Cardiovascular Check-up in Patients With Rheumatoid Arthritis Clinical Trial
Official title:
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)
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.
The 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.
| Status | Not yet recruiting |
| Enrollment | 7000 |
| Est. completion date | November 2012 |
| Est. primary completion date | November 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients over 18 years, affiliated to RSI, with rheumatoid arthritis treated with at least one DMARDS and/or biologic therapy Exclusion Criteria: - patients under 18 years - Patients declared as rheumatoid arthritis without DMARDS or biologic therapy or treated with steroids alone |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Nice |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | the following items use in the evaluation of the cardiovascular risk factors | 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 |
at time = 2 years | No |
| Secondary | the following items use in the evaluation of the cardiovascular risk factors on the sub population | 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) | t=0 and t=2 years | No |