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Determination of Specific Biomarkers of Angioneurotic Crisis

Determination of Specific Biomarkers of Angioneurotic Crisis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02833675
Acronym
BIOBRAD
Enrollment
120
Registered
2016-07-14
Start date
2012-10-31
Completion date
2017-09-30
Last updated
2017-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angioedema

Keywords

angioedema, C1Inhibitor, bradykinin, Histamin

Brief summary

Diagnosis of angioedema (AE) is difficult especially in emergency room. Two forms should be evoked: histaminic AE (allergic or not, which represent 95% of cases) and bradykinic AE (hereditary or acquired deficiency, with or without C1 Inhibitor) rarer but with more severe prognosis. The distinction is based on clinical features (spontaneous crisis duration, presence of concomitant hives, atopic history...). Sometimes it could be difficult to make the difference. Nowadays, there is no biological marker of the crisis. The search for biomarkers could improve the diagnostic and therapeutic management of AE. Previous work has identified targets: D-dimer, C4, and VE-cadherin. We wanted to know the sensitivity and specificity of these markers. We conducted a prospective study evaluating the D-dimer assays, complement and VE-cadherin during an episode of AE. Three groups of patients were tested: bradykinic AE (peripheral or abdominal attacks), histaminic AE, and abdominal pain (non-bradykinic and non-histaminic etiology) at the time (day 0) and at distance from the crisis (D7).

Interventions

None listed

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Histaminergic or bradykinin angioedema * Abdominal pain

Exclusion criteria

* children \< 18 years

Design outcomes

Primary

MeasureTime frame
VE CADHERIN SENSITIVITY AND SPECIFICITY7 DAYS

Secondary

MeasureTime frame
D-DIMERS SENSITIVITY AND SPECIFICITY7 DAYS
C1INHIBITOR7 DAYS

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026