Determination of Specific Biomarkers of Angioneurotic Crisis

NCT02833675 | Completed

• 1 other identifier: 38RC12.210
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Angioedema

Keywords

angioedema; C1Inhibitor; bradykinin; Histamin

Outcome Measures

Primary Outcomes (1)

• VE CADHERIN SENSITIVITY AND SPECIFICITY

  7 DAYS

Secondary Outcomes (2)

• D-DIMERS SENSITIVITY AND SPECIFICITY

  7 DAYS

• C1INHIBITOR

  7 DAYS

Study Arms (3)

bradykinin angioedema

Hereditary angioedema with or without C1Inhibitor Drug induced angiodema

Histaminergic angioedema

Allergic and non allergic angioedema

Control group

Patients with abdominal pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with bradykinin and histaminergic angioedema or with abdominal pain

You may qualify if:

• Histaminergic or bradykinin angioedema
• Abdominal pain

You may not qualify if:

• children \< 18 years

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Grenoble university hospital

Grenoble, 38043, France

Location

Related Publications (23)

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• Brevet: w/o 2008 062314 circulating ve-cadherin as a predictive marker of sensitivity or resistance to anti-tumoral treatment, and improved method for the detection of soluble proteins.

  BACKGROUND

MeSH Terms

Conditions

Angioedema

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Vanessa espin

  grenbole university hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 14, 2016
• Study Start: October 1, 2012
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 29, 2017

Record last verified: 2017-09

Locations

FR (1)