Evaluating the Relationship Between Fatty Acids and Heart Disease

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00404872

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH), Office of Dietary Supplements (ODS) (NIH)

4,766

Enrollment

Locations

209

Duration (Months)

1191.5

Patients Per Site

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Heart Failure, Congestive Atrial Fibrillation Cerebrovascular Accident

Detailed Description

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.

Study Design

Study Type:

Observational

Official Title:

n-3 and Trans Fatty Acids and Major Cardiovascular Outcomes

Study Start Date :

Jan 1, 1989

Actual Primary Completion Date :

Jun 1, 2006

Actual Study Completion Date :

Jun 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Participated in the Cardiovascular Health Study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Channing Laboratory, Harvard Medical School	Boston	Massachusetts	United States	02115
2	Harvard School of Public Health	Boston	Massachusetts	United States	02115
3	Cardiovascular Health Research Unit, University of Washington	Seattle	Washington	United States	98101
4	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98101