跳至主要内容
临床试验/NCT03001284
NCT03001284Unknown不适用

Multiple Sclerosis Produces Cardiovascular Subclinical Dysfunction

Carol Davila University of Medicine and Pharmacy0 个研究点目标入组 103 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
103
主要终点
Left ventricle systolic dysfunction - by echocardiography

研究概览

简要总结

Multiple sclerosis (MS), debilitating disease involving primarily the central nervous system, may cause cardiovascular dysfunction, due to autonomous nervous system dysfunction, physical invalidity, increased oxidative stress, and systemic inflammatory status, but the detailed mechanisms are not elucidated. The investigators aimed to assess left and right ventricular (LV and RV) function, left atrial (LA) function, arterial function, and atrial-ventricular-arterial coupling in patients with MS, compared to control subjects. LV systolic and diastolic function and RV function were assessed by 2D- and 3D- echocardiography, tissue Doppler, and speckle tracking echocardiography. LA function was assessed by LA volume index and LA strain. Arterial remodeling and stiffness were assessed by intima media-thickness, pulse wave velocity, and parameters of wave intensity and endothelial function

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 18 and 65 years;
  • patients with confirmed MS diagnosis, both newly diagnosed or already under immunomodulatory treatment;
  • informed consent signed.

排除标准

  • MS treated with mitoxantrone;
  • patients with known cardiovascular disease;
  • presence of other neurological conditions;
  • any renal, pulmonary, hepatic or hematological disease;
  • diabetes mellitus;
  • any degree of arterial hypertension;
  • and difficult acoustic window

结局指标

主要结局

Left ventricle systolic dysfunction - by echocardiography

时间窗: 1 year

Left ventricular diastolic function - by echocardiography

时间窗: 1 year

arterial function - by vascular echography

时间窗: 1 year

Right ventricle systolic dysfunction- by echocardiography

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方
Carol Davila University of Medicine and Pharmacy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Raluca Mincu

Dr

Carol Davila University of Medicine and Pharmacy

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