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Analysis of the Availability of the Treatments for ACE-I and ARB-induced Angioedema

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ClinicalTrials.gov Identifier: NCT02826356
Recruitment Status : Completed
First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
Specific treatments for angiotensin-converting-enzyme inhibitor (ACE-I) and angiotensin-receptor-blocker (ARB)-induced angioedema exist. Early access to these treatments is challenging because they are expensive and have short shelf lives making it illusory that all emergency department (ED) stock them. The aim of this retrospective study was to define, for each patient with a confirmed ACE-I or ARB-induced angioedema, at which step of the care, the specific treatment was administered. The second objective was to analyse the availability of these treatment in the area around Lyon, France and the factors that may influence it.

Condition or disease
ACE-I and ARB-induced Angioedema.

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Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Efficient Treatments for ACE-I and ARB-induced Angioedema Exist and Should be Available to All Patients. Analysis of Their Availability and Influencing Factors in the Area Around Lyon, France
Study Start Date : February 2016
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016



Primary Outcome Measures :
  1. Step of the care allowing the patients to benefit from a specific treatment. [ Time Frame: October 2010 to December 2014 ]
    Three answers are possible. Patients were treated with the specific medication (icatibant or C1-inhibitor concentrate) either in the first ED or by the medical ambulance team, or by the investigators reference center's intensive care unit.


Secondary Outcome Measures :
  1. Epidemiological characteristics [ Time Frame: October 2010 to December 2014 ]
    The investigators collect data such as age, sex, localization of the angioedema.

  2. Triggering treatments [ Time Frame: October 2010 to December 2014 ]
    The investigators detail which ACE-inhibitor, which ARB and eventually which co-medication was taken and triggered the angioedema.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with a specific treatment for bradykinin-mediated angioedema for a severe attack of angioedema due to ACE-inhibitors or ARB during the study period.
Criteria

Inclusion Criteria:

  • Every patient followed for the first time in our reference center for severe confirmed ACE-I or ARB-induced angioedema. Data were analyzed from patients attended either in a specialized angioedema consultation or during a hospitalization in our intensive care unit.
  • Severe attack was defined either by its localization over the shoulder or by an severe abdominal attack.

Exclusion Criteria:

- Patients which received no specific treatment (icatibant, C1-inhibitor concentrate) were excluded.


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): NCT02826356


Locations
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France
Hospices Civils de Lyon, Département d'Anesthésie-Réanimation, Hôpital Edouard Herriot, Lyon, France.
Lyon, France, 69003
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Bernard FLOCCARD, MD Hospices Civils de Lyon, Département d'Anesthésie-Réanimation, Hôpital Edouard Herriot, Lyon, France.

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02826356     History of Changes
Other Study ID Numbers: 69HCL16_0430
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Keywords provided by Hospices Civils de Lyon:
Angioedema
Emergency treatment
Treatment availability
Health Equity
Additional relevant MeSH terms:
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Angioedema
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases