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

Overview

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

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2019

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

  • 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

Primary 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

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

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: 84 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Azienda Ospedaliero Universitaria di Sassari
  • Collaborator
    • 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, e.gianluca@libero.it

References

D'Agostino RB, Russell MW, Huse DM, Ellison RC, Silbershatz H, Wilson PW, Hartz SC. Primary and subsequent coronary risk appraisal: new results from the Framingham study. Am Heart J. 2000 Feb;139(2 Pt 1):272-81. Erratum in: Am Heart J 2002 Jan;143(1):21.

Crowson CS, Matteson EL, Roger VL, Therneau TM, Gabriel SE. Usefulness of risk scores to estimate the risk of cardiovascular disease in patients with rheumatoid arthritis. Am J Cardiol. 2012 Aug 1;110(3):420-4. doi: 10.1016/j.amjcard.2012.03.044. Epub 2012 Apr 20.

Bonetti PO, Pumper GM, Higano ST, Holmes DR Jr, Kuvin JT, Lerman A. Noninvasive identification of patients with early coronary atherosclerosis by assessment of digital reactive hyperemia. J Am Coll Cardiol. 2004 Dec 7;44(11):2137-41.

Matsuzawa Y, Sugiyama S, Sugamura K, Nozaki T, Ohba K, Konishi M, Matsubara J, Sumida H, Kaikita K, Kojima S, Nagayoshi Y, Yamamuro M, Izumiya Y, Iwashita S, Matsui K, Jinnouchi H, Kimura K, Umemura S, Ogawa H. Digital assessment of endothelial function and ischemic heart disease in women. J Am Coll Cardiol. 2010 Apr 20;55(16):1688-96. doi: 10.1016/j.jacc.2009.10.073.

Rubinshtein R, Kuvin JT, Soffler M, Lennon RJ, Lavi S, Nelson RE, Pumper GM, Lerman LO, Lerman A. Assessment of endothelial function by non-invasive peripheral arterial tonometry predicts late cardiovascular adverse events. Eur Heart J. 2010 May;31(9):1142-8. doi: 10.1093/eurheartj/ehq010. Epub 2010 Feb 24.

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