跳至主要内容
临床试验/NCT03187444
NCT03187444进行中(未招募)不适用

Cardiovascular Risk and Chronic Inflammatory Rheumatism

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年4月24日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
200
试验地点
2
主要终点
Change from baseline of endothelial function

研究概览

简要总结

Chronic inflammatory rheumatism and inflammation can increase the risk of cardiovascular problems. Indeed, these diseases can increase the risk of myocardial infarction. The objective of this project is a better understanding and preventing the risk of cardiovascular problems in chronic inflammatory rheumatism through the study on the long-term flexibility of the arteries, blood markers of cardiovascular risk and muscle mass.

详细描述

All patients over 18 years, with rheumatoid arthritis treated for the first time with conventional anti-TNF therapy, Abatacept, Tocilizumab, Rituximab or patients with spondyloarthritis treated for the first time with NSAIDs that may be associated with conventional background treatments for peripheral or biological (anti-TNF, Usketinumab) may be included. However, they must be subject to a Social Security scheme and will only be able to participate in the research if they give their consent in writing after receiving full information.

In addition to the usual visit and after verification of the criteria of inclusion and signature of consent, arterial stiffness and endothelial function measurement are performed at M0, M6, M12 and every year and also at each change of treatment, By measuring the pulse wave velocity and by determining the Alx by the SphygmoCor XCEL (AtCor Medical Pty Ltd, based in Australia (CE 0120). Cardiac Frequency at rest will be evaluated at M0, M6, M12, every year and also at each change of treatment, by the realization of an electrocardiogram. The intima-media thickness (EIM) of the carotid will be evaluated every 5 years According to the recommendation. EIM is a non-invasive ultrasound technique in which an ultrasound probe is placed opposite the right primitive carotid artery by convention. A measurement of endothelial function will be performed at M0, M6, M12 and then every year in patients

A study of regional myocardial function by high-resolution echocardiography-STI will be carried out at M0, M6, M12 and then every year in non-hypertensive patients, without diabetes, without a cardiovascular history.

A Serum / plasma / urine bank will be constituted at M0, M6, M12, every year and also at each change of treatment to determine the markers of cardiovascular risk. The plasma bank will be used for the determination of nitric oxide.

A study of the body composition dual-energy x-ray absorptiometry (DXA) and pQCT allowing to evaluate lean mass, fat mass and bone mineral mass will be carried out at M0, then every year and also at each change of treatment M6 assessment of lean mass and fat mass only). When DXA is examined, a lateral incidence measurement of the rachis will be performed to calculate an arterial calcification score.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

盲法说明

Open

入排标准

性别
All
接受健康志愿者

入选标准

  • Being older than 18 years
  • Have rheumatoid arthritis or spondyloarthritis (ankylosing spondylitis, psoriatic arthritis)
  • Receive first conventional DMARD or biological treatment (anti-TNF, Abatacept, Tocilizumab, rituximab) for patients with rheumatoid arthritis
  • Receive biological treatment (Abatacept, Tocilizumab, rituximab) for patients with rheumatoid arthritis who have failed anti-TNF treatment.
  • Receive first NSAID (optionally combined with conventional DMARDs in case of peripheral arthritis) or biological treatment (anti-TNF, Usketinumab) for patients with spondyloarthritis.
  • Being subject to a social security scheme
  • Have the capacity to give informed consent and to comply with the study requirements

排除标准

  • Patient refused to sign the consent form
  • Patient under guardianship
  • Patient having already been exposed to a biological as part of its pathology
  • Patient with chronic disease may interfere with cardiovascular disease either by itself or by treatment history
  • For echocardiography high resolution STI: Patients with hypertension, diabetes and cardiovascular history.
  • To evaluate the activity of the autonomic nervous system, patients with hypertension, diabetics, with cardiovascular history with a neurological disease, with vasoactive or chronotropic treatments such as beta-blockers, antiarrhythmics, antihypertensives, anxiolytics, antidepressants
  • Pregnant or lactating women will be temporarily excluded from the study during the period of pregnancy and breastfeeding.

结局指标

主要结局

Change from baseline of endothelial function

时间窗: at 6 months, 12 months

by Tonometry

Change from baseline of an abdominal aortic calcification score (DEXA)

时间窗: at 6 months, 12 months

Change from baseline of food habits

时间窗: at 6 months, 12 months

French FFQ questionnaire

Change from baseline of regional myocardial function

时间窗: at 6 months, 12 months

Change from baseline of body composition

时间窗: at 6 months, 12 months

DEXA, pQCT

Change from baseline of depression (HAD)

时间窗: at 6 months, 12 months

Change from baseline of fibromyalgia (FIRST)

时间窗: at 6 months, 12 months

Change from baseline of the arterial Stiffness

时间窗: at 6 months, 12 months

evaluated by the pulse wave velocity

Change from baseline of resting heart rate

时间窗: at 6 months, 12 months

Change from baseline of intima-media thickness and carotid and femoral atheroma

时间窗: at 5 years

Change from baseline of autonomic nervous system activity

时间窗: at 6 months, 12 months

Change from baseline of hand muscle strength (Handgrip)

时间窗: at 6 months, 12 months

Change from baseline of energy expenditure and physical activity in usual living conditions

时间窗: at 6 months, 12 months

by Android application on smartphone (eMeetingSearch)

Change from baseline of other markers of cardiovascular risk

时间窗: at 6 months, 12 months

troponin, NT_proBNP, adipocytokines, MCP-1, assymetric dimethylaarginine, angiopoietin-2, anti apo A-1, IL-6, IL-17

Change from baseline of inflammatory rheumatism

时间窗: at 6 months, 12 months

by the doctor in charge of the patient

Change from baseline of the frequency of comorbidities during inflammatory rheumatism

时间窗: at 6 months, 12 months

次要结局

未报告次要终点

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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