跳至主要内容
临床试验/NCT03759002
NCT03759002已完成不适用

Association Between Mean Platelet Volume With Echocardiographic Indices and Carotid Intima Media Thickness in Children With End Stage Renal Disease.

Isfahan University of Medical Sciences0 个研究点目标入组 102 人开始时间: 2016年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
主要终点
MPV in patients and controls

研究概览

简要总结

Cardiovascular disease (CVD) is the major risk factor for death in end stage renal diseases (ESRD). Approximately 80% of ESRD patients have some degrees of left ventricular abnormalities at initiation of dialysis. Carotid intima media thickness (CIMT) has been widely accepted as an useful marker to assess CVD in ESRD children. In addition, cardiac mechanics parameters are used to evaluate cardiac function more precisely. However, measuring CIMT and cardiac mechanics parameters are expensive and difficult to perform as a routine method. Mean platelet volume (MPV) is a hematological index which shows the size of platelets. Uremic state causes inflammatory condition that affects MPV. Previous studies on people with normal renal function have shown that this parameter can also have association with CVD. However the data in children with ESRD is scarce. The aim of this study is to find a simple hematologic marker to use regularly in ESRD children finding patients at risk of CVD. Therefore, we will investigate the relationship between mean platelet volume and CIMT and cardiac mechanic parameters in children with ESRD.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • Children under 18 years who have being dialyzed (hemodialysis or peritoneal dialysis) regularly more than 6 months, as case group.
  • Age and gender matched healthy children who have been referred for routine medical examination.

排除标准

  • Patients with uncontrolled hypertension (until being stabled)
  • Patients on any kind of antithrombotic agents or NSAIDs
  • Severe obesity
  • Diabetes patients
  • Patients with a past history of CVD or stroke in the last 6 months
  • Passive smokers who contacted daily with high smokers in their houses
  • Patients with known hematologic diseases or malignancies (such as Fanconi Anemia)
  • Uncontrolled hypothyroid or hyperthyroid patients
  • Patients with recent (in the last 4 weeks) catheter or exit -site infection.

结局指标

主要结局

MPV in patients and controls

时间窗: 1 year after study beginning

Comparing the mean of MPV in patients and controls.

Carotid intima media thickness in patients and controls

时间窗: 2 years after study beginning

Comparing the mean of carotid intima media thickness in patients and controls

Echocardiographic indices in patients and controls

时间窗: 1.5 years after study beginning

Comparing the means of echocardiographic indices in patients and controls

Correlation between MPV and ejection fraction

时间窗: 1.5 years after study beginning

Determining correlation between the value of MPV with ejection fraction in patients

Correlation between MPV and left ventricular mass index

时间窗: 1.5 years after study beginning

Determining correlation between the value of MPV with left ventricular mass index in patients

Correlation between MPV and strain rate

时间窗: 1.5 years after study beginning

Determining correlation between the value of MPV with strain rate in patients

Correlation between MPV and global longitudinal strain

时间窗: 1.5 years after study beginning

Determining correlation between the value of MPV with global longitudinal strain in patients

Correlation between MPV and carotid intima media thickness

时间窗: 2 years after study beginning

Determining correlation between the value of MPV with carotid intima media thickness in patients

次要结局

  • MPV and thrombotic events(2 years after study beginning)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amin Abedini

Medical researcher

Isfahan University of Medical Sciences

相似试验