Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-03-26 @ 9:40 PM
Study NCT ID:
NCT02826356
Status:
COMPLETED
Last Update Posted:
2016-07-11
First Post:
2016-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of the Availability of the Treatments for ACE-I and ARB-induced Angioedema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000799', 'term': 'Angioedema'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-07', 'studyFirstSubmitDate': '2016-07-05', 'studyFirstSubmitQcDate': '2016-07-07', 'lastUpdatePostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Step of the care allowing the patients to benefit from a specific treatment.', 'timeFrame': 'October 2010 to December 2014', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Epidemiological characteristics', 'timeFrame': 'October 2010 to December 2014', 'description': 'The investigators collect data such as age, sex, localization of the angioedema.'}, {'measure': 'Triggering treatments', 'timeFrame': 'October 2010 to December 2014', 'description': 'The investigators detail which ACE-inhibitor, which ARB and eventually which co-medication was taken and triggered the angioedema.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Angioedema', 'Emergency treatment', 'Treatment availability', 'Health Equity'], 'conditions': ['ACE-I and ARB-induced Angioedema.']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Severe attack was defined either by its localization over the shoulder or by an severe abdominal attack.\n\nExclusion Criteria:\n\n\\- Patients which received no specific treatment (icatibant, C1-inhibitor concentrate) were excluded.'}, 'identificationModule': {'nctId': 'NCT02826356', 'briefTitle': 'Analysis of the Availability of the Treatments for ACE-I and ARB-induced Angioedema', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '69HCL16_0430'}}, 'contactsLocationsModule': {'locations': [{'zip': '69003', 'city': 'Lyon', 'country': 'France', 'facility': "Hospices Civils de Lyon, Département d'Anesthésie-Réanimation, Hôpital Edouard Herriot, Lyon, France.", 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Bernard FLOCCARD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Hospices Civils de Lyon, Département d'Anesthésie-Réanimation, Hôpital Edouard Herriot, Lyon, France."}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}