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