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

Rheumatoid Arthritis Clinical Trial

— EDRA  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02341066
• Other study ID #: H89D14000850003
• Secondary ID: GR-2011-02352816
• Status: Recruiting
• Phase: N/A
• First received: January 14, 2015
• Last updated: February 25, 2016
• Start date: July 2015
• Est. completion date: March 2019

Study information

• Verified date: February 2016
• Source: Azienda Ospedaliero Universitaria di Sassari
• Contact: Gian Luca Erre, MD, PhD
• Phone: +39079228448
• Email: e.gianluca[@]libero.it
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 84 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Rheumatoid Arthritis

Intervention

Device:
• Endothelial Dysfunction evaluation by EndoPAT
Endothelial dysfunction will be measured assessing reactive hyperemia of digital arteries by using Endo-PAT2000 (Itamar, Israel).

Locations

Country	Name	City	State
Italy	Policlinico Universitario di Monserrato Azienda Ospedaliera Universitaria di Cagliari	Monserrato	Cagliari
Italy	Complesso Integrato Columbus, UO di Reumatologia	Roma
Italy	Azienda Ospedaliero Universitaria di Sassari, UOC di Reumatologia	Sassari

Sponsors (3)

Lead Sponsor	Collaborator
Azienda Ospedaliero Universitaria di Sassari	Azienda Ospedaliera Universitaria di Cagliari, Complesso Integrato Columbus, Roma

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CHD events	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.	3 year	No