Endothelial Dysfunction Evaluation for Coronary Heart Disease Risk Estimation in Rheumatoid Arthritis (EDRA Study)
EDRA
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.
2 other identifiers
observational
3,000
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2015
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2015
CompletedFirst Posted
Study publicly available on registry
January 19, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedFebruary 26, 2016
February 1, 2016
3.7 years
January 14, 2015
February 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Rheumatoid Arthritis
Rheumatoid arthritis patients free of overt cardiovascular disease. Endothelial Dysfunction evaluation by EndoPAT
Interventions
Endothelial dysfunction will be measured assessing reactive hyperemia of digital arteries by using Endo-PAT2000 (Itamar, Israel).
Eligibility Criteria
Three thousand consecutive RA patients free of overt cardiovascular disease
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Policlinico Universitario di Monserrato Azienda Ospedaliera Universitaria di Cagliari
Monserrato, Cagliari, 09042, Italy
Complesso Integrato Columbus, UO di Reumatologia
Roma, Roma, 00168, Italy
Azienda Ospedaliero Universitaria di Sassari, UOC di Reumatologia
Sassari, Sassari, 07100, Italy
Related Publications (10)
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. doi: 10.1067/mhj.2000.96469.
PMID: 10650300BACKGROUNDCrowson 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.
PMID: 22521305BACKGROUNDBonetti 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. doi: 10.1016/j.jacc.2004.08.062.
PMID: 15582310BACKGROUNDMatsuzawa 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.
PMID: 20394872BACKGROUNDRubinshtein 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.
PMID: 20181680BACKGROUNDErre GL, Chessa I, Bassu S, Cavagna L, Carru C, Pintus G, Giordo R, Mangoni AA, Damiano Sanna G, Zinellu A. Association between ischemia-modified albumin (IMA) and peripheral endothelial dysfunction in rheumatoid arthritis patients. Sci Rep. 2024 Feb 17;14(1):3964. doi: 10.1038/s41598-024-54641-5.
PMID: 38368495DERIVEDSanna GD, Piga M, Piga A, Falco O, Ponti E, Cauli A, Floris A, Mangoni AA, Casu G, De Luca G, Erre GL; EDRA Study Group. Prevalence and clinical significance of electrocardiographic signs of atrial myopathy in rheumatoid arthritis: results from the EDRA study. Clin Exp Rheumatol. 2023 Jul;41(7):1427-1433. doi: 10.55563/clinexprheumatol/d9l4lt. Epub 2023 Jan 2.
PMID: 36622121DERIVEDErre GL, Mangoni AA, Passiu G, Bassu S, Castagna F, Carru C, Piga M, Zinellu A, Sotgia S. Comprehensive arginine metabolomics and peripheral vasodilatory capacity in rheumatoid arthritis: A monocentric cross-sectional study. Microvasc Res. 2020 Sep;131:104038. doi: 10.1016/j.mvr.2020.104038. Epub 2020 Jul 2.
PMID: 32622695DERIVEDErre GL, Ferraccioli ES, Piga M, Mangoni A, Passiu G, Gremese E, Ferraccioli G. Antimalarial use and arrhythmias in COVID-19 and rheumatic patients: a matter of dose and inflammation? Ann Rheum Dis. 2021 Mar;80(3):e29. doi: 10.1136/annrheumdis-2020-217828. Epub 2020 May 18. No abstract available.
PMID: 32424028DERIVEDErre GL, Piga M, Fedele AL, Mura S, Piras A, Cadoni ML, Cangemi I, Dessi M, Di Sante G, Tolusso B, Gremese E, Cauli A, Mangoni AA, Saba PS, Carru C, Ferraccioli G, Mathieu A, Passiu G. Prevalence and Determinants of Peripheral Microvascular Endothelial Dysfunction in Rheumatoid Arthritis Patients: A Multicenter Cross-Sectional Study. Mediators Inflamm. 2018 Feb 1;2018:6548715. doi: 10.1155/2018/6548715. eCollection 2018.
PMID: 29483841DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gian Luca Erre, MD, PhD
Azienda Ospedaliero Universitaria di Sassari
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
January 14, 2015
First Posted
January 19, 2015
Study Start
July 1, 2015
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
February 26, 2016
Record last verified: 2016-02