Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-07 @ 12:51 AM
Study NCT ID:
NCT01566851
Status:
UNKNOWN
Last Update Posted:
2012-03-29
First Post:
2012-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of EULAR Recommendations for Cardiovascular Risk Management in Patients With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-28', 'studyFirstSubmitDate': '2012-03-27', 'studyFirstSubmitQcDate': '2012-03-28', 'lastUpdatePostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the following items use in the evaluation of the cardiovascular risk factors', 'timeFrame': 'at time = 2 years', 'description': 'At least once a years the prescription of at least one of the following items use in the evaluation of the cardiovascular risk factors:\n\n* Lipides dosage\n* Glycemia\n* HbA1C\n* Stress test\n* Carotid ultra-sonography\n* Coronary or lower limbs arteriography\n* Heart ultra-sonography\n* Cardiology clinic\n* Endocrinology clinic'}], 'secondaryOutcomes': [{'measure': 'the following items use in the evaluation of the cardiovascular risk factors on the sub population', 'timeFrame': 't=0 and t=2 years', 'description': "The same criteria of primary criteria but on the sub population of Povence Alpes Cote-d'Azur region a comparison of these criteria in 2009 (before EULAR recommendations ) and in 2011 (after EULAR recommendations)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiovascular Check-up in Patients With Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'Introduction Cardiovascular diseases are the first cause of death in rheumatoid arthritis (RA). In 2010, EULAR Standing Committee for Clinical Affairs provides 10 recommendations for cardiovascular risk management in patients with rheumatoid arthritis, including a cardiovascular risk assessment annually.\n\nThe goal of this study is to evaluate the application of EULAR recommendations in real life in patients with RA in the french population. Inclusion criteria: all patients over 18 years old with rheumatoid arthritis treated with at least one DMARDS and/or biologic therapy, affiliated to the RSI (regime social des independents which correspond to other branches of the universal healthcare insurance agency). Non inclusion criteria: patients declared as rheumatoid arthritis without DMARDS or biologic therapy or treated with steroids alone. The following analysis will be performed on the whole database of the RSI, without name identification. Evaluation criteria: at least once a years the prescription of at least one of the following items use in the evaluation of the cardiovascular risk factors: lipides dosage, glycemia, HbA1C, stress test, Carotid ultra-sonography, coronary or lower limbs arteriography, heart ultra-sonography, cardiology clinic, endocrinology clinic. This evaluation will be done on the whole national population of RSI for the year 2011 (01/01/2011 - 31/12/2011). On a subgroup of patients from the region "Provence Alpes Côte d\'Azur", the investigators will analyze the year 2009, and compare to year 2011, to evaluate the impact of theses recommendations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with rheumatoid arthritis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years, affiliated to RSI, with rheumatoid arthritis treated with at least one DMARDS and/or biologic therapy\n\nExclusion Criteria:\n\n* patients under 18 years\n* Patients declared as rheumatoid arthritis without DMARDS or biologic therapy or treated with steroids alone'}, 'identificationModule': {'nctId': 'NCT01566851', 'briefTitle': 'Application of EULAR Recommendations for Cardiovascular Risk Management in Patients With Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Application of EULAR Recommendations for Cardiovascular Risk Management in Patients With Rheumatoid Arthritis in France in the Entire Population of the RSI (Other Branches of the Universal Healthcare Insurance Agency)', 'orgStudyIdInfo': {'id': '12-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient', 'description': 'Patients with rheumatoid arthritis', 'interventionNames': ['Other: Cardiovascular check-up']}], 'interventions': [{'name': 'Cardiovascular check-up', 'type': 'OTHER', 'description': 'Cardiovascular check-up once a year in patients with rheumatoid arthritis', 'armGroupLabels': ['Patient']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Liana EULLER-ZIEGLER, PU-PH', 'role': 'CONTACT', 'email': 'euller-ziegler.l@chu-nice.fr', 'phone': '0033 4 92 03 55 12'}, {'name': 'Véronique BREUIL, PU-PH', 'role': 'CONTACT', 'email': 'breuil.v@chu-nice.fr', 'phone': '0033 4 92 03 55 12'}], 'overallOfficials': [{'name': 'Liana EULLER-ZIEGLER, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nice'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}