Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005226
Status:
COMPLETED
Last Update Posted:
2016-02-25
First Post:
2000-05-25
Brief Title:
Epidemiology of Plasma Fatty Acids and Atherosclerosis
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To measure by gas-liquid chromatography the relative concentrations of all saturated and unsaturated fatty acids found in the cholesterol ester and phospholipid fractions of plasma from 4000 subjects participating in the Atherosclerosis Risk in Communities ARIC study The data were used to clarify the role of various fatty acids in atherosclerosis
Detailed Description:
BACKGROUND
The ARIC study is a large population-based prospective multicenter study supported by NHLBI which began in 1986 and is designed to investigate the etiology and natural history of atherosclerosis and cardiovascular risk factors It involves investigation of four cohorts each with 4000 adults ages 45 to 65 from four different communities The study conducts surveillance for hospitalized myocardial infarction fatal cardiovascular disease and stroke in its cohorts and of the community from which they are drawn Events are classified by a Morbidity and Mortality Classification Committee using standardized criteria
Data collected on the ARIC cohort at baseline included a clinical history a physical examination including blood pressure height weight and anthropometry A second history and physical examination were performed after three years and annual telephone interviews were conducted in the intervening years Laboratory studies at baseline and at three years included electrocardiogram pulmonary function tests ultrasonographic examination of both carotids and one popliteal artery for direct visualization of the atherosclerotic process in peripheral large vessels and numerous blood studies Certain hemostatic and lipid tests were performed only in cases with ultrasonographically determined carotid atherosclerosis and matched normal controls
The ARIC clinical history did collect some dietary history using the Willett Questionnaire and asked a few questions regarding fish consumption However specific questions were brief and only semi-quantitative Direct measurement of plasma fatty acid content as an ancillary study in the Minnesota cohort of the ARIC study gave far more objective information on specific fatty acid consumption and was invaluable in sorting out the true role that various fatty acids play in the prevention of coronary heart disease Furthermore measurement of plasma fatty acids in Minnesota ARIC subjects allowed investigation of the relationships between plasma fatty acids composition and the vast amount of laboratory and clinical outcome data which the ARIC study collected Because the clinical and other laboratory data for each ARIC participant were already available in the computerized data base a tremendous amount of valuable information was derived on plasma fatty acid relationships with laboratory findings and clinical outcome in a large randomly selected United States population
DESIGN NARRATIVE
The studies were ancillary to the ARIC study A cross-sectional study examined the association of plasma fatty acids with plasma lipids hemostatic parameters and blood pressure A nested case-control study examined the association of plasma fatty acids in 75 Minnesota cases with carotid atherosclerosis versus 75 normal matched controls A third study examined the association of plasma fatty acids with incident clinical cardiovascular events namely myocardial infarction and stroke
The ARIC study is a large population-based prospective multicenter study supported by NHLBI which began in 1986 and is designed to investigate the etiology and natural history of atherosclerosis and cardiovascular risk factors It involves investigation of four cohorts each with 4000 adults ages 45 to 65 from four different communities The study conducts surveillance for hospitalized myocardial infarction fatal cardiovascular disease and stroke in its cohorts and of the community from which they are drawn Events are classified by a Morbidity and Mortality Classification Committee using standardized criteria
Data collected on the ARIC cohort at baseline included a clinical history a physical examination including blood pressure height weight and anthropometry A second history and physical examination were performed after three years and annual telephone interviews were conducted in the intervening years Laboratory studies at baseline and at three years included electrocardiogram pulmonary function tests ultrasonographic examination of both carotids and one popliteal artery for direct visualization of the atherosclerotic process in peripheral large vessels and numerous blood studies Certain hemostatic and lipid tests were performed only in cases with ultrasonographically determined carotid atherosclerosis and matched normal controls
The ARIC clinical history did collect some dietary history using the Willett Questionnaire and asked a few questions regarding fish consumption However specific questions were brief and only semi-quantitative Direct measurement of plasma fatty acid content as an ancillary study in the Minnesota cohort of the ARIC study gave far more objective information on specific fatty acid consumption and was invaluable in sorting out the true role that various fatty acids play in the prevention of coronary heart disease Furthermore measurement of plasma fatty acids in Minnesota ARIC subjects allowed investigation of the relationships between plasma fatty acids composition and the vast amount of laboratory and clinical outcome data which the ARIC study collected Because the clinical and other laboratory data for each ARIC participant were already available in the computerized data base a tremendous amount of valuable information was derived on plasma fatty acid relationships with laboratory findings and clinical outcome in a large randomly selected United States population
DESIGN NARRATIVE
The studies were ancillary to the ARIC study A cross-sectional study examined the association of plasma fatty acids with plasma lipids hemostatic parameters and blood pressure A nested case-control study examined the association of plasma fatty acids in 75 Minnesota cases with carotid atherosclerosis versus 75 normal matched controls A third study examined the association of plasma fatty acids with incident clinical cardiovascular events namely myocardial infarction and stroke
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL040848 | NIH | None | httpsreporternihgovquickSearchR01HL040848 |