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AtherosclerosisNCT00005226

Epidemiology of Plasma Fatty Acids and Atherosclerosis

An observational study of Atherosclerosis and Cardiovascular Diseases, run by University of Minnesota.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 4,000 subjects participating in the Atherosclerosis Risk in Communities (ARIC) study. Read more about this study

Who is it for?
Ages Up to 100 years, men only
How many people
Not given
Where
No sites listed yet
Study dates
Jul 1988to Jun 1992
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 100 years
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

No eligibility criteria

About this study

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 4,000 subjects participating in the Atherosclerosis Risk in Communities (ARIC) study. The data were used to clarify the role of various fatty acids in atherosclerosis.

Read the 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 4,000 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.

Medical subject headings
Atherosclerosis, Cardiovascular Diseases, Heart Diseases

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2000 (estimated)
  2. Study startJul 1988
  3. Study completionJun 1992

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005226
Sponsor's protocol ID
1106
Other IDs
R01HL040848
Status last verified
Feb 2016
First submitted
25 May 2000
Last updated
25 Feb 2016
Results posted
No

Publications

  • Ma J, Folsom AR, Lewis L, Eckfeldt JH. Relation of plasma phospholipid and cholesterol ester fatty acid composition to carotid artery intima-media thickness: the Atherosclerosis Risk in Communities (ARIC) Study. Am J Clin Nutr. 1997 Feb;65(2):551-9. doi: 10.1093/ajcn/65.2.551.

    PubMed 9022543
  • Ma J, Folsom AR, Eckfeldt JH, Lewis L, Chambless LE. Short- and long-term repeatability of fatty acid composition of human plasma phospholipids and cholesterol esters. The Atherosclerosis Risk in Communities (ARIC) Study Investigators. Am J Clin Nutr. 1995 Sep;62(3):572-8. doi: 10.1093/ajcn/62.3.572.

    PubMed 7661119
  • Ma J, Folsom AR, Shahar E, Eckfeldt JH. Plasma fatty acid composition as an indicator of habitual dietary fat intake in middle-aged adults. The Atherosclerosis Risk in Communities (ARIC) Study Investigators. Am J Clin Nutr. 1995 Sep;62(3):564-71. doi: 10.1093/ajcn/62.3.564.

    PubMed 7661118
  • Folsom AR, Ma J, Eckfeldt JH, Shahar E, Wu KK. Plasma phospholipid fatty acid composition and factor VII coagulant activity. Atherosclerosis. 1994 Dec;111(2):199-207. doi: 10.1016/0021-9150(94)90094-9.

    PubMed 7718022

Questions about this trial

What is this clinical trial studying?

An observational study of Atherosclerosis and Cardiovascular Diseases, run by University of Minnesota.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005226, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2016.

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