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临床试验/NCT00613158
NCT00613158已完成不适用

Atherosclerosis Risk Refinement - a Multi-marker Approach Using Microarrays

National Heart, Lung, and Blood Institute (NHLBI)1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2007年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
SA burden, as indicated by coronary artery calcium score and intima-medial thickness

研究概览

简要总结

Cardiovascular disease (CVD), including heart disease, heart attack, high blood pressure, and stroke, is most commonly caused by atherosclerosis, or a hardening of the arteries. Traditional risk factors for CVD include age, high blood pressure, high cholesterol, diabetes, and smoking. Although these established risk factors can be helpful in determining people at risk for developing CVD, the addition of novel gene markers for subclinical, or suspected, atherosclerosis (SA) may enhance CVD risk prediction and understanding of disease mechanisms. This study will compare specific genes of white blood cells in people with significant SA versus people without SA to improve identification of those at risk for developing CVD and to better understand the biological basis of SA.

详细描述

CVD is the leading cause of death worldwide and accounts for almost 40% of deaths each year in the United States. In a person with CVD, oxygenated blood is not adequately distributed throughout the body because of impaired function in the heart and blood vessels. This restricted blood flow can eventually lead to organ damage, heart attack, and stroke. Risk prediction for CVD, which is largely associated with SA, relies on the use of certain traditional risk factors. The widely used Framingham risk score (FRS) has provided excellent risk discrimination and reliable estimates of 10-year risk for CVD, but it does not account for the genetics behind SA. Although numerous studies have investigated novel genetic biomarkers to attempt to add predictive value to the FRS, no single biomarker to date has been able to improve risk prediction in a meaningful way. A multi-marker approach that identifies several novel markers unrelated to traditional risk factors may be more effective in improving the identification of those at risk for CVD. This study will first construct a multi-marker approach that is based on patterns of gene expression in peripheral blood leukocytes (PBLs) and that can serve to identify people with substantial SA. The study will then use this approach to determine whether gene expression patterns of PBLs in people with SA are distinct from those in people without SA.

This study will use previously collected data and specimens, including blood samples and SA imaging, from participants in the Multi-Ethnic Study of Atherosclerosis (MESA) trial and from healthy female participants from Northwestern University. Blood samples will be used for analysis of patterns of gene expression in PBLs. There will be no new study visits for this study.

The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).

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
20 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female participant from the MESA study who has a low Framingham risk score and has either SA or no evidence of SA
  • Healthy female below the age of 40 from Northwestern University.

排除标准

  • 未提供

结局指标

主要结局

SA burden, as indicated by coronary artery calcium score and intima-medial thickness

时间窗: Measured at completion of sample analysis

次要结局

未报告次要终点

研究者

研究点 (1)

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