Evaluating the Relationship Between Fatty Acids and Heart Disease

Cardiovascular Diseases Clinical Trial

Official title:

n-3 and Trans Fatty Acids and Major Cardiovascular Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404872
• Other study ID #: 1363
• Secondary ID: R01HL085710R01HL
• Status: Completed
• Phase: N/A
• First received: November 27, 2006
• Last updated: April 10, 2014
• Start date: January 1989
• Est. completion date: June 2006

Study information

• Verified date: April 2014
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4766
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Participated in the Cardiovascular Health Study

Study Design

N/A

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiovascular Diseases
• Cerebrovascular Accident
• Heart Failure
• Heart Failure, Congestive
• Stroke

Locations

Country	Name	City	State
United States	Channing Laboratory, Harvard Medical School	Boston	Massachusetts
United States	Harvard School of Public Health	Boston	Massachusetts
United States	Cardiovascular Health Research Unit, University of Washington	Seattle	Washington
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Heart, Lung, and Blood Institute (NHLBI), Office of Dietary Supplements (ODS)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation