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Trial record 6 of 20 for:    "Angioedema" | "Bradykinin"

Determination of Specific Biomarkers of Angioneurotic Crisis (BIOBRAD)

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ClinicalTrials.gov Identifier: NCT02833675
Recruitment Status : Completed
First Posted : July 14, 2016
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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
Angioedema

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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 : October 2012
Actual Primary Completion Date : August 2017
Actual Study Completion Date : September 2017

Group/Cohort
bradykinin angioedema
Hereditary angioedema with or without C1Inhibitor Drug induced angiodema
Histaminergic angioedema
Allergic and non allergic angioedema
Control group
Patients with abdominal pain



Primary Outcome Measures :
  1. VE CADHERIN SENSITIVITY AND SPECIFICITY [ Time Frame: 7 DAYS ]

Secondary Outcome Measures :
  1. D-DIMERS SENSITIVITY AND SPECIFICITY [ Time Frame: 7 DAYS ]
  2. C1INHIBITOR [ Time Frame: 7 DAYS ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with bradykinin and histaminergic angioedema or with abdominal pain
Criteria

Inclusion Criteria:

  • Histaminergic or bradykinin angioedema
  • Abdominal pain

Exclusion Criteria:

  • children < 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02833675


Locations
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France
Grenoble university hospital
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Study Chair: Vanessa espin grenbole university hospital

Publications:
Bowen T, Cicardi M, Farkas H, Bork K, Longhurst HJ, Zuraw B, Aygoeren-Pürsün E, Craig T, Binkley K, Hebert J, Ritchie B, Bouillet L, Betschel S, Cogar D, Dean J, Devaraj R, Hamed A, Kamra P, Keith PK, Lacuesta G, Leith E, Lyons H, Mace S, Mako B, Neurath D, Poon MC, Rivard GE, Schellenberg R, Rowan D, Rowe A, Stark D, Sur S, Tsai E, Warrington R, Waserman S, Ameratunga R, Bernstein J, Björkander J, Brosz K, Brosz J, Bygum A, Caballero T, Frank M, Fust G, Harmat G, Kanani A, Kreuz W, Levi M, Li H, Martinez-Saguer I, Moldovan D, Nagy I, Nielsen EW, Nordenfelt P, Reshef A, Rusicke E, Smith-Foltz S, Späth P, Varga L, Xiang ZY. 2010 International consensus algorithm for the diagnosis, therapy and management of hereditary angioedema. Allergy Asthma Clin Immunol. 2010 Jul 28;6(1):24. doi: 10.1186/1710-1492-6-24.
Cicardi M, Banerji A, Bracho F, Malbrán A, Rosenkranz B, Riedl M, Bork K, Lumry W, Aberer W, Bier H, Bas M, Greve J, Hoffmann TK, Farkas H, Reshef A, Ritchie B, Yang W, Grabbe J, Kivity S, Kreuz W, Levy RJ, Luger T, Obtulowicz K, Schmid-Grendelmeier P, Bull C, Sitkauskiene B, Smith WB, Toubi E, Werner S, Anné S, Björkander J, Bouillet L, Cillari E, Hurewitz D, Jacobson KW, Katelaris CH, Maurer M, Merk H, Bernstein JA, Feighery C, Floccard B, Gleich G, Hébert J, Kaatz M, Keith P, Kirkpatrick CH, Langton D, Martin L, Pichler C, Resnick D, Wombolt D, Fernández Romero DS, Zanichelli A, Arcoleo F, Knolle J, Kravec I, Dong L, Zimmermann J, Rosen K, Fan WT. Icatibant, a new bradykinin-receptor antagonist, in hereditary angioedema. N Engl J Med. 2010 Aug 5;363(6):532-41. doi: 10.1056/NEJMoa0906393. Erratum in: N Engl J Med. 2010 Oct 7;363(15):1486.
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.

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02833675     History of Changes
Other Study ID Numbers: 38RC12.210
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital, Grenoble:
angioedema
C1Inhibitor
bradykinin
Histamin
Additional relevant MeSH terms:
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Angioedema
Bradykinin
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vasodilator Agents