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

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ClinicalTrials.gov Identifier: NCT02341066
Recruitment Status : Unknown
Verified February 2016 by Gian Luca Erre, MD PhD, Azienda Ospedaliero Universitaria di Sassari.
Recruitment status was:  Recruiting
First Posted : January 19, 2015
Last Update Posted : February 26, 2016
Sponsor:
Collaborators:
Azienda Ospedaliero Universitaria di Cagliari
Complesso Integrato Columbus, Roma
Information provided by (Responsible Party):
Gian Luca Erre, MD PhD, Azienda Ospedaliero Universitaria di Sassari

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).

Condition or disease Intervention/treatment
Rheumatoid Arthritis Coronary Heart Disease Device: Endothelial Dysfunction evaluation by EndoPAT

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.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Study Start Date : July 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Rheumatoid Arthritis
Rheumatoid arthritis patients free of overt cardiovascular disease. Endothelial Dysfunction evaluation by EndoPAT
Device: Endothelial Dysfunction evaluation by EndoPAT
Endothelial dysfunction will be measured assessing reactive hyperemia of digital arteries by using Endo-PAT2000 (Itamar, Israel).




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   45 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Three thousand consecutive RA patients free of overt cardiovascular disease
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341066


Contacts
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Contact: Gian Luca Erre, MD, PhD +39079228448 e.gianluca@libero.it

Locations
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Italy
Policlinico Universitario di Monserrato Azienda Ospedaliera Universitaria di Cagliari Recruiting
Monserrato, Cagliari, Italy, 09042
Contact: Matteo Piga, MD    +3907051096142    matteopiga@alice.it   
Complesso Integrato Columbus, UO di Reumatologia Recruiting
Roma, Italy, 00168
Contact: Anna Laura Fedele, MD         
Contact    +39063503731    annalaurafedele@gmail.com   
Azienda Ospedaliero Universitaria di Sassari, UOC di Reumatologia Recruiting
Sassari, Italy, 07100
Contact: Gian Luca Erre, MD, PhD    +39079228448    e.gianluca@libero.it   
Sponsors and Collaborators
Azienda Ospedaliero Universitaria di Sassari
Azienda Ospedaliero Universitaria di Cagliari
Complesso Integrato Columbus, Roma
Investigators
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Principal Investigator: Gian Luca Erre, MD, PhD Azienda Ospedaliero Universitaria di Sassari
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gian Luca Erre, MD PhD, MD, PhD, Azienda Ospedaliero Universitaria di Sassari
ClinicalTrials.gov Identifier: NCT02341066    
Other Study ID Numbers: H89D14000850003
GR-2011-02352816 ( Other Grant/Funding Number: Ministero della Salute )
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: February 2016
Keywords provided by Gian Luca Erre, MD PhD, Azienda Ospedaliero Universitaria di Sassari:
Cardiovascular risk score
Framingham risk score 2-year
Endothelial dysfunction
EndoPAT
Rheumatoid arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases