CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT02833675
NCT02833675N/ACompleted

Determination of Specific Biomarkers of Angioneurotic Crisis

University Hospital, Grenoble·observational·Posted Jul 14, 2016·Updated Sep 29, 2017

In Brief

An observational study for Angioedema. Completed, enrolled 120 participants across 1 site.

Detailed 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).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAngioedema
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 14, 2016
Enrollment StartOct 1, 2012
Primary CompletionAug 1, 2017
Study CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 10.0 years ago