Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-02-25 @ 4:49 PM
Study NCT ID:
NCT02341066
Status:
UNKNOWN
Last Update Posted:
2016-02-26
First Post:
2015-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endothelial Dysfunction Evaluation for Coronary Heart Disease Risk Estimation in Rheumatoid Arthritis (EDRA Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-25', 'studyFirstSubmitDate': '2015-01-14', 'studyFirstSubmitQcDate': '2015-01-16', 'lastUpdatePostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CHD events', 'timeFrame': '3 year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiovascular risk score', 'Framingham risk score 2-year', 'Endothelial dysfunction', 'EndoPAT', 'Rheumatoid arthritis'], 'conditions': ['Rheumatoid Arthritis', 'Coronary Heart Disease']}, 'referencesModule': {'references': [{'pmid': '10650300', 'type': 'BACKGROUND', '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. doi: 10.1067/mhj.2000.96469."}, {'pmid': '22521305', 'type': 'BACKGROUND', '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.'}, {'pmid': '15582310', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20394872', 'type': 'BACKGROUND', '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.'}, {'pmid': '20181680', 'type': 'BACKGROUND', '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.'}, {'pmid': '38368495', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '36622121', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '32622695', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '32424028', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '29483841', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Three thousand consecutive RA patients free of overt cardiovascular disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* RA as defined by American College of Rheumatology/European League Against Rheumatisms 2010 RA classification criteria\n* In the opinion of investigators, patients must be able to adhere to the study visit schedule and must be capable of giving informed consent\n\nExclusion Criteria:\n\n* Previous cardiovascular or cerebrovascular events (acute coronary syndrome, stable angina, stroke, interventional procedures, carotid endarterectomy, symptomatic peripheral artery ischemia)\n* Pathological ECG at rest\n* Sign or symptoms of autonomous nervous system dysfunction\n* Serious infections in the previous 6 months\n* Concomitant severe illness: overt hepatic insufficiency; End stage renal disease (Glomerular Filtration Rate \\<30 ml/h at Cockrofts-Gault formula); recent diagnosis of cancer\n* Pregnancy\n* Plans to leave target areas of each study site within three years'}, 'identificationModule': {'nctId': 'NCT02341066', 'acronym': 'EDRA', 'briefTitle': 'Endothelial Dysfunction Evaluation for Coronary Heart Disease Risk Estimation in Rheumatoid Arthritis (EDRA Study)', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero Universitaria di Sassari'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'H89D14000850003'}, 'secondaryIdInfos': [{'id': 'GR-2011-02352816', 'type': 'OTHER_GRANT', 'domain': 'Ministero della Salute'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rheumatoid Arthritis', 'description': 'Rheumatoid arthritis patients free of overt cardiovascular disease. Endothelial Dysfunction evaluation by EndoPAT', 'interventionNames': ['Device: Endothelial Dysfunction evaluation by EndoPAT']}], 'interventions': [{'name': 'Endothelial Dysfunction evaluation by EndoPAT', 'type': 'DEVICE', 'description': 'Endothelial dysfunction will be measured assessing reactive hyperemia of digital arteries by using Endo-PAT2000 (Itamar, Israel).', 'armGroupLabels': ['Rheumatoid Arthritis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09042', 'city': 'Monserrato', 'state': 'Cagliari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Matteo Piga, MD', 'role': 'CONTACT', 'email': 'matteopiga@alice.it', 'phone': '+3907051096142'}], 'facility': 'Policlinico Universitario di Monserrato Azienda Ospedaliera Universitaria di Cagliari', 'geoPoint': {'lat': 39.25642, 'lon': 9.1444}}, {'zip': '00168', 'city': 'Roma', 'state': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anna Laura Fedele, MD', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'annalaurafedele@gmail.com', 'phone': '+39063503731'}], 'facility': 'Complesso Integrato Columbus, UO di Reumatologia', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '07100', 'city': 'Sassari', 'state': 'Sassari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gian Luca Erre, MD, PhD', 'role': 'CONTACT', 'email': 'e.gianluca@libero.it', 'phone': '+39079228448'}], 'facility': 'Azienda Ospedaliero Universitaria di Sassari, UOC di Reumatologia', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}], 'centralContacts': [{'name': 'Gian Luca Erre, MD, PhD', 'role': 'CONTACT', 'email': 'e.gianluca@libero.it', 'phone': '+39079228448'}], 'overallOfficials': [{'name': 'Gian Luca Erre, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliero Universitaria di Sassari'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero Universitaria di Sassari', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Ospedaliero Universitaria di Cagliari', 'class': 'OTHER'}, {'name': 'Complesso Integrato Columbus, Roma', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Gian Luca Erre, MD PhD', 'investigatorAffiliation': 'Azienda Ospedaliero Universitaria di Sassari'}}}}