutation detection, Videocapillaroscopy
- Medical subject headings
- Angioedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Factor XII dosageDiagnostic test
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.
p.Thr328Lys mutation detectionGenetic
Sequencing of exon 9 of franking introns of FXII, for identification of the p.Thr328Lys mutation.
VideocapillaroscopyDiagnostic test
It is an optical method to visualize the most superficial part of the cutaneous microcirculatory network. It provides morphological information.
| Study group | Role | What they receive |
|---|---|---|
| Type III angioedema | Experimental | White angioedema. Positive for Factor XII mutation. No C1-inhibitors anomaly. Not caused by IEC. Receives: Diagnostic Test: Factor XII dosage; Genetic: p.Thr328Lys mutation detection; Diagnostic Test: Videocapillaroscopy |
| Idiopathic angioedema | Experimental | White angioedema. Negative for Factor XII mutation. No C1-inhibitors anomaly. Not caused by IEC. Receives: Diagnostic Test: Factor XII dosage; Genetic: p.Thr328Lys mutation detection; Diagnostic Test: Videocapillaroscopy |
| Type I or II angioedema | Experimental | White angioedema. Negative for Factor XII mutation. C1-inhibitors anomaly. Not caused by IEC. Receives: Diagnostic Test: Factor XII dosage; Genetic: p.Thr328Lys mutation detection; Diagnostic Test: Videocapillaroscopy |
| Post IEC (conversion enzyme inhibitors) angioedema | Experimental | White angioedema. Negative for Factor XII mutation. No C1-inhibitors anomaly. Caused by IEC. Receives: Diagnostic Test: Factor XII dosage; Genetic: p.Thr328Lys mutation detection; Diagnostic Test: Videocapillaroscopy |
| Histaminic angioedema | Experimental | Red angioedema.Negative for Factor XII mutation. No C1-inhibitors anomaly. Not caused by IEC. Receives: Diagnostic Test: Factor XII dosage; Genetic: p.Thr328Lys mutation detection; Diagnostic Test: Videocapillaroscopy |
| Control | Other | Healthy individuals, no angioedema. Receives: Diagnostic Test: Videocapillaroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of Factor XII
Plasma concentration of Factor XII
Measured: 24 hours
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).
Measured: 24 hours
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start29 Oct 2018
- Primary completion8 Oct 2019
- Study completion8 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angio EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Michel, Brugmann University Hospital
- Investigators
- Oumnia Mouna, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917680
- Sponsor's protocol ID
- CHUB-angiodema
- Status last verified
- Jan 2020
- First submitted
- 3 Apr 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of New Markers (FXII and Videocapillaroscopy) in Type 3 Angioedema
- ClinicalTrials.gov ID
- NCT03917680
- Acronym / sponsor ID
- CHUB-angiodema
- Conditions
- Angio Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 8 Oct 2019 (actual)
- Study completion
- 8 Oct 2019 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Type III angioedema | Experimental | Diagnostic Test: Factor XII dosage, Genetic: p.Thr328Lys mutation detection, Diagnostic Test: VideocapillaroscopyWhite angioedema. Positive for Factor XII mutation. No C1-inhibitors anomaly. Not caused by IEC. |
| Idiopathic angioedema | Experimental | Diagnostic Test: Factor XII dosage, Genetic: p.Thr328Lys mutation detection, Diagnostic Test: VideocapillaroscopyWhite angioedema. Negative for Factor XII mutation. No C1-inhibitors anomaly. Not caused by IEC. |
| Type I or II angioedema | Experimental | Diagnostic Test: Factor XII dosage, Genetic: p.Thr328Lys mutation detection, Diagnostic Test: VideocapillaroscopyWhite angioedema. Negative for Factor XII mutation. C1-inhibitors anomaly. Not caused by IEC. |
| Post IEC (conversion enzyme inhibitors) angioedema | Experimental | Diagnostic Test: Factor XII dosage, Genetic: p.Thr328Lys mutation detection, Diagnostic Test: VideocapillaroscopyWhite angioedema. Negative for Factor XII mutation. No C1-inhibitors anomaly. Caused by IEC. |
| Histaminic angioedema | Experimental | Diagnostic Test: Factor XII dosage, Genetic: p.Thr328Lys mutation detection, Diagnostic Test: VideocapillaroscopyRed angioedema.Negative for Factor XII mutation. No C1-inhibitors anomaly. Not caused by IEC. |
| Control | Other | Diagnostic Test: VideocapillaroscopyHealthy individuals, no angioedema. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Population of patients treated within the CHU Brugmann Hospital for an angioedema (and control group of healthy individuals)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Factor 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. | Diagnostic test | Histaminic angioedema, Idiopathic angioedema, Post IEC (conversion enzyme inhibitors) angioedema, Type I or II angioedema, Type III angioedema |
| p.Thr328Lys mutation detectionSequencing of exon 9 of franking introns of FXII, for identification of the p.Thr328Lys mutation. | Genetic | Histaminic angioedema, Idiopathic angioedema, Post IEC (conversion enzyme inhibitors) angioedema, Type I or II angioedema, Type III angioedema |
| VideocapillaroscopyIt is an optical method to visualize the most superficial part of the cutaneous microcirculatory network. It provides morphological information. | Diagnostic test | Control, Histaminic angioedema, Idiopathic angioedema, Post IEC (conversion enzyme inhibitors) angioedema, Type I or II angioedema, Type III angioedema |
Primary outcome
Plasma concentration of Factor XII
Time frame: 24 hours
Plasma concentration of Factor XII
Presence of p.Thr328Lys mutation
Time frame: 24 hours
Genetic analysis : sequencing of the Factor VII gene. Presence/Absence of the p.Thr328Lys mutation (single nucleotide variation inducing a missense variant).
Videocapillaroscopy result
Time frame: 24 hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oumnia Mouna, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Factor XII dosage, p.Thr328Lys mutation detection and Videocapillaroscopy in people with Angio Edema, run by Brugmann University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentration of Factor XII (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.