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临床试验/NCT04512404
NCT04512404已完成不适用

Endothelial Microparticles as Potential Biomarkers for Endothelial Dysfunction in Hypercholesterolemia and Its Correlation With Pulse Wave Analysis

Universiti Sains Malaysia1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2016年10月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
EMP level and its correlation with endothelial function by pulse wave analysis

研究概览

简要总结

Endothelial microparticles (EMP) have a promising role as a diagnostic and prognostic tool in the assessment of endothelial function. This study compares the levels of EMP in hypercholesterolaemia patients before and after treatment with statins and correlates it with the current method of assessing endothelial function using pulse wave analysis.

The current available methods to assess endothelial function are tedious and not suitable to be applied clinically. Detecting EMP levels are simpler as it only involves routine blood taking which is better tolerated by patients.

Outcome from this study will contribute to finding a potential diagnostic, prognostic and treatment assessment tool that is suitable to be used clinically. This will have a large impact in the management of cardiovascular-related disease that is prevalent worldwide and increasing in the developed countries.

详细描述

General study objective

To evaluate EMP as a simple diagnostic tool in assessing endothelial function in hypercholesterolaemic patients.

Specific objectives:

  1. To compare the levels of EMP ( Cluster of differentiation (CD)144, CD62e and CD31+/42-) in hypercholesterolaemics before and after statin.
  2. To correlate the levels of EMP with the assessment of endothelial function using pulse wave analysis (PWA) in hypercholesterolaemics before and after statin.

Research design

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
35 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hypercholesterolaemia: ( LDL >4.1 mmol/l)
  • Age 35 years and above
  • Agreeable to the treatment with statin if indicated

排除标准

  • Pregnancy and breast feeding
  • Serious medical illness eg kidney failure, liver failure, stroke and malignancy.
  • Contraindicated to statin

研究组 & 干预措施

hypercholesterolemia

3-hydroxy-3-methylglutaric acid coenzyme A (HMG Co-A) reductase inhibitor Types of drug, dosage and frequency is according to the treating physician. This is an observational study.

Duration of treatment: 3-5 months

干预措施: HMG-CoA Reductase Inhibitor (Drug)

结局指标

主要结局

EMP level and its correlation with endothelial function by pulse wave analysis

时间窗: 3 months (Fourth visit)

EMP level: absolute count Endothelial function by pulse wave analysis

次要结局

未报告次要终点

研究者

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

Nik Nor Izah Nik Ibrahim

Principal Investigator

Universiti Sains Malaysia

研究点 (1)

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