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BIOBRAD: Determination of Specific Biomarkers of Angioneurotic Crisis

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Completed
CT.gov ID
NCT02833675
Collaborator
(none)
120
Enrollment
1
Location
59
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Determination of Specific Biomarkers of Angioneurotic Crisis
    Study Start Date :
    Oct 1, 2012
    Actual Primary Completion Date :
    Aug 1, 2017
    Actual Study Completion Date :
    Sep 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    bradykinin angioedema

    Hereditary angioedema with or without C1Inhibitor Drug induced angiodema
    Histaminergic angioedema

    Allergic and non allergic angioedema
    Control group

    Patients with abdominal pain

    Outcome Measures

    Primary Outcome Measures

    1. VE CADHERIN SENSITIVITY AND SPECIFICITY [7 DAYS]

    Secondary Outcome Measures

    1. D-DIMERS SENSITIVITY AND SPECIFICITY [7 DAYS]

    2. C1INHIBITOR [7 DAYS]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histaminergic or bradykinin angioedema

    • Abdominal pain

    Exclusion Criteria:
    • children < 18 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Grenoble university hospital Grenoble France 38043

    Sponsors and Collaborators

    • University Hospital, Grenoble

    Investigators

    • Study Chair: Vanessa espin, grenbole university hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University Hospital, Grenoble
    ClinicalTrials.gov Identifier:
    NCT02833675
    Other Study ID Numbers:
    • 38RC12.210
    First Posted:
    Jul 14, 2016
    Last Update Posted:
    Sep 29, 2017
    Last Verified:
    Sep 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by University Hospital, Grenoble
    angioedema
    C1Inhibitor
    bradykinin
    Histamin
    Additional relevant MeSH terms:
    Angioedema

    Study Results

    No Results Posted as of Sep 29, 2017