Lipid Research Clinics Population Studies

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005128
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: April 2004
  Purpose

To conduct epidemiologic surveys of the distribution, causes, and consequences of the dyslipoproteinemias. The Population Studies include the Prevalence Study, the Family Study, and the Mortality Follow-up Study and shared the same general population base.


Condition
Cardiovascular Diseases
Atherosclerosis
Coronary Disease
Heart Diseases
Hyperlipoproteinemia

Study Type: Observational

Resource links provided by NLM:


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

Study Start Date: July 1972
Estimated Study Completion Date: December 1994
  Hide Detailed Description

Detailed Description:

BACKGROUND:

The Lipid Research Clinics program was created in 1971. The objectives were to evaluate the then current techniques for diagnosis of hyperlipoproteinemia; to acquire data across all age groups on the prevalence of different types of hyperlipoproteinemia, particularly genetically determined forms; to collect high quality data on the prevalence and incidence of atherosclerosis in different patterns of hyperlipoproteinemia; and to improve methods for detection, diagnosis, and medical care of coronary heart disease. The program consisted of the Population Studies and the Coronary Primary Prevention Trial. The coronary primary prevention trial is described under Clinical Trials in the database.

As a result of the establishment of the U.S.-U.S.S.R. Joint Program in Cardiovascular Diseases in 1972, lipid research clinics were established in Moscow and Leningrad in 1974. The U.S.S.R. component of this collaborative research consisted of two Prevalence Studies and a Follow-up Study, all of which closely followed the U.S. Lipid Research Clinics Prevalence Study protocol.

DESIGN NARRATIVE:

Prevalence Study:

The Prevalence Study was initiated in 1972 to determine the prevalence of different types of dyslipoproteinemias at ten North American Lipid Research Clinics. The Prevalence Study consisted of two screens designated as Visit 1 and Visit 2, and was conducted according to a standardized protocol in well-defined target populations. Data collection began in 1972 and ended in 1976. The median time between the two screens was 96 days. The objectives of Visit 1 were: to provide estimates of the prevalence of dyslipidemia in specified populations; to investigate the distribution of cholesterol and triglyceride; and to select participants for Visit 2. A total of 60,502 eligible participants were screened at visit 1. A 15 percent random sample (N=9,107) of all Visit 1 participants who had elevated lipids (N=6,882) or were taking lipid-altering medication (N=346) were asked to return for the Lipid Research Clinics Population Studies Visit 2 screen. The three groups of 16,335 participants represented approximately 25 percent of all subject screened at Visit 1. The objectives of Visit 2 were: to identify participants with primary or secondary dyslipoproteinemia; to determine the prevalence of lipid and lipoprotein patterns and their associations with coronary heart disease, other vascular diseases, and other risk factors for coronary heart disease; and to determine the relationships between lipids and lipoprotein patterns and selected nutritional, physiologic, and sociodemographic variables such as education and occupation of head of household, smoking, blood pressure, height, weight, triceps skinfold, Quetelet index, and sex hormone usage by females. Visit 2 procedures included an interview, a physical examination, an ECG, clinical chemistries, and one-day dietary recall.

Family Study:

The Family Study provided data on the relationship of familial and genetic attributes to plasma lipids and lipoproteins. A sample of all participants in Visit 2 of the Prevalence Study was chosen to participate as probands. Basic demographic information was collected and plasma lipids and lipoproteins were measured on all first-degree relatives and probands. The Family Study was initiated in 1975 and data collection was completed in 1978.

Follow-Up Study:

