Endothelial Dysfunction Evaluation for Coronary Heart Disease Risk Estimation in Rheumatoid Arthritis (EDRA Study)
NCT ID: NCT02341066
Last Updated: 2016-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
3000 participants
OBSERVATIONAL
2015-07-31
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Rheumatoid Arthritis
Rheumatoid arthritis patients free of overt cardiovascular disease. Endothelial Dysfunction evaluation by EndoPAT
Endothelial Dysfunction evaluation by EndoPAT
Endothelial dysfunction will be measured assessing reactive hyperemia of digital arteries by using Endo-PAT2000 (Itamar, Israel).
Interventions
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Endothelial Dysfunction evaluation by EndoPAT
Endothelial dysfunction will be measured assessing reactive hyperemia of digital arteries by using Endo-PAT2000 (Itamar, Israel).
Eligibility Criteria
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Inclusion 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
* 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
45 Years
84 Years
ALL
No
Sponsors
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Azienda Ospedaliero Universitaria di Cagliari
OTHER
Complesso Integrato Columbus, Roma
UNKNOWN
Azienda Ospedaliero Universitaria di Sassari
OTHER
Responsible Party
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Gian Luca Erre, MD PhD
MD, PhD
Principal Investigators
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Gian Luca Erre, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliero Universitaria di Sassari
Locations
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Policlinico Universitario di Monserrato Azienda Ospedaliera Universitaria di Cagliari
Monserrato, Cagliari, Italy
Complesso Integrato Columbus, UO di Reumatologia
Roma, Roma, Italy
Azienda Ospedaliero Universitaria di Sassari, UOC di Reumatologia
Sassari, Sassari, Italy
Countries
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Central Contacts
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Facility Contacts
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Anna Laura Fedele, MD
Role: primary
Role: backup
References
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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.
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. doi: 10.1016/j.jacc.2004.08.062.
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.
Erre 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.
Sanna 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.
Erre 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.
Erre 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.
Erre 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.
Other Identifiers
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GR-2011-02352816
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H89D14000850003
Identifier Type: -
Identifier Source: org_study_id
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