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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

Tracking Information
First Submitted Date January 14, 2015
First Posted Date January 19, 2015
Last Update Posted Date February 26, 2016
Study Start Date July 2015
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 16, 2015)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Endothelial Dysfunction Evaluation for Coronary Heart Disease Risk Estimation in Rheumatoid Arthritis (EDRA Study)
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.
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).
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Three thousand consecutive RA patients free of overt cardiovascular disease
Condition
  • Rheumatoid Arthritis
  • Coronary Heart Disease
Intervention Device: Endothelial Dysfunction evaluation by EndoPAT
Endothelial dysfunction will be measured assessing reactive hyperemia of digital arteries by using Endo-PAT2000 (Itamar, Israel).
Study Groups/Cohorts Rheumatoid Arthritis
Rheumatoid arthritis patients free of overt cardiovascular disease. Endothelial Dysfunction evaluation by EndoPAT
Intervention: Device: Endothelial Dysfunction evaluation by EndoPAT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 16, 2015)
3000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT02341066
Other Study ID Numbers H89D14000850003
GR-2011-02352816 ( Other Grant/Funding Number: Ministero della Salute )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Gian Luca Erre, MD PhD, Azienda Ospedaliero Universitaria di Sassari
Study Sponsor Azienda Ospedaliero Universitaria di Sassari
Collaborators
  • Azienda Ospedaliero Universitaria di Cagliari
  • Complesso Integrato Columbus, Roma
Investigators
Principal Investigator: Gian Luca Erre, MD, PhD Azienda Ospedaliero Universitaria di Sassari
PRS Account Azienda Ospedaliero Universitaria di Sassari
Verification Date February 2016