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

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ClinicalTrials.gov Identifier: NCT01864122
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : October 27, 2017
Sponsor:
Collaborators:
Northwestern University
Fred Hutchinson Cancer Research Center
Information provided by (Responsible Party):
Tufts University

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.

Condition or disease
Cardiovascular Disease

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.

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Study Type : Observational
Actual Enrollment : 2448 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Study Start Date : January 2007
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010



Primary Outcome Measures :
  1. plasma markers of dietary intake [ Time Frame: 4 years ]
    phospholipid fatty acid profiles


Secondary Outcome Measures :
  1. self-reported food frequency questionnaire data analysis [ Time Frame: 2 years ]
  2. phylloquinone [ Time Frame: 4 years ]
  3. dihydrophylloquinone [ Time Frame: 4 years ]
  4. desaturase indexes [ Time Frame: 4 years ]
  5. carotenoids [ Time Frame: 4 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Womens' Health Initiative Observational Study
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864122


Locations
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United States, Massachusetts
Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Northwestern University
Fred Hutchinson Cancer Research Center
Investigators
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Principal Investigator: Alice H Lichtenstein, D.Sc. Tufts University

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT01864122     History of Changes
Other Study ID Numbers: 8141
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Keywords provided by Tufts University:
nutrient biomarkers
food frequency questionnaire
predictors of CVD
fatty acids
phylloquinone
dihydrophylloquinone
Additional relevant MeSH terms:
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Cardiovascular Diseases