Cardiovascular DiseasesNCT00005128
Lipid Research Clinics Population Studies
An observational study of Cardiovascular Diseases and Atherosclerosis, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Atherosclerosis, Coronary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1972to Dec 1994
- 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 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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Atherosclerosis, Coronary Disease, Heart Diseases, Hyperlipoproteinemia
- Medical subject headings
- Cardiovascular Diseases, Atherosclerosis, Coronary Disease, Heart Diseases, Hyperlipoproteinemias
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1972
- Study completionDec 1994
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (145)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005128
- Sponsor's protocol ID
- 907
- Status last verified
- Apr 2004
- First submitted
- 25 May 2000
- Last updated
- 14 Apr 2016
- Results posted
- No
Publications
Ahmed S, Lippel K, Bachorik PS, Muesing R, Weidman S, Winn C. External quality control survey of triglyceride (triacylglycerol) analyses performed by 12 lipid research clinics. Clin Chem. 1979 Jun;25(6):880-8. No abstract available.
PubMed 445825Bachorik PS, Wood PD, Williams J, Kuchmak M, Ahmed S, Lippel K, Albers J. Automated determination of total plasma cholesterol: a serum calibration technique. Clin Chim Acta. 1979 Aug 15;96(1-2):145-53. doi: 10.1016/0009-8981(79)90064-0.
PubMed 476955Kuba K, Lippel K, Frantz ID Jr. Four electrophoretic methods compared for diagnosis of type III hyperlipoproteinemia. Clin Chem. 1979 Aug;25(8):1471-5.
PubMed 222508Wood PD, Bachorik PS, Albers JJ, Stewart CC, Winn C, Lippel K. Effects of sample aging on total cholesterol values determined by the automated ferric chloride-sulfuric acid and Liebermann-Burchard procedures. Clin Chem. 1980 Apr;26(5):592-7.
PubMed 7261302Warnick GR, Albers JJ, Bachorik PS, Turner JD, Garcia C, Breckinridge C, Kuba K, McNeely S, Hillerman G, King P, Muesing R, Most B, Lippel K. Multilaboratory evaluation of an ultrafiltration procedure for high density lipoprotein cholesterol quantification in turbid heparin-manganese supernates. J Lipid Res. 1981 Aug;22(6):1015-20.
PubMed 7276749Bachorik PS, Most B, Lippel K, Albers JJ, Wood PD. Plasma lipoprotein analysis: relative precision of total cholesterol and lipoprotein-cholesterol measurements in 12 lipid-research-clinics laboratories. Clin Chem. 1981 Jul;27(7):1217-22. No abstract available.
PubMed 7237787Williams 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
Morrison JA, Khoury P, Laskarzewski P, Gartside P, Moore M, Heiss G, Glueck CJ. Hyperalphalipoproteinemia in hypercholesterolemic adults and children. Trans Assoc Am Physicians. 1980;93:230-43.
PubMed 7245576Christensen B, Glueck C, Kwiterovich P, Degroot I, Chase G, Heiss G, Mowery R, Tamir I, Rifkind B. Plasma cholesterol and triglyceride distributions in 13,665 children and adolescents: the Prevalence Study of the Lipid Research Clinics Program. Pediatr Res. 1980 Mar;14(3):194-202. doi: 10.1203/00006450-198003000-00004.
PubMed 6966785Tamir I, Heiss G, Glueck CJ, Christensen B, Kwiterovich P, Rifkind BM. Lipid and lipoprotein distributions in white children ages 6-19 yr. The Lipid Research Clinics Program Prevalence Study. J Chronic Dis. 1981;34(1):27-39. doi: 10.1016/0021-9681(81)90079-5. No abstract available.
PubMed 7451637Wallace RB, Lynch CF, Pomrehn PR, Criqui MH, Heiss G. Alcohol and hypertension: epidemiologic and experimental considerations. The Lipid Research Clinics Program. Circulation. 1981 Sep;64(3 Pt 2):III 41-7.
PubMed 7020983Glueck CJ, Heiss G, Morrison JA, Khoury P, Moore M. Alcohol intake, cigarette smoking and plasma lipids and lipoproteins in 12--19-year-old children. The Collaborative Lipid Research Clinics Prevalence Study. Circulation. 1981 Sep;64(3 Pt 2):III 48-56.
PubMed 7020984Gordon T, Ernst N, Fisher M, Rifkind BM. Alcohol and high-density lipoprotein cholesterol. Circulation. 1981 Sep;64(3 Pt 2):III 63-7.
PubMed 7020986Criqui MH, Wallace RB, Mishkel M, Barrett-Connor E, Heiss G. Alcohol consumption and blood pressure. The lipid research clinics prevalence study. Hypertension. 1981 Sep-Oct;3(5):557-65. doi: 10.1161/01.hyp.3.5.557.
