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

Azienda Ospedaliero Universitaria di Sassari

Status: Unknown

Conditions: Coronary Heart Disease; Rheumatoid Arthritis

Treatments: Device: Endothelial Dysfunction evaluation by EndoPAT

Study type: Observational

Funder types: Other

Identifiers

NCT02341066

H89D14000850003

GR-2011-02352816 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 45 to 84 years old

Volunteers: No Healthy Volunteers

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

Trial design

3,000 participants in 1 patient group

Rheumatoid Arthritis

Description:

Rheumatoid arthritis patients free of overt cardiovascular disease. Endothelial Dysfunction evaluation by EndoPAT

Treatment:

Device: Endothelial Dysfunction evaluation by EndoPAT