Clinical trial NCT00404872: Evaluating the Relationship Between Fatty Acids and Heart Disease
Official title: n-3 and Trans Fatty Acids and Major Cardiovascular Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Failure, Congestive
Atrial Fibrillation
Cerebrovascular Accident
Keywords: Stroke
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Office of Dietary Supplements (ODS)
First posted: 2006-11-29
Enrollment: 4766
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes

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.

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.

Eligibility criteria: Inclusion Criteria:

* Participated in the Cardiovascular Health Study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Channing Laboratory, Harvard Medical School
state: Massachusetts
city: Boston
country: United States
facility: Harvard School of Public Health
state: Massachusetts
city: Seattle
country: United States
facility: Cardiovascular Health Research Unit, University of Washington
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Harvard Medical School and Harvard School of Public Health
name: Dariush Mozaffarian, MD, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.