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Sponsors and Collaborators: |
National Heart, Lung, and Blood Institute (NHLBI) Office of Dietary Supplements (ODS) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00404872 |
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 |
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Cardiovascular Diseases Heart Failure, Congestive Atrial Fibrillation Cerebrovascular Accident |
Study Type: | Observational |
Official Title: | n-3 and Trans Fatty Acids and Major Cardiovascular Outcomes |
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) |
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.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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 |
Principal Investigator: | Dariush Mozaffarian, MD, DrPH | Harvard Medical School and Harvard School of Public Health |
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 |
Stroke |
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 |
Pathologic Processes Nervous System Diseases Cardiovascular Diseases |