Research
Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital
Published

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

Research output: Contribution to journalJournal articleResearchpeer-review

  1. Outcomes reported on the management of COPD exacerbations: a systematic survey of randomised controlled trials

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Fast-track pneumonia pathway focusing on early progressive mobilisation: a clinical feasibility study

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Feasibility of portable continuous laryngoscopy during exercise testing

    Research output: Contribution to journalJournal articleResearchpeer-review

  4. Asthma severity and fertility outcome in women with polycystic ovary syndrome: a registry-based study

    Research output: Contribution to journalJournal articleResearchpeer-review

  5. FeNO-based asthma management results in faster improvement of airway hyperresponsiveness

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. Early occupational intervention for people with low back pain in physically demanding jobs: A randomized clinical trial

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Placebo: den mindst skadelige behandling ved artrose?

    Research output: Contribution to journalJournal articleResearchpeer-review

View graph of relations

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.

Original languageEnglish
JournalB M J Open
Volume7
Issue number4
Pages (from-to)e014816
ISSN2044-6055
DOIs
Publication statusPublished - 8 Apr 2017

Bibliographical note

COPECARE

    Research areas

  • Journal Article

ID: 50632941