Application of EULAR Recommendations for Cardiovascular Risk Management in Patients With Rheumatoid Arthritis

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Check-up in Patients With Rheumatoid Arthritis
• Intervention / Treatment: Other: Cardiovascular check-up

• Study Type: Observational
• Enrollment (Anticipated): 7000

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with rheumatoid arthritis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient; Patients with rheumatoid arthritis	Other: Cardiovascular check-up; Cardiovascular check-up once a year in patients with rheumatoid arthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Liana EULLER-ZIEGLER, PU-PH, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): November 1, 2012
• Study Completion (Anticipated): November 1, 2012

Study Registration Dates

• First Submitted: March 27, 2012
• First Submitted That Met QC Criteria: March 28, 2012
• First Posted (Estimate): March 29, 2012

Study Record Updates

• Last Update Posted (Estimate): March 29, 2012
• Last Update Submitted That Met QC Criteria: March 28, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 12-01