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Lipid Research Clinics Population Studies

Primary Purpose

Cardiovascular Diseases, Atherosclerosis, Coronary Disease

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    April 13, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005128
    Brief Title
    Lipid Research Clinics Population Studies
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    April 2004
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1972 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 1994 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Atherosclerosis, Coronary Disease, Heart Diseases, Hyperlipoproteinemia

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria

    12. IPD Sharing Statement

    Citations:
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    445825
    Citation
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    Citation
    Cowan LD, Wallace RB, Barrett-Connor E, Hunninghake D, Pomrehn P, Wahl P, Heiss G. Alterations in clinical chemistry measures associated with oral contraceptive and estrogen use: the Lipid Research Clinics Program Prevalence Study. J Reprod Med. 1982 May;27(5):275-82.
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    Kwiterovich PO Jr, Heiss G, Johnson N, Chase GA, Tamir I, Rifkind B. Assessment of plasma total cholesterol as a test to detect elevated low density (beta) lipoprotein cholesterol levels (type IIa hyperlipoproteinemia) in young subjects from a population-based sample. Am J Epidemiol. 1982 Feb;115(2):192-204. doi: 10.1093/oxfordjournals.aje.a113291.
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    7122431
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    Criqui MH, Mebane I, Wallace RB, Heiss G, Holdbrook MJ. Multivariate correlates of adult blood pressures in nine North American populations: The Lipid Research Clinics Prevalence Study. Prev Med. 1982 Jul;11(4):391-402. doi: 10.1016/0091-7435(82)90043-3. No abstract available.
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    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
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    Jacobs DR Jr, Barrett-Connor E. Retest reliability of plasma cholesterol and triglyceride. The Lipid Research Clinics Prevalence Study. Am J Epidemiol. 1982 Dec;116(6):878-85. doi: 10.1093/oxfordjournals.aje.a113490.
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    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
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    Wahl P, Walden C, Knopp R, Hoover J, Wallace R, Heiss G, Rifkind B. Effect of estrogen/progestin potency on lipid/lipoprotein cholesterol. N Engl J Med. 1983 Apr 14;308(15):862-7. doi: 10.1056/NEJM198304143081502.
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    Rifkind BM, Segal P. Lipid Research Clinics Program reference values for hyperlipidemia and hypolipidemia. JAMA. 1983 Oct 14;250(14):1869-72.
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    Criqui MH, Haskell WL, Heiss G, Tyroler HA, Green P, Rubenstein CJ. Predictors of systolic blood pressure response to treadmill exercise: the Lipid Research Clinics Program Prevalence Study. Circulation. 1983 Aug;68(2):225-33. doi: 10.1161/01.cir.68.2.225.
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    6334097
    Citation
    Greenberg RA, Green PP, Roggenkamp KJ, Barrett-Connor E, Tyroler HA, Heiss G. The constancy of parent-offspring similarity of total cholesterol throughout childhood and early adult life. The Lipid Research Clinics Program Prevalence Study. J Chronic Dis. 1984;37(11):833-8. doi: 10.1016/0021-9681(84)90016-x.
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    Green MS, Heiss G, Rifkind BM, Cooper GR, Williams OD, Tyroler HA. The ratio of plasma high-density lipoprotein cholesterol to total and low-density lipoprotein cholesterol: age-related changes and race and sex differences in selected North American populations. The Lipid Research Clinics Program Prevalence Study. Circulation. 1985 Jul;72(1):93-104. doi: 10.1161/01.cir.72.1.93.
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    Cowan LD, Wilcosky T, Criqui MH, Barrett-Connor E, Suchindran CM, Wallace R, Laskarzewski P, Walden C. Demographic, behavioral, biochemical, and dietary correlates of plasma triglycerides. Lipid Research Clinics Program Prevalence Study. Arteriosclerosis. 1985 Sep-Oct;5(5):466-80. doi: 10.1161/01.atv.5.5.466.
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    3484419
    Citation
    Barrett-Connor E, Wilcosky T, Wallace RB, Heiss G. Resting and exercise electrocardiographic abnormalities associated with sex hormone use in women. The Lipid Research Clinics Program Prevalence Study. Am J Epidemiol. 1986 Jan;123(1):81-8. doi: 10.1093/oxfordjournals.aje.a114226.