The Follow-up Study, initiated in 1977, was designed to relate the baseline observation made in 1972-1976 to total and cause-specific mortality. The study assessed the risk factor status of plasma triglycerides, HDL cholesterol and exercise electrocardiography for cardiovascular disease mortality in general, and coronary heart disease in particular. Follow-up baseline measurements included lipid and other clinical chemistries, one-day dietary recalls, medication histories and physical examinations. Assessments were also made of the relationships of estrogen use in women to subsequent cardiovascular disease, coronary heart disease, and cancer mortality and of the relationships of lipids and lipoprotein levels to site-specific cancer, as well as the relationship of retinol levels to cancer mortality.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Williams OD, Heiss G., Beaglehole R, Dennis B, Bazzarre T, and Tyroler HA: Hyperlipidemia and Nutrition - Data Base and Trends. Atherosclerosis Reviews 7:145-156, 1980
Sheffield LT, Haskell W, Heiss G, Kioschos M, Leon A, Roitman D, Schrott H: Safety of Exercise Testing Volunteer Subjects. The Lipid Research Clinics Prevalence Study Experience. J Cardiac Rehab 2(5):395-400, 1982
Rifkind BM, Heiss G, Tyroler HA, Williams OD: The Epidemiology of High Density Lipoproteins: The Lipid Research Clinics Program Prevalence Study. In: Proceedings of the Fourth International Meeting on Atherosclerosis - Atherosclerosis Clinical Evaluation and Therapy. Lenzi S, Descovich GC (Eds) Lancaster, England: MTP Press, Ltd., pp. 61-75, 1982
US-USSR Steering Committee for Problem Area 1: A Comparison of High Blood Pressure Prevalence and Treatment Status in Selected US and USSR Populations. The Pathogenesis of Atherosclerosis. In: First Joint US-USSR Symposium on Hypertension, Sochi, USSR, U.S. Department of Health, Education, and Welfare, NIH Publication No. 79-1272, 432-433, August, 1979
Lipid Research Clinics Program: Manual of Laboratory Operations, vol. 1. Lipid and Lipoprotein Analysis. Washington, DC., U.S. Government Printing Office, DHEW Publication No. (NIH) 75-628, May 1974
Rifkind BM, Tamir I, Heiss G.: Preliminary High-Density Lipoprotein Findings: The Lipid Research Clinics Program. In: Gotto AM, Jr. Miller NE, Oliver MF, (Eds), High Density Lipoproteins and Atherosclerosis. Amsterdam: Elsevier/North Holland Biomedical press, pp. 109-119, 1978
The Lipid Research Clinics Population Studies Data Book. Volume I. The Prevalence Study. U.S. Department of Health and Human Services. NIH Publication No. 80-1527, July 1980
Rifkind BM, LaRosa J. Heiss G: The Prevalence of Hyperlipidemia in Selected North American Populations. In: Atherosclerosis V. Proceedings of the Fifth International Symposium on Atherosclerosis (Gotto AM, Ed) New York:Springer-Verlag, pp. 264-267; 829-830, 1980
US-USSR Steering Committee for Problem Area 1: US-USSR First Lipoprotein Symposium. Laboratory Research Joint Population Studies, Leningrad, USSR. The Pathogenesis of Atherosclerosis. U.S. Department of Health and Human Services. NIH Publication No. 83-1966, November 1982
Williams OD, Rywik SL, Tyroler HA, Sznajd J, McClish DK, Ingram D, Maciolowski M: The U.S. - Polish Pilot Study. In: USA-Poland Symposium, Ischemic Heart Disease. U.S. Department of Health and Human Services. NIH Publication No. 82-1273, pp. 1-8 March 1982
The Lipid Research Clinics Population Studies Data Book. Volume III. The USSR First Prevalence Study. US Department of Health and Human Services. NIH Publication No.87-2727, November 1986
The Lipid Research Clinics Population Studies Data Book. Volume IV. The USSR Second Prevalence Study. US Department of Health and Human Services. NIH Publication No.90-2995, June 1990
Tyroler HA, Anderson T, Chase G, Ellis L, Mowery R, Valulick D: The Lipid Research Clinics Population-Based Family Study. In: Genetic Analysis of Common Diseases: Applications to Predictive Factors in Coronary Disease. Sing C, Skolnick M, (Eds) New York: Alan Liss, pp 647-652, 1979
Williams OD, Heiss G, Beaglehole R, Dennis B, Bazzarre T, Tyroler HA: Hyperlipidemia and Nutrition: Data Base and Trends. Atherosclerosis Reviews 7:145-156, 1980
Rifkind BM, for the Alcohol-Nutrition, Anthropometry, and Lipoprotein Working Groups of the LRC Program Prevalence Study: Nutrient-High-Density-Lipoprotein Relationships: An Overview. Proceedings of the US-Italy Symposium on Nutrition and Cardiovascular Diseases, Progress in Biochemical Pharmacology (Vol. 19), Hegyeli RJ, (Ed), Karger, Basel, pp. 89-109, 1983
The Lipid Research Clinics Population Studies Data Book. Volume II. The Prevalence Study - Nutrient Intake. U.S. Department of Health and Human Services. NIH Publication No. 82-2014, September 1982
Manual of Laboratory Operations: LRC Program, Vol. 1: Lipid and Lipoprotein Analysis. DHEW Publication No. (NIH) 75-628. May 1974. Revised version issued October, 1982
Bachorik PS, Cooper G, Lippel K, and Ahmed S: Standardization of Cholesterol and Triglyceride Measurements by 12 Lipid Research Clinics. In Protides of the Biological Fluids (Proceedings of the 25th Colloquium), H. Peeters, (Ed). New York: Pergamon Press, pp. 307-314, 1978

ClinicalTrials.gov Identifier: NCT00005128     History of Changes
Other Study ID Numbers: 907
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Coronary Artery Disease
Coronary Disease
Heart Diseases
Hyperlipoproteinemias
Arterial Occlusive Diseases
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014