Cardiovascular DiseasesNCT00005188
Quantitative Genetic Analysis of Lipid Research Clinic Family Data
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To assess the mode of inheritance of familial combined hyperlipidemia and familial primary hypoalphalipoproteinemia and to resolve genetic and familial environmental effects on several phenotypes of importance to coronary heart disease. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1986to Jun 1991
- 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 assess the mode of inheritance of familial combined hyperlipidemia and familial primary hypoalphalipoproteinemia and to resolve genetic and familial environmental effects on several phenotypes of importance to coronary heart disease.
Read the detailed description
BACKGROUND:
Although coronary heart disease has long been known to aggregate in families, in 1986 little was known about the relative importance of genetic and environmental factors. This was partly due to the heterogeneous nature of the disease. Instead of analyzing complex endpoints, the tendency had been to focus on the individual risk factors or phenotypes. Plasma lipids and lipoproteins are heterogeneous risk factors that have been analyzed as subgroups from a genetic epidemiological perspective. Attention turned to the familial aggregation of risk factors, particularly the hyperlipidemias, hypertension, and diabetes.
In 1971, the National Heart and Lung Institute began a series of epidemiologic studies at several North American sites under the Lipid Research Clinics Program. The Family Study was designed to investigate the familial association of blood lipids, lipoproteins, and dyslipoproteinemias. This study complemented and did not duplicate ongoing analysis of Lipid Research Clinics data.
DESIGN NARRATIVE:
The study addressed seven phenotypes, all derived from fasting blood samples: total cholesterol, total triglyceride, LDL-cholesterol, HDL-cholesterol, VLDL-cholesterol, uric acid, and glucose levels. The data had already been collected at Lipid Research Clinics in Cincinnati, Iowa, Oklahoma, Minneapolis, and Stanford. Univariate and bivariate segregation analysis were conducted on the mode of inheritance of familial combined hyperlipidemia and familial primary hypoalphalipoproteinemia. Path analysis was used to resolve cultural and biological inheritance for each phenotype within each clinic and for resolution of population heterogeneity among the five Lipid Research Clinics. A general bivariate path model was used to analyze the associations among the various phenotypes. General models were used to analyze temporal trends in family resemblance for the seven phenotypes.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Tangier Disease, Atherosclerosis
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Tangier Disease, Atherosclerosis
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 1986
- Study completionJun 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)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
- NCT00005188
- Sponsor's protocol ID
- 1066
- Other IDs
- R01HL033973
- Status last verified
- Aug 2004
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Rao DC, Wette R. Nonrandom sampling in genetic epidemiology: maximum likelihood methods for multifactorial analysis of quantitative data ascertained through truncation. Genet Epidemiol. 1987;4(5):357-76. doi: 10.1002/gepi.1370040505.
PubMed 3319764Rao DC, Vogler GP, McGue M, Russell JM. Maximum-likelihood estimation of familial correlations from multivariate quantitative data on pedigrees: a general method and examples. Am J Hum Genet. 1987 Dec;41(6):1104-16.
PubMed 3687943Rao DC, Wette R, Ewens WJ. Multifactorial analysis of family data ascertained through truncation: a comparative evaluation of two methods of statistical inference. Am J Hum Genet. 1988 Mar;42(3):506-15.
PubMed 3348215Wette R, McGue MK, Rao DC, Cloninger CR. On the properties of maximum likelihood estimators of familial correlations under variable sibship size. Biometrics. 1988 Sep;44(3):717-25.
PubMed 3203127Province MA, Rao DC. Familial aggregation in the presence of temporal trends. Stat Med. 1988 Jan-Feb;7(1-2):185-98. doi: 10.1002/sim.4780070120.
PubMed 3258435Borecki IB, Laskarzewski P, Rao DC. Genetic factors influencing apolipoprotein AI and AII levels in a kindred with premature coronary heart disease. Genet Epidemiol. 1988;5(6):393-406. doi: 10.1002/gepi.1370050604.
PubMed 3145239Province MA, Tishler P, Rao DC. Repeated-measures model for the investigation of temporal trends using longitudinal family studies: application to systolic blood pressure. Genet Epidemiol. 1989;6(2):333-47. doi: 10.1002/gepi.1370060204.
PubMed 2721928McGue M, Wette R, Rao DC. Path analysis under generalized marital resemblance: evaluation of the assumptions underlying the mixed homogamy model by the Monte Carlo method. Genet Epidemiol. 1989;6(2):373-88. doi: 10.1002/gepi.1370060207.
PubMed 2721930Reddy BM, Rao DC. Phenylthiocarbamide taste sensitivity revisited: complete sorting test supports residual family resemblance. Genet Epidemiol. 1989;6(3):413-21. doi: 10.1002/gepi.1370060304.
PubMed 2753351Rao DC, Wette R. Nonrandom sampling in genetic epidemiology: an implementation of the Hanis-Chakraborty method for multifactorial analysis. Genet Epidemiol. 1989;6(3):461-70. doi: 10.1002/gepi.1370060308.
PubMed 2753354Perusse L, Rice T, Bouchard C, Vogler GP, Rao DC. Cardiovascular risk factors in a French-Canadian population: resolution of genetic and familial environmental effects on blood pressure by using extensive information on environmental correlates. Am J Hum Genet. 1989 Aug;45(2):240-51.
PubMed 2757030Byard PJ, Mukherjee BN, Bhattacharya SK, Russell JM, Rao DC. Familial aggregation of blood pressure and anthropometric variables in patrilocal households. Am J Phys Anthropol. 1989 Jul;79(3):305-11. doi: 10.1002/ajpa.1330790306.