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    Eisenberg S, Heiss G, Friedlander Y, Rifkind B, Segal P, Williams OD, Stein Y. Comparison of plasma lipids, lipoproteins and dyslipoproteinemia in Israel and the United States. The Lipid Research Clinics Program Prevalence Study. Atherosclerosis. 1986 Jan;59(1):63-74. doi: 10.1016/0021-9150(86)90034-1.
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    DeLong DM, DeLong ER, Wood PD, Lippel K, Rifkind BM. A comparison of methods for the estimation of plasma low- and very low-density lipoprotein cholesterol. The Lipid Research Clinics Prevalence Study. JAMA. 1986 Nov 7;256(17):2372-7.
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    Walden CE, Knopp RH, Johnson JL, Heiss G, Wahl PW, Hoover JJ. Effect of estrogen/progestin potency on clinical chemistry measures. The Lipid Research Clinics Program Prevalence Study. Am J Epidemiol. 1986 Mar;123(3):517-31. doi: 10.1093/oxfordjournals.aje.a114267.
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    Wilcosky T, Harris R, Weissfeld L. The prevalence and correlates of Rose Questionnaire angina among women and men in the Lipid Research Clinics Program Prevalence Study population. Am J Epidemiol. 1987 Mar;125(3):400-9. doi: 10.1093/oxfordjournals.aje.a114546.
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    Friedlander Y, Bucher KD, Namboodiri KK, Heiss G, Kark JD, Tyroler HA, Eisenberg S, Stein Y, Rifkind BM. Parent-offspring aggregation of plasma lipids in selected populations in North America and Israel. The Lipid Research Clinics Prevalence Study. Am J Epidemiol. 1987 Aug;126(2):268-79. doi: 10.1093/aje/126.2.268.
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    Kalsbeek WD, Kral KM, Wallace RB, Rifkind BM. Comparing mean levels of total cholesterol from visit 2 of the Lipid Research Clinics Prevalence Study with the second National Health and Nutrition Examination Survey. Am J Epidemiol. 1988 Nov;128(5):1038-53. doi: 10.1093/oxfordjournals.aje.a115048.
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    Ekelund LG, Suchindran CM, Karon JM, McMahon RP, Tyroler HA. Black-white differences in exercise blood pressure. The Lipid Research Clinics Program Prevalence Study. Circulation. 1990 May;81(5):1568-74. doi: 10.1161/01.cir.81.5.1568.
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    Ernst N, Fisher M, Smith W, Gordon T, Rifkind BM, Little JA, Mishkel MA, Williams OD. The association of plasma high-density lipoprotein cholesterol with dietary intake and alcohol consumption. The Lipid Research Clinics Prevalence Study. Circulation. 1980 Nov;62(4 Pt 2):IV41-52.
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    Haskell WL, Taylor HL, Wood PD, Schrott H, Heiss G. Strenuous physical activity, treadmill exercise test performance and plasma high-density lipoprotein cholesterol. The Lipid Research Clinics Program Prevalence Study. Circulation. 1980 Nov;62(4 Pt 2):IV53-61.
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    Glueck CJ, Taylor HL, Jacobs D, Morrison JA, Beaglehole R, Williams OD. Plasma high-density lipoprotein cholesterol: association with measurements of body mass. The Lipid Research Clinics Program Prevalence Study. Circulation. 1980 Nov;62(4 Pt 2):IV-62-9.
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    Wallace RB, Hunninghake DB, Reiland S, Barrett-Connor E, Mackenthun A, Hoover J, Wahl P. Alterations of plasma high-density lipoprotein cholesterol levels associated with consumption of selected medications. The Lipid Research Clinics Program Prevalence Study. Circulation. 1980 Nov;62(4 Pt 2):IV77-82.
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    Beaglehole R, Trost DC, Tamir I, Kwiterovich P, Glueck CJ, Insull W, Christensen B. Plasma high-density lipoprotein cholesterol in children and young adults. The Lipid Research Clinics Program Prevalence Study. Circulation. 1980 Nov;62(4 Pt 2):IV83-92.
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    Citation
    Halfon ST, Friedlander Y, Halperin G, Harlap S, Dennis BH, Moore MH, Mowery RL, Tyroler HA, Williams OD. Plasma high-density lipoprotein cholesterol, total cholesterol and triglyceride levels in 17-year-old Jewish residents of Jerusalem: a preliminary report. The Lipid Research Clinics Program Prevalence Study. Circulation. 1980 Nov;62(4 Pt 2):IV93-8.
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    Citation
    Tyroler HA, Glueck CJ, Christensen B, Kwiterovich PO Jr. Plasma high-density lipoprotein cholesterol comparisons in black and white populations. The Lipid Research Clinics Program Prevalence Study. Circulation. 1980 Nov;62(4 Pt 2):IV99-107.
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    Citation
    Heiss G, Haskell W, Mowery R, Criqui MH, Brockway M, Tyroler HA. Plasma high-density lipoprotein cholesterol and socioeconomic status. The Lipid Research Clinics Program Prevalence Study. Circulation. 1980 Nov;62(4 Pt 2):IV108-15.
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    Heiss G, Johnson NJ, Reiland S, Davis CE, Tyroler HA. The epidemiology of plasma high-density lipoprotein cholesterol levels. The Lipid Research Clinics Program Prevalence Study. Summary. Circulation. 1980 Nov;62(4 Pt 2):IV116-36.
