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



Status:Completed
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:10/29/2017
Start Date:January 2007
End Date:October 2010

Use our guide to learn which trials are right for you!

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.

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.

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:
We found this trial at
1
site
Boston, Massachusetts 02111
?
mi
from
Boston, MA
Click here to add this to my saved trials