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Evaluating the Relationship Between Fatty Acids and Heart Disease
This study has been completed.
Sponsors and Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Office of Dietary Supplements (ODS)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00404872
  Purpose

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
Cardiovascular Diseases
Heart Failure, Congestive
Atrial Fibrillation
Cerebrovascular Accident

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome
MedlinePlus related topics: Heart Diseases Heart Failure
U.S. FDA Resources
Study Type: Observational
Official Title: n-3 and Trans Fatty Acids and Major Cardiovascular Outcomes

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Estimated Enrollment: 4766
Study Start Date: January 1989
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participated in the Cardiovascular Health Study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00404872

Locations
United States, Massachusetts
Harvard School of Public Health
Boston, Massachusetts, United States, 02115
Channing Laboratory, Harvard Medical School
Boston, Massachusetts, United States, 02115
United States, Washington
Cardiovascular Health Research Unit, University of Washington
Seattle, Washington, United States, 98101
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Investigators
Principal Investigator: Dariush Mozaffarian, MD, DrPH Harvard Medical School and Harvard School of Public Health
  More Information

Publications:
Study ID Numbers: 1363, R01 HL085710-01
Study First Received: November 27, 2006
Last Updated: January 24, 2008
ClinicalTrials.gov Identifier: NCT00404872  
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Stroke

Study placed in the following topic categories:
Heart Failure
Heart Diseases
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases
Cerebrovascular Disorders
Brain Ischemia
Atrial Fibrillation
Brain Infarction
Infarction
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009