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    Williams OD, Stinnett S, Chambless LE, Boyle KE, Bachorik PS, Albers JJ, Lippel K. Populations and methods for assessing dyslipoproteinemia and its correlates. The Lipid Research Clinics Program Prevalence Study. Circulation. 1986 Jan;73(1 Pt 2):I4-11.
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    LaRosa JC, Chambless LE, Criqui MH, Frantz ID, Glueck CJ, Heiss G, Morrison JA. Patterns of dyslipoproteinemia in selected North American populations. The Lipid Research Clinics Program Prevalence Study. Circulation. 1986 Jan;73(1 Pt 2):I12-29.
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    Kwiterovich PO Jr, Stewart P, Probstfield JL, Stinnett S, Chambless LE, Chase GA, Jacobs DR, Morrison JA. Detection of dyslipoproteinemia with the use of plasma total cholesterol and triglyceride as screening tests. The Lipid Research Clinics Program Prevalence Study. Circulation. 1986 Jan;73(1 Pt 2):I30-9.
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    Criqui MH, Cowan LD, Heiss G, Haskell WL, Laskarzewski PM, Chambless LE. Frequency and clustering of nonlipid coronary risk factors in dyslipoproteinemia. The Lipid Research Clinics Program Prevalence Study. Circulation. 1986 Jan;73(1 Pt 2):I40-50.
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    Citation
    Glueck CJ, Laskarzewski PM, Suchindran CM, Chambless LE, Barrett-Connor E, Stewart P, Heiss G, Tyroler HA. Progeny's lipid and lipoprotein levels by parental mortality. The Lipid Research Clinics Program Prevalence Study. Circulation. 1986 Jan;73(1 Pt 2):I51-61.
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    Citation
    Wallace RB, Pomrehn P, Heiss G, Chambless LE, Johnson N, Patten R, Lippel K, Rifkind BM. Alterations in clinical chemistry levels associated with the dyslipoproteinemias. The Lipid Research Clinics Program Prevalence Study. Circulation. 1986 Jan;73(1 Pt 2):I62-9.
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    Wallace RB, Hunninghake DB, Chambless LE, Heiss G, Wahl P, Barrett-Connor E. A screening survey of dyslipoproteinemias associated with prescription drug use. The Lipid Research Clinics Program Prevalence Study. Circulation. 1986 Jan;73(1 Pt 2):I70-9.
    Results Reference
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    3940686
    Citation
    Little JA, Graves K, Suchindran CM, Milner J, McGuire V, Beaton G, Feather T, Mattson FH, Christiansen D, Williams OD. Customary diet, anthropometry, and dyslipoproteinemia in selected North American populations. The Lipid Research Clinics Program Prevalence Study. Circulation. 1986 Jan;73(1 Pt 2):I80-90.
    Results Reference
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    PubMed Identifier
    3940687
    Citation
    Rubenstein C, Romhilt D, Segal P, Heiss G, Chambless LE, Boyle KE, Ekelund LG, Adolph R, Sheffield LT. Dyslipoproteinemias and manifestations of coronary heart disease. The Lipid Research Clinics Program Prevalence Study. Circulation. 1986 Jan;73(1 Pt 2):I91-9.
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    3940676
    Citation
    Pomrehn P, Duncan B, Weissfeld L, Wallace RB, Barnes R, Heiss G, Ekelund LG, Criqui MH, Johnson N, Chambless LE. The association of dyslipoproteinemia with symptoms and signs of peripheral arterial disease. The Lipid Research Clinics Program Prevalence Study. Circulation. 1986 Jan;73(1 Pt 2):I100-7.
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    3940677
    Citation
    Segal P, Insull W Jr, Chambless LE, Stinnett S, LaRosa JC, Weissfeld L, Halfon S, Kwiterovitch PO Jr, Little JA. The association of dyslipoproteinemia with corneal arcus and xanthelasma. The Lipid Research Clinics Program Prevalence Study. Circulation. 1986 Jan;73(1 Pt 2):I108-18.
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    3940678
    Citation
    Wilcosky TC, Kwiterovich PO Jr, Glueck CJ, Suchindran CM, Laskarzewski P, Christensen B, Tyroler HA. Dyslipoproteinemia in black participants. The Lipid Research Clinics Program Prevalence Study. Circulation. 1986 Jan;73(1 Pt 2):I119-25.
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    3940680
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    Available IPD and Supporting Information:
    Available IPD/Information Type
    Individual Participant Data Set
    Available IPD/Information URL
    http://biolincc.nhlbi.nih.gov/studies/lrcps/
    Available IPD/Information Identifier
    LRC-PS
    Available IPD/Information Comments
    NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
    Available IPD/Information Type
    Study Forms
    Available IPD/Information URL
    http://biolincc.nhlbi.nih.gov/studies/lrcps/

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    Lipid Research Clinics Population Studies

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