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

Completed

• Conditions: Cardiovascular Disease

• Registration Number: NCT01864122
• Lead Sponsor: Tufts University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Study First Submitted: 2013-05-03
• Study First Submitted QC: 2013-05-23
• Study First Posted: 2013-05-29
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-26
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2448

Inclusion Criteria

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.

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Exclusion Criteria

none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
plasma markers of dietary intake	4 years	phospholipid fatty acid profiles

Secondary Outcome Measures

Name	Time	Method
carotenoids	4 years
dihydrophylloquinone	4 years
desaturase indexes	4 years
phylloquinone	4 years
self-reported food frequency questionnaire data analysis	2 years

Trial Locations

Locations (1)

Tufts University; 🇺🇸 Boston, Massachusetts, United States