- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01864122
Predictive Value of Coronary Heart Disease (CHD) Biomarkers for CHD Death (WHI)
October 26, 2017 updated by: Tufts University
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
2448
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Tufts University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Womens' Health Initiative Observational Study
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
plasma markers of dietary intake
Time Frame: 4 years
|
phospholipid fatty acid profiles
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
self-reported food frequency questionnaire data analysis
Time Frame: 2 years
|
2 years
|
phylloquinone
Time Frame: 4 years
|
4 years
|
dihydrophylloquinone
Time Frame: 4 years
|
4 years
|
desaturase indexes
Time Frame: 4 years
|
4 years
|
carotenoids
Time Frame: 4 years
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alice H Lichtenstein, D.Sc., Tufts University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
May 3, 2013
First Submitted That Met QC Criteria
May 23, 2013
First Posted (Estimate)
May 29, 2013
Study Record Updates
Last Update Posted (Actual)
October 27, 2017
Last Update Submitted That Met QC Criteria
October 26, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8141
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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