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Rheumatoid ArthritisEDRANCT02341066

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

An observational study of Rheumatoid Arthritis and Coronary Heart Disease, run by Azienda Ospedaliero Universitaria di Sassari at 3 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 45 to 84 years
Conditions the study is for
Rheumatoid Arthritis, Coronary Heart Disease
What is being tested?
Endothelial Dysfunction evaluation by EndoPAT
Type of treatment
Medical device
How many people
3,000 participants
Where
3 sitesItaly
Study dates
Jul 2015to Mar 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 84 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Three thousand consecutive RA patients free of overt cardiovascular disease

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Gian Luca Erre, MD, PhD contact

+39079228448

e.gianluca@libero.it

Italy3 sites, 3 recruiting

  • Policlinico Universitario di Monserrato Azienda Ospedaliera Universitaria di Cagliari

    Monserrato, Cagliari, 09042

    Matteo Piga, MD, +3907051096142, matteopiga@alice.it

    Recruiting

  • Complesso Integrato Columbus, UO di Reumatologia

    Roma, Roma, 00168

    Anna Laura Fedele, MD

    +39063503731, annalaurafedele@gmail.com

    Recruiting

  • Azienda Ospedaliero Universitaria di Sassari, UOC di Reumatologia

    Sassari, Sassari, 07100

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

    Recruiting

Other trials in Italy

About this 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.

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).

Read the 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.

Being tested
Endothelial Dysfunction evaluation by EndoPAT
Keywords
Cardiovascular risk score, Framingham risk score 2-year, Endothelial dysfunction, EndoPAT, Rheumatoid arthritis
Medical subject headings
Arthritis, Rheumatoid, Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endothelial Dysfunction evaluation by EndoPATDevice

    Endothelial dysfunction will be measured assessing reactive hyperemia of digital arteries by using Endo-PAT2000 (Itamar, Israel).

Study groups in NCT02341066
Study groupRoleWhat they receive
Rheumatoid ArthritisRheumatoid arthritis patients free of overt cardiovascular disease. Endothelial Dysfunction evaluation by EndoPAT
Receives: Device: Endothelial Dysfunction evaluation by EndoPAT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionMar 2019 (estimated)
  4. Study completionMar 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02341066
Sponsor's protocol ID
H89D14000850003
Other IDs
GR-2011-02352816
Acronym
EDRA
Status last verified
Feb 2016
First submitted
14 Jan 2015
Last updated
26 Feb 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 10650300

  • 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.

    PubMed 22521305

  • 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.

    PubMed 15582310

  • 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.

    PubMed 20394872

  • 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.

    PubMed 20181680

  • 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.

    PubMed 38368495

  • 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.

    PubMed 36622121

  • 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.

    PubMed 32622695

  • 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.

    PubMed 32424028

  • 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.

    PubMed 29483841

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis and Coronary Heart Disease, run by Azienda Ospedaliero Universitaria di Sassari at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gian Luca Erre, MD, PhD (+39079228448, e.gianluca@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CHD events (time frame: 3 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02341066, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016.

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