Predictive Value of Coronary Heart Disease (CHD) Biomarkers for CHD Death
WHI
1 other identifier
observational
2,448
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2007
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 3, 2013
CompletedFirst Posted
Study publicly available on registry
May 29, 2013
CompletedMay 6, 2025
October 1, 2017
3.8 years
May 3, 2013
May 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
plasma markers of dietary intake
phospholipid fatty acid profiles
4 years
Secondary Outcomes (5)
self-reported food frequency questionnaire data analysis
2 years
phylloquinone
4 years
dihydrophylloquinone
4 years
desaturase indexes
4 years
carotenoids
4 years
Eligibility Criteria
Womens' Health Initiative Observational Study
You may qualify if:
- 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.
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tufts Universitylead
- Northwestern Universitycollaborator
- Fred Hutchinson Cancer Centercollaborator
Study Sites (1)
Tufts University
Boston, Massachusetts, 02111, United States
Related Publications (2)
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.
PMID: 22190026BACKGROUNDMatthan 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.
PMID: 25122663BACKGROUND
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Alice H Lichtenstein, D.Sc.
Tufts University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2013
First Posted
May 29, 2013
Study Start
January 1, 2007
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
May 6, 2025
Record last verified: 2017-10