Evaluating the Relationship Between Fatty Acids and Heart Disease

NCT ID: NCT00404872

Last Updated: 2014-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4766 participants

Study Classification

OBSERVATIONAL

Study Start Date

1989-01-31

Study Completion Date

2006-06-30

Brief Summary

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Cardiovascular disease (CVD) affects millions of people in the United States; each year, more people die from CVD than from any other disease. Individuals with low levels of n-3 fatty acids and high levels of trans-fatty acids may have an increased risk of developing CVD. This study will evaluate the link between fatty acids and the presence of CVD in older adults.

Detailed Description

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CVD includes diseases that affect the heart and blood vessels, including congestive heart failure (CHF), atrial fibrillation (AF), and stroke. CVD may be associated with low levels of n-3 fatty acids and high levels of trans-fatty acids, but more research is needed to determine the role of various fatty acids in the development of CVD. Results from prior studies on this topic have not always been reliable because data from self-reported dietary questionnaires on fatty acid intake have sometimes been inaccurate. A more effective way to measure levels of fatty acids is to analyze blood samples. This study will use blood samples of participants in the Cardiovascular Health Study, a study that examined CVD risk factors in older adults, to determine the link between various fatty acids and the incidence of CHF, AF, and stroke. The results from this study may help researchers identify the dietary factors that influence the development of CVD in older adults.

This study will examine previously collected data from participants in the Cardiovascular Health Study. There will be no study visits specifically for this study. Plasma samples obtained from participants will be analyzed for the presence of n-3 fatty acids and trans-fatty acids. The study will also determine the incidence of CHF, AF, and stroke and the way in which fatty acids are related to hemodynamics, heart structure and function, electrophysiology, insulin sensitivity, inflammation, endothelial function, and obesity.

Conditions

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Cardiovascular Diseases Heart Failure, Congestive Atrial Fibrillation Cerebrovascular Accident

Eligibility Criteria

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Inclusion Criteria

* Participated in the Cardiovascular Health Study
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Office of Dietary Supplements (ODS)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dariush Mozaffarian, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dariush Mozaffarian, MD, DrPH

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School and Harvard School of Public Health

Locations

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Channing Laboratory, Harvard Medical School

Boston, Massachusetts, United States

Site Status

Harvard School of Public Health

Boston, Massachusetts, United States

Site Status

Cardiovascular Health Research Unit, University of Washington

Seattle, Washington, United States

Site Status

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Fried LP, Borhani NO, Enright P, Furberg CD, Gardin JM, Kronmal RA, Kuller LH, Manolio TA, Mittelmark MB, Newman A, et al. The Cardiovascular Health Study: design and rationale. Ann Epidemiol. 1991 Feb;1(3):263-76. doi: 10.1016/1047-2797(91)90005-w.

Reference Type BACKGROUND
PMID: 1669507 (View on PubMed)

Tell GS, Fried LP, Hermanson B, Manolio TA, Newman AB, Borhani NO. Recruitment of adults 65 years and older as participants in the Cardiovascular Health Study. Ann Epidemiol. 1993 Jul;3(4):358-66. doi: 10.1016/1047-2797(93)90062-9.

Reference Type BACKGROUND
PMID: 8275211 (View on PubMed)

Other Identifiers

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R01HL085710

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01HL085710-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1363

Identifier Type: -

Identifier Source: org_study_id

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