Application of EULAR Recommendations for Cardiovascular Risk Management in Patients With Rheumatoid Arthritis
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cardiovascular Check-up in Patients With Rheumatoid Arthritis |
Other: Cardiovascular check-up |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| 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) |
- the following items use in the evaluation of the cardiovascular risk factors [ Time Frame: at time = 2 years ] [ Designated as safety issue: No ]
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
- the following items use in the evaluation of the cardiovascular risk factors on the sub population [ Time Frame: t=0 and t=2 years ] [ Designated as safety issue: No ]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)
| Estimated Enrollment: | 7000 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Patient
Patients with rheumatoid arthritis
|
Other: Cardiovascular check-up
Cardiovascular check-up once a year in patients with rheumatoid arthritis
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients with rheumatoid arthritis
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
Contacts and Locations| Contact: Liana EULLER-ZIEGLER, PU-PH | 0033 4 92 03 55 12 | euller-ziegler.l@chu-nice.fr |
| Contact: Véronique BREUIL, PU-PH | 0033 4 92 03 55 12 | breuil.v@chu-nice.fr |
| Principal Investigator: | Liana EULLER-ZIEGLER, PU-PH | CHU de Nice |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Nice |
| ClinicalTrials.gov Identifier: | NCT01566851 History of Changes |
| Other Study ID Numbers: | 12-01 |
| Study First Received: | March 27, 2012 |
| Last Updated: | March 28, 2012 |
| Health Authority: | France: The Commission nationale de l’informatique et des libertés |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013