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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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.

Conditions
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Rheumatoid Arthritis, Coronary Heart Disease

Intervention / Treatment
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* Device: Endothelial Dysfunction evaluation by EndoPAT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHD events | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular risk score, Framingham risk score 2-year, Endothelial dysfunction, EndoPAT, Rheumatoid arthritis