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

Cardiovascular Disease Clinical Trial

— WHI  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864122
• Other study ID #: 8141
• Status: Completed
• Phase: N/A
• First received: May 3, 2013
• Last updated: October 26, 2017
• Start date: January 2007
• Est. completion date: October 2010

Study information

• Verified date: October 2017
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2448
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Locations

Country	Name	City	State
United States	Tufts University	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Tufts University	Fred Hutchinson Cancer Research Center, Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma markers of dietary intake	phospholipid fatty acid profiles	4 years
Secondary	self-reported food frequency questionnaire data analysis		2 years
Secondary	phylloquinone		4 years
Secondary	dihydrophylloquinone		4 years
Secondary	desaturase indexes		4 years
Secondary	carotenoids		4 years