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Dietary Fatty Acids, PPAR Activated Genes, and CHD

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ClinicalTrials.gov Identifier: NCT00071019
Recruitment Status : Completed
First Posted : October 13, 2003
Last Update Posted : April 20, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To examine the relationship between genetic and dietary factors that modify the risk of coronary heart disease (CHD).

Condition or disease
Coronary Disease Cardiovascular Diseases Heart Diseases Myocardial Infarction

Detailed Description:

BACKGROUND:

Coronary heart disease (CHD) is the major cause of death in most industrialized and developing countries. Links between genetic and dietary factors that modify the risk of CHD should give fundamental insight into its causes and improve population-based CHD prevention strategies.

DESIGN NARRATIVE:

The study will identify genes that modulate the association between dietary fatty acids (FAs) and myocardial infarction (MI). The study uses DNA samples obtained during a population-based, case-control study in Costa Rica of 2,150 subjects who experienced myocardial infarctions and 2,150 matched controls. Biochemical measurements, dietary data, and general information are available for this population. One unique aspect of the study is that adipose tissue biomarkers of polyunsaturated FAs will be used to evaluate dietary exposure variables. Adipose tissue biomarkers (i.e., alpha-linolenic and linoleic acid) are very good indicators of intake in this population. Furthermore, this study showed that increased levels of these biomarkers in adipose tissue are strongly associated with decreased risk of MI, whereas an increase in 18:2 trans FAs increase the risk of MI. Gene-diet association studies and a "candidate pathway" approach will be used to elucidate genetic mechanisms that link risk of MI with exposure to polyunsaturated FAs [including cis and trans isomers of linoleic acid (n-6), and alpha-linolenic acid (n-3)]. The focus will be on peroxisome proliferator-activated receptor (PPAR) genes, and PPAR-regulated genes, that are involved in vascular inflammation. Among controls, the investigators will examine whether genetic and dietary factors independently affect biochemical markers (phenotypes) of the proposed genes. They will also test whether these phenotypes are more clearly identified when genetic and dietary factors are examined together. Because polyunsaturated FAs are important as activators of PPARs and their capacity to regulate gene expression at the level of transcription, this metabolic system is a suitable candidate for the study.


Study Design

Study Type : Observational
Actual Enrollment : 4547 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Dietary Fatty Acids, PPAR Activated Genes, and CHD
Study Start Date : September 2003
Primary Completion Date : August 2006
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Biospecimen Retention:   Samples With DNA
Whole blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hispanic American of mestizo background living in Costa Rica
Criteria
First acute MI Living in catchment area Randomly selected controls Matched for age sex and area of residence
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00071019


Sponsors and Collaborators
Harvard School of Public Health
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Hannia Campos Harvard School of Public Health
More Information

Responsible Party: Hannia Campos, Senior Lecturer, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT00071019     History of Changes
Other Study ID Numbers: 1235
R01HL071888 ( U.S. NIH Grant/Contract )
First Posted: October 13, 2003    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Coronary Disease
Coronary Artery Disease
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases