Endothelial Dysfunction Evaluation for Coronary Heart Disease Risk Estimation in Rheumatoid Arthritis (EDRA Study) (EDRA)

February 25, 2016 updated by: Gian Luca Erre, MD PhD, Azienda Ospedaliero Universitaria di Sassari

Evaluation of a New Score Incorporating Endothelial Dysfunction for the Assessment of Coronary Heart Disease Risk in Patients With Rheumatoid Arthritis: a 3-year Prospective Study.

To evaluate the contribution of the assessment of endothelial dysfunction (ED) in improving coronary hearth disease (CHD) risk stratification obtained by the Framingham risk score (FRS) in rheumatoid arthritis population (RA).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

ED, determined by peripheral arterial tonometry (PAT), will be evaluated at baseline in 3000 RA patients free of previous cardiovascular events. Incident CHD events during the 3-year planned follow-up will be registered. A measure of the incremental yield of ED will be obtained comparing 2-year Framingham risk score for CHD (FRS) and FRS plus ED differential prognostic performances by C-statics and risk reclassification analysis.

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Roma, Italy, 00168
        • Recruiting
        • Complesso Integrato Columbus, UO di Reumatologia
        • Contact:
          • Anna Laura Fedele, MD
        • Contact:
      • Sassari, Italy, 07100
        • Recruiting
        • Azienda Ospedaliero Universitaria di Sassari, UOC di Reumatologia
        • Contact:
    • Cagliari
      • Monserrato, Cagliari, Italy, 09042
        • Recruiting
        • Policlinico Universitario di Monserrato Azienda Ospedaliera Universitaria di Cagliari
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Three thousand consecutive RA patients free of overt cardiovascular disease

Description

Inclusion Criteria:

  • RA as defined by American College of Rheumatology/European League Against Rheumatisms 2010 RA classification criteria
  • In the opinion of investigators, patients must be able to adhere to the study visit schedule and must be capable of giving informed consent

Exclusion Criteria:

  • Previous cardiovascular or cerebrovascular events (acute coronary syndrome, stable angina, stroke, interventional procedures, carotid endarterectomy, symptomatic peripheral artery ischemia)
  • Pathological ECG at rest
  • Sign or symptoms of autonomous nervous system dysfunction
  • Serious infections in the previous 6 months
  • Concomitant severe illness: overt hepatic insufficiency; End stage renal disease (Glomerular Filtration Rate <30 ml/h at Cockrofts-Gault formula); recent diagnosis of cancer
  • Pregnancy
  • Plans to leave target areas of each study site within three years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rheumatoid Arthritis
Rheumatoid arthritis patients free of overt cardiovascular disease. Endothelial Dysfunction evaluation by EndoPAT
Device: Endothelial Dysfunction evaluation by EndoPAT
Endothelial dysfunction will be measured assessing reactive hyperemia of digital arteries by using Endo-PAT2000 (Itamar, Israel).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CHD events
Time Frame: 3 year
The following events will be considered as incident CHD events: myocardial infarction, CHD death, resuscitated cardiac arrest, or definite or probable angina if followed by coronary revascularization.
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero Universitaria di Sassari

Collaborators

Azienda Ospedaliero Universitaria di Cagliari
Complesso Integrato Columbus, Roma

Investigators

  • Principal Investigator: Gian Luca Erre, MD, PhD, Azienda Ospedaliero Universitaria di Sassari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

January 14, 2015

First Submitted That Met QC Criteria

January 16, 2015

First Posted (Estimate)

January 19, 2015

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

February 25, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H89D14000850003
  • GR-2011-02352816 (Other Grant/Funding Number: Ministero della Salute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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