Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 Apr 8;7(4):e014816.
doi: 10.1136/bmjopen-2016-014816.

Association between baseline vitamin D metabolite levels and long-term cardiovascular events in patients with rheumatoid arthritis from the CIMESTRA trial: protocol for a cohort study with patient-record evaluated outcomes

M Herly  1   2 , K Stengaard-Pedersen  3 , K Hørslev-Petersen  4 , M L Hetland  5 , M Østergaard  5 , R Christensen  6 , B B Løgstrup  7 , P Vestergaard  8 , J Pødenphant  9 , P Junker  1 , T Ellingsen  1
Affiliations
Randomized Controlled Trial

Association between baseline vitamin D metabolite levels and long-term cardiovascular events in patients with rheumatoid arthritis from the CIMESTRA trial: protocol for a cohort study with patient-record evaluated outcomes

M Herly et al. BMJ Open. .

Abstract

Introduction: Cardiovascular morbidity and mortality is increased in patients with rheumatoid arthritis (RA), and among these patients, the prevalence of hypovitaminosis D is high. Moreover, low vitamin D levels have been associated with increased cardiovascular risk in healthy subjects.

Objective: To evaluate the long-term risk of cardiovascular events in patients having low total 25-hydroxyvitamin D levels at baseline compared with patients with normal levels, in an efficiently treated, closed cohort of patients with an early diagnosis of RA.

Methods and analysis: This study is a prospective, closed, blinded endpoint cohort study, based on secondary analyses from a previous randomised trial (CIMESTRA study; NCT00209859, approved September 1999) including 160 patients with an early diagnosis of RA from Danish University clinics. Primary outcome will be the proportion of patients with any cardiovascular event in the follow-up period, evaluated using systematic journal audits. Logistic regression models will test the hypothesis that there are more cardiovascular events in enrolled patients with a low level of vitamin D (< 50 nmol/L). Secondarily, Cox regression models, based on survival analysis, will determine the extent to which independent variables (including different levels of vitamin D at baseline) predict whether a cardiovascular event will occur, and also when this will be.

Ethics and dissemination: All patients have received verbal and written information before enrolment, and have given written consent at baseline. To disseminate comprehension of factors of prognostic importance to cardiovascular outcome in RA, we will attempt to have a first draft ready no later than 1 year after the adjudication process has finished. If low vitamin D levels can predict cardiovascular events in RA, it is relevant to take into account in a prediction model, to be considered by patients, physicians and other decision-makers.

Trial registration number: The parental controlled trial is registered as NCT00209859.

Keywords: Cardiovascular co-morbidity; Rheumatoid Arthritis; Vitamin D metabolites.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Classification of events in the CIMESTRA cohort.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Meune C, Touze E, Trinquart L, et al. . Trends in cardiovascular mortality in patients with rheumatoid arthritis over 50 years: a systematic review and meta-analysis of cohort studies. Rheumatology (Oxford) 2009;48:1309–13. 10.1093/rheumatology/kep252 - DOI - PubMed
    1. van Halm VP, Peters MJ, Voskuyl AE, et al. . Rheumatoid arthritis versus diabetes as a risk factor for cardiovascular disease: a cross-sectional study, the CARRE investigation. Ann Rheum Dis 2009;68:1395–400. 10.1136/ard.2008.094151 - DOI - PubMed
    1. Kremers HM, Crowson CS, Therneau TM, et al. . High ten-year risk of cardiovascular disease in newly diagnosed rheumatoid arthritis patients: a population-based cohort study. Arthritis rheum 2008;58:2268–74. 10.1002/art.23650 - DOI - PMC - PubMed
    1. Solomon DH, Goodson NJ, Katz JN, et al. . Patterns of cardiovascular risk in rheumatoid arthritis. Ann Rheum Dis 2006;65:1608–12. 10.1136/ard.2005.050377 - DOI - PMC - PubMed
    1. Zhang Y, Lu N, Peloquin C, et al. . Improved survival in rheumatoid arthritis: a general population-based cohort study. Ann Rheum Dis 2017;76:408–13. - PMC - PubMed

Publication types

MeSH terms

Associated data