Trial record 19 of 497 for:    rheumatoid arthritis | Open Studies

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01566851
First received: March 27, 2012
Last updated: March 28, 2012
Last verified: March 2012
  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)

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Study Population

Patients with rheumatoid arthritis

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566851

Contacts
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

Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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 April 17, 2014