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 Title of Study: “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.”
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: March 2019
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.
- Device: Endothelial Dysfunction evaluation by EndoPAT
- Endothelial dysfunction will be measured assessing reactive hyperemia of digital arteries by using Endo-PAT2000 (Itamar, Israel).
Arms, Groups and Cohorts
- Rheumatoid Arthritis
- Rheumatoid arthritis patients free of overt cardiovascular disease. Endothelial Dysfunction evaluation by EndoPAT
Clinical Trial Outcome Measures
- 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.
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 45 Years
Maximum Age: 84 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Azienda Ospedaliero Universitaria di Sassari
- Azienda Ospedaliero Universitaria di Cagliari
- Provider of Information About this Clinical Study
- Principal Investigator: Gian Luca Erre, MD PhD, MD, PhD – Azienda Ospedaliero Universitaria di Sassari
- Overall Official(s)
- Gian Luca Erre, MD, PhD, Principal Investigator, Azienda Ospedaliero Universitaria di Sassari
- Overall Contact(s)
- Gian Luca Erre, MD, PhD, +39079228448, firstname.lastname@example.org
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