PubMed 7298110Hunninghake D, Wallace RB, Reiland S, Barrett-Connor E, Wahl P, Hoover J, Heiss G. Alterations of plasma lipid and lipoprotein levels associated with benzodiazepine use--the LRC Program Prevalence Study. Atherosclerosis. 1981 Oct;40(2):159-65. doi: 10.1016/0021-9150(81)90034-4.
PubMed 6118165
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid Research Clinics Population Studies
- ClinicalTrials.gov ID
- NCT00005128
- Acronym / sponsor ID
- 907
- Conditions
- Cardiovascular Diseases, Atherosclerosis, Coronary Disease, Heart Diseases, Hyperlipoproteinemia
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1972
- Study completion
- Dec 1994
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Background: PubMed 445825Ahmed S, Lippel K, Bachorik PS, Muesing R, Weidman S, Winn C. External quality control survey of triglyceride (triacylglycerol) analyses performed by 12 lipid research clinics. Clin Chem. 1979 Jun;25(6):880-8. No abstract available.
- Background: PubMed 476955Bachorik PS, Wood PD, Williams J, Kuchmak M, Ahmed S, Lippel K, Albers J. Automated determination of total plasma cholesterol: a serum calibration technique. Clin Chim Acta. 1979 Aug 15;96(1-2):145-53. doi: 10.1016/0009-8981(79)90064-0.
- Background: PubMed 222508Kuba K, Lippel K, Frantz ID Jr. Four electrophoretic methods compared for diagnosis of type III hyperlipoproteinemia. Clin Chem. 1979 Aug;25(8):1471-5.
- Background: PubMed 7261302Wood PD, Bachorik PS, Albers JJ, Stewart CC, Winn C, Lippel K. Effects of sample aging on total cholesterol values determined by the automated ferric chloride-sulfuric acid and Liebermann-Burchard procedures. Clin Chem. 1980 Apr;26(5):592-7.
- Background: PubMed 7276749Warnick GR, Albers JJ, Bachorik PS, Turner JD, Garcia C, Breckinridge C, Kuba K, McNeely S, Hillerman G, King P, Muesing R, Most B, Lippel K. Multilaboratory evaluation of an ultrafiltration procedure for high density lipoprotein cholesterol quantification in turbid heparin-manganese supernates. J Lipid Res. 1981 Aug;22(6):1015-20.
- Background: PubMed 7237787Bachorik PS, Most B, Lippel K, Albers JJ, Wood PD. Plasma lipoprotein analysis: relative precision of total cholesterol and lipoprotein-cholesterol measurements in 12 lipid-research-clinics laboratories. Clin Chem. 1981 Jul;27(7):1217-22. No abstract available.
- BackgroundWilliams 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
- Background: PubMed 7245576Morrison JA, Khoury P, Laskarzewski P, Gartside P, Moore M, Heiss G, Glueck CJ. Hyperalphalipoproteinemia in hypercholesterolemic adults and children. Trans Assoc Am Physicians. 1980;93:230-43.
- Background: PubMed 6966785Christensen B, Glueck C, Kwiterovich P, Degroot I, Chase G, Heiss G, Mowery R, Tamir I, Rifkind B. Plasma cholesterol and triglyceride distributions in 13,665 children and adolescents: the Prevalence Study of the Lipid Research Clinics Program. Pediatr Res. 1980 Mar;14(3):194-202. doi: 10.1203/00006450-198003000-00004.
- Background: PubMed 7451637Tamir I, Heiss G, Glueck CJ, Christensen B, Kwiterovich P, Rifkind BM. Lipid and lipoprotein distributions in white children ages 6-19 yr. The Lipid Research Clinics Program Prevalence Study. J Chronic Dis. 1981;34(1):27-39. doi: 10.1016/0021-9681(81)90079-5. No abstract available.
- Background: PubMed 7020983Wallace RB, Lynch CF, Pomrehn PR, Criqui MH, Heiss G. Alcohol and hypertension: epidemiologic and experimental considerations. The Lipid Research Clinics Program. Circulation. 1981 Sep;64(3 Pt 2):III 41-7.
- Background: PubMed 7020984Glueck CJ, Heiss G, Morrison JA, Khoury P, Moore M. Alcohol intake, cigarette smoking and plasma lipids and lipoproteins in 12--19-year-old children. The Collaborative Lipid Research Clinics Prevalence Study. Circulation. 1981 Sep;64(3 Pt 2):III 48-56.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Atherosclerosis, run by National Heart, Lung, and Blood Institute (NHLBI).
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 14 Apr 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 NCT00005128, which also lists 145 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 14 Apr 2016.