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
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
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CIMESTRA 试验中类风湿性关节炎患者的基线维生素 D 代谢水平与长期心血管事件之间的关联：采用患者记录评估结果的队列研究方案
作者：
M. Herly;Kristian Stengaard;K. Hørslev;M. Hetland;M. Østergaard;Robin Christensen;B. Løgstrup;P. Vestergaard;J. Pødenphant;P. Junker;T. Ellingsen
类风湿关节炎（RA）患者心血管疾病的发病率和死亡率增加，在这些患者中，维生素D缺乏症的患病率很高。此外，在健康受试者中，低维生素D水平与心血管风险增加有关。目的对早期诊断为RA的患者进行有效治疗的封闭队列研究，评估基线总25-羟基维生素D水平较低的患者与正常水平的患者发生心血管事件的长期风险。本研究是一项前瞻性、封闭、盲法终点队列研究，基于先前随机试验（CIMESTRA研究；NCT00209859, 1999年9月批准）的二次分析，该试验包括160名来自丹麦大学诊所的早期诊断为RA的患者。主要结局将是随访期间发生心血管事件的患者比例，通过系统的期刊审核进行评估。Logistic回归模型将检验低维生素D水平（< 50 nmol/L）的入组患者有更多心血管事件的假设。其次，基于生存分析的Cox回归模型将确定独立变量（包括基线时维生素D的不同水平）预测心血管事件是否会发生以及何时发生的程度。所有患者在入组前都接受了口头和书面信息，并在基线时给予书面同意。为了传播对RA心血管预后重要因素的理解，我们将在评审过程结束后不迟于1年准备好初稿。如果低维生素D水平可以预测类风湿性关节炎的心血管事件，那么在预测模型中考虑到这一点是相关的，供患者、医生和其他决策者考虑。家长对照试验注册号：NCT00209859。
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.
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DOI：
10.1056/nejm199906173402418
发表时间：
1999-06
期刊：
The New England journal of medicine
影响因子：
--
作者：
Williams Kj;I. Tabas
通讯作者：
Williams Kj;I. Tabas
影响因子：
--
作者：
Kremers, Hilal Maradit;Crowson, Cynthia S.;Therneau, Terry M.;Roger, Veronique L.;Gabriel, Sherine E.
通讯作者：
Gabriel, Sherine E.
影响因子：
39
作者：
Beveridge LA;Struthers AD;Khan F;Jorde R;Scragg R;Macdonald HM;Alvarez JA;Boxer RS;Dalbeni A;Gepner AD;Isbel NM;Larsen T;Nagpal J;Petchey WG;Stricker H;Strobel F;Tangpricha V;Toxqui L;Vaquero MP;Wamberg L;Zittermann A;Witham MD;D-PRESSURE Collaboration
通讯作者：
D-PRESSURE Collaboration
IL-1，何去何从？
影响因子：
5.3
作者：
Grebe,Alena;Latz,Eicke
通讯作者：
Latz,Eicke
影响因子：
24
作者：
Al Mheid, Ibhar;Patel, Riyaz;Murrow, Jonathan;Morris, Alanna;Rahman, Ayaz;Fike, Lucy;Kavtaradze, Nino;Uphoff, Irina;Hooper, Craig;Tangpricha, Vin;Alexander, R. Wayne;Brigham, Kenneth;Quyyumi, Arshed A.
通讯作者：
Quyyumi, Arshed A.