Clinical trial NCT01864122: Predictive Value of Coronary Heart Disease (CHD) Biomarkers for CHD Death
Official title: Predictive Value of Coronary Heart Disease (CHD) Biomarkers for CHD Death
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Keywords: nutrient biomarkers
food frequency questionnaire
predictors of CVD
fatty acids
phylloquinone
dihydrophylloquinone
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: Fred Hutchinson Cancer Center
First posted: 2013-05-29
Enrollment: 2448
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Womens' Health Initiative Observational Study

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.

Eligibility criteria: 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

Primary outcomes:
measure: plasma markers of dietary intake
timeFrame: 4 years
Secondary outcomes:
measure: self-reported food frequency questionnaire data analysis
timeFrame: 2 years
measure: phylloquinone
timeFrame: 4 years
measure: dihydrophylloquinone
timeFrame: 4 years
measure: desaturase indexes
timeFrame: 4 years
measure: carotenoids
timeFrame: 4 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University
state: Massachusetts
Study officials:
affiliation: Tufts University
name: Alice H Lichtenstein, D.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Horn LV, Tian L, Neuhouser ML, Howard BV, Eaton CB, Snetselaar L, Matthan NR, Lichtenstein AH. Dietary patterns are associated with disease risk among participants in the Women's Health Initiative Observational Study. J Nutr. 2012 Feb;142(2):284-91. doi: 10.3945/jn.111.145375. Epub 2011 Dec 21.
citation: Matthan NR, Ooi EM, Van Horn L, Neuhouser ML, Woodman R, Lichtenstein AH. Plasma phospholipid fatty acid biomarkers of dietary fat quality and endogenous metabolism predict coronary heart disease risk: a nested case-control study within the Women's Health Initiative observational study. J Am Heart Assoc. 2014 Aug 13;3(4):e000764. doi: 10.1161/JAHA.113.000764.