Coronary Heart Disease, Rheumatoid Arthritis
Conditions
Keywords
Cardiovascular risk score, Framingham risk score 2-year, Endothelial dysfunction, EndoPAT, Rheumatoid arthritis
Brief summary
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
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.
Interventions
DEVICEEndothelial Dysfunction evaluation by EndoPAT
Endothelial dysfunction will be measured assessing reactive hyperemia of digital arteries by using Endo-PAT2000 (Itamar, Israel).
Sponsors
Azienda Ospedaliero Universitaria di Cagliari
Complesso Integrato Columbus, Roma
Azienda Ospedaliero Universitaria di Sassari
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 84 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CHD events | 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. |
Countries
Italy
Contacts
Primary ContactGian Luca Erre, MD, PhD
Outcome results
None listed