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

• Conditions: Rheumatoid Arthritis; Coronary Heart Disease
• Interventions: Device: Endothelial Dysfunction evaluation by EndoPAT

• Registration Number: NCT02341066
• Lead Sponsor: Azienda Ospedaliero Universitaria di Sassari

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.

Study Timeline

• Study First Submitted: 2015-01-14
• Study First Submitted QC: 2015-01-16
• Study First Posted: 2015-01-19
• Study Start: 2015-07
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-25
• Last Update Posted: 2016-02-26
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rheumatoid Arthritis	Endothelial Dysfunction evaluation by EndoPAT	Rheumatoid arthritis patients free of overt cardiovascular disease. Endothelial Dysfunction evaluation by EndoPAT

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Azienda Ospedaliero Universitaria di Sassari, UOC di Reumatologia; 🇮🇹 Sassari, Italy

Complesso Integrato Columbus, UO di Reumatologia; 🇮🇹 Roma, Italy

Policlinico Universitario di Monserrato Azienda Ospedaliera Universitaria di Cagliari; 🇮🇹 Monserrato, Cagliari, Italy