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OpenTrials
Completed

NCT Number: NCT01864122

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

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.

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Key information

Age range

65 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Tufts University

Boston, Massachusetts, 02111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

none

Treatment and study plan

Primary outcomes

  1. plasma markers of dietary intake

    Time frame: 4 years

    phospholipid fatty acid profiles

Secondary outcomes

  1. self-reported food frequency questionnaire data analysis

    Time frame: 2 years

    analysis of data generated from self-reported food questionnaire, documenting types and amounts and frequency of foods consumed

  2. phylloquinone

    Time frame: 4 years

    quantification of phylloquinones

  3. dihydrophylloquinone

    Time frame: 4 years

    quantification of dihydrophylloquinones

  4. desaturase indexes

    Time frame: 4 years

    determination of desaturase indexes

  5. carotenoids

    Time frame: 4 years

    quantification of carotenoids

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • Fred Hutchinson Cancer Center
  • Northwestern University

Registry information

Acronym: WHI

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
May 29, 2013
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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