Clinical Trial: Determination of Specific Biomarkers of Angioneurotic Crisis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Determination of Specific Biomarkers of Angioneurotic Crisis

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).


Detailed Summary:
Sponsor: University Hospital, Grenoble

Current Primary Outcome: VE CADHERIN SENSITIVITY AND SPECIFICITY [ Time Frame: 7 DAYS ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • D-DIMERS SENSITIVITY AND SPECIFICITY [ Time Frame: 7 DAYS ]
  • C1INHIBITOR [ Time Frame: 7 DAYS ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Grenoble

Dates:
Date Received: June 28, 2016
Date Started: October 2012
Date Completion: October 2017
Last Updated: November 16, 2016
Last Verified: November 2016