Clinical trial NCT02833675: Determination of Specific Biomarkers of Angioneurotic Crisis
Official title: Determination of Specific Biomarkers of Angioneurotic Crisis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angioedema
Keywords: angioedema
C1Inhibitor
bradykinin
Histamin
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with bradykinin and histaminergic angioedema or with abdominal pain

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).


Eligibility criteria: Inclusion Criteria:

* Histaminergic or bradykinin angioedema
* Abdominal pain

Exclusion Criteria:

* children \< 18 years

Primary outcomes:
measure: VE CADHERIN SENSITIVITY AND SPECIFICITY
timeFrame: 7 DAYS
Secondary outcomes:
measure: D-DIMERS SENSITIVITY AND SPECIFICITY
timeFrame: 7 DAYS
measure: C1INHIBITOR
timeFrame: 7 DAYS
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble university hospital
Study officials:
affiliation: grenbole university hospital
name: Vanessa espin
role: STUDY_CHAIR
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