Determination of Specific Biomarkers of Acute Attack of Angioedema Within Pediatric Population

Healthy Volunteers Clinical Trial

— BRADYKID  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02854397
• Other study ID #: 38RC15.180
• Status: Terminated
• Start date: February 15, 2016
• Est. completion date: June 2020

Study information

• Verified date: November 2020
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In emergency room, this is crucial to diagnose an acute attack of hereditary angioedema (HAE) to quickly provide the efficient treatment. Currently, there is no specific biomarker for acute attack of bradykinin-mediated angioedema to help clinicians for patient care. However, previous works are carried out for that purpose. All the potential candidate biomarkers must be validated in prospective studies to estimate their specificity and sensitivity values, and to understand their potential utility in patient care. The main goal of this clinical trial is to estimate the diagnostic value of VE-cadherin in pediatric population, for the differential diagnosis between HAE crisis and angioedema resulting of mast cell activation crisis (the main differential diagnosis of HAE).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

For HAE: patient with a documented diagnosis of HAE:

• type I (from an antigenic deficiency of the C1 esterase inhibitor) or type II (from a functional deficiency of the C1 esterase inhibitor). The existence of a mutation in SERPING1 was not necessary for the inclusion
• HAE with normal C1-INH (ex type III) with a required mutation in FXII gene or with a typical family history of HAE diagnosed by a specialized physician belonging to CREAK network. For AE resulting of mast cell activation: a documented diagnosis of AE resulting of mast

cell activation included:

• mastocytosis,
• chronic spontaneous urticaria,
• acute urticaria after exposure of allergen during allergy challenge tests,
• mast cell activation syndrome.

For the control group:

• composed of patients who presented a stabilized disease (that was not infectious, not auto-inflammatory or inflammatory disease and without implication of endothelial cells).

Exclusion Criteria:

• Over 18 years or under 1 year.
• Diagnosis of HAE with a normal C1 esterase inhibitor or AE of unknown aetiology.
• Patients with HAE who received an acute attack treatment before the blood sample (the C1 esterase inhibitor concentrate or a bradykinin B2 receptor antagonist); patients with HAE who received a prophylactic treatment (danazol).
• Patients who were treated by omalizumab or corticosteroid treatment.

Related Conditions & MeSH terms

• Angioedema
• Healthy Volunteers
• Hereditary Angioedema

Intervention

Other:
• blood sample

Locations

Country	Name	City	State
France	University hospital angers	Angers
France	University Hospital Besançon	Besançon
France	University hospital Bordeaux	Bordeaux
France	University hopital Clermont-Ferrand	Clermont-Ferrand
France	University Hospital Grenoble	Grenoble
France	University Hospital Lille	Lille
France	University Hospital Lyon	Lyon
France	University hospital Marseille	Marseille
France	University hospital Montpellier	Montpellier
France	University hospital Nancy	Nancy
France	General Hospital	Niort
France	university hospital Saint-Antoine (AP-HP)	Paris
France	University hospital Rouen	Rouen
France	University hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (39)

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Sidibé A, Polena H, Pernet-Gallay K, Razanajatovo J, Mannic T, Chaumontel N, Bama S, Maréchal I, Huber P, Gulino-Debrac D, Bouillet L, Vilgrain I. VE-cadherin Y685F knock-in mouse is sensitive to vascular permeability in recurrent angiogenic organs. Am J Physiol Heart Circ Physiol. 2014 Aug 1;307(3):H455-63. doi: 10.1152/ajpheart.00774.2013. Epub 2014 May 23. — View Citation

Sidibé A, Polena H, Razanajatovo J, Mannic T, Chaumontel N, Bama S, Maréchal I, Huber P, Gulino-Debrac D, Bouillet L, Vilgrain I. Dynamic phosphorylation of VE-cadherin Y685 throughout mouse estrous cycle in ovary and uterus. Am J Physiol Heart Circ Physiol. 2014 Aug 1;307(3):H448-54. doi: 10.1152/ajpheart.00773.2013. Epub 2014 May 23. — View Citation

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VE-cadherin level	For the diagnosis of acute attack of hereditary angioedema	Half a day
Secondary	Dosage of VE-cadherin (vascular endothelial)	Analysis of the cleaved fragments from high molecular weight kininogen	Half a day
Secondary	Dosage of Fc KHPM	Analysis of the cleaved fragments from high molecular weight kininogen	Half a day
Secondary	Dosage of D-dimer	Analysis of the cleaved fragments from high molecular weight kininogen	Half a day
Secondary	Dosage of Tryptase	Analysis of the cleaved fragments from high molecular weight kininogen	Half a day