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临床试验/NCT01864122
NCT01864122已完成不适用

Predictive Value of Coronary Heart Disease (CHD) Biomarkers for CHD Death

Tufts University1 个研究点 分布在 1 个国家目标入组 2,448 人开始时间: 2007年1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
2,448
试验地点
1
主要终点
plasma markers of dietary intake

研究概览

简要总结

The overall objective of this research proposal is to determine whether the predictive value of using plasma concentrations of selected nutrient biomarkers of food intake determined using a single plasma sample either alone or in combination are stronger, objective predictors of subsequent death from coronary heart disease (CHD) or myocardial infarct (MI) compared to selected food intake data derived from subjective, self-reported food frequency questionnaires.

详细描述

The overall objective is to determine whether the predictive value of plasma concentrations of selected nutrient biomarker(s) of food intake determined using a single plasma sample either alone or in combination are stronger, objective predictors of subsequent death from CHD or MI compared to selected food intake data derived from subjective, self-reported food frequency questionnaires. The nutrient biomarkers (phospholipid [PL] eicosapentaenoic acid [EPA], PL docosahexaenoic acid [DHA], PL trans fatty acids, phylloquinone, dihydrophylloquinone) and foods (fish, dark fish and tuna, vegetables, fruits, and whole grains, and unsaturated fat rich foods) targeted have previously been either directly or indirectly associated with CVD risk. We propose to test our overall objective by conducting a nested case-control study using plasma samples and food frequency data from the observational cohort of the Women's Health Initiative (WHI). Our cases (n=1200) will be selected from the subset of women who did not report dietary supplement use and who died of CHD or MI (collectively referred to as WHI CHD cases). The control subjects (n=1200) will be selected from the subset that were free of CHD or MI events and matched with cases for standard National Cholesterol Education Program (NCEP) risk factors (WHI controls). Nutrient biomarker data will be newly generated using stored specimens whereas the selected food intake data have previously been collected by the WHI investigators.

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
65 Years 至 —(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Cases, defined as women with centrally confirmed CHD and fatal or non-fatal myocardial infarction (MI).
  • Control subjects were matched on the basis of age, enrollment date, race/ethnicity and absence of CHD, MI, angina, coronary artery by-pass graft/ percutaneous transluminal coronary angioplasty, congestive heart failure, stroke or peripheral vascular disease at baseline.

排除标准

  • 未提供

结局指标

主要结局

plasma markers of dietary intake

时间窗: 4 years

phospholipid fatty acid profiles

次要结局

  • desaturase indexes(4 years)
  • carotenoids(4 years)
  • self-reported food frequency questionnaire data analysis(2 years)
  • phylloquinone(4 years)
  • dihydrophylloquinone(4 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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