PubMed 2764083McGue M, Gerrard JW, Lebowitz MD, Rao DC. Commingling in the distributions of immunoglobulin levels. Hum Hered. 1989;39(4):196-201. doi: 10.1159/000153860.
PubMed 2583731Rao DC, Wette R. Environmental index in genetic epidemiology: an investigation of its role, adequacy, and limitations. Am J Hum Genet. 1990 Jan;46(1):168-78.
PubMed 2294748Vogler GP, Wette R, Laskarzewski PM, Perry TS, Rice T, Province MA, Rao DC. Heterogeneity in the biological and cultural determinants of high-density lipoprotein cholesterol in five North American populations: the Lipid Research Clinics Family Study. Hum Hered. 1989;39(5):249-57. doi: 10.1159/000153868.
PubMed 2613250
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Genetic Analysis of Lipid Research Clinic Family Data
- ClinicalTrials.gov ID
- NCT00005188
- Acronym / sponsor ID
- 1066
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Tangier Disease, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1986
- Study completion
- Jun 1991 (actual)
- 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 assess the mode of inheritance of familial combined hyperlipidemia and familial primary hypoalphalipoproteinemia and to resolve genetic and familial environmental effects on several phenotypes of importance to coronary heart disease.
Detailed description
BACKGROUND:
Although coronary heart disease has long been known to aggregate in families, in 1986 little was known about the relative importance of genetic and environmental factors. This was partly due to the heterogeneous nature of the disease. Instead of analyzing complex endpoints, the tendency had been to focus on the individual risk factors or phenotypes. Plasma lipids and lipoproteins are heterogeneous risk factors that have been analyzed as subgroups from a genetic epidemiological perspective. Attention turned to the familial aggregation of risk factors, particularly the hyperlipidemias, hypertension, and diabetes.
In 1971, the National Heart and Lung Institute began a series of epidemiologic studies at several North American sites under the Lipid Research Clinics Program. The Family Study was designed to investigate the familial association of blood lipids, lipoproteins, and dyslipoproteinemias. This study complemented and did not duplicate ongoing analysis of Lipid Research Clinics data.
DESIGN NARRATIVE:
The study addressed seven phenotypes, all derived from fasting blood samples: total cholesterol, total triglyceride, LDL-cholesterol, HDL-cholesterol, VLDL-cholesterol, uric acid, and glucose levels. The data had already been collected at Lipid Research Clinics in Cincinnati, Iowa, Oklahoma, Minneapolis, and Stanford. Univariate and bivariate segregation analysis were conducted on the mode of inheritance of familial combined hyperlipidemia and familial primary hypoalphalipoproteinemia. Path analysis was used to resolve cultural and biological inheritance for each phenotype within each clinic and for resolution of population heterogeneity among the five Lipid Research Clinics. A general bivariate path model was used to analyze the associations among the various phenotypes. General models were used to analyze temporal trends in family resemblance for the seven phenotypes.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
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 13 May 2016.
- Background: PubMed 3319764Rao DC, Wette R. Nonrandom sampling in genetic epidemiology: maximum likelihood methods for multifactorial analysis of quantitative data ascertained through truncation. Genet Epidemiol. 1987;4(5):357-76. doi: 10.1002/gepi.1370040505.
- Background: PubMed 3687943Rao DC, Vogler GP, McGue M, Russell JM. Maximum-likelihood estimation of familial correlations from multivariate quantitative data on pedigrees: a general method and examples. Am J Hum Genet. 1987 Dec;41(6):1104-16.
- Background: PubMed 3348215Rao DC, Wette R, Ewens WJ. Multifactorial analysis of family data ascertained through truncation: a comparative evaluation of two methods of statistical inference. Am J Hum Genet. 1988 Mar;42(3):506-15.
- Background: PubMed 3203127Wette R, McGue MK, Rao DC, Cloninger CR. On the properties of maximum likelihood estimators of familial correlations under variable sibship size. Biometrics. 1988 Sep;44(3):717-25.
- Background: PubMed 3258435Province MA, Rao DC. Familial aggregation in the presence of temporal trends. Stat Med. 1988 Jan-Feb;7(1-2):185-98. doi: 10.1002/sim.4780070120.
- Background: PubMed 3145239Borecki IB, Laskarzewski P, Rao DC. Genetic factors influencing apolipoprotein AI and AII levels in a kindred with premature coronary heart disease. Genet Epidemiol. 1988;5(6):393-406. doi: 10.1002/gepi.1370050604.
- Background: PubMed 2721928Province MA, Tishler P, Rao DC. Repeated-measures model for the investigation of temporal trends using longitudinal family studies: application to systolic blood pressure. Genet Epidemiol. 1989;6(2):333-47. doi: 10.1002/gepi.1370060204.
- Background: PubMed 2721930McGue M, Wette R, Rao DC. Path analysis under generalized marital resemblance: evaluation of the assumptions underlying the mixed homogamy model by the Monte Carlo method. Genet Epidemiol. 1989;6(2):373-88. doi: 10.1002/gepi.1370060207.
- Background: PubMed 2753351Reddy BM, Rao DC. Phenylthiocarbamide taste sensitivity revisited: complete sorting test supports residual family resemblance. Genet Epidemiol. 1989;6(3):413-21. doi: 10.1002/gepi.1370060304.
- Background: PubMed 2753354Rao DC, Wette R. Nonrandom sampling in genetic epidemiology: an implementation of the Hanis-Chakraborty method for multifactorial analysis. Genet Epidemiol. 1989;6(3):461-70. doi: 10.1002/gepi.1370060308.
- Background: PubMed 2757030Perusse L, Rice T, Bouchard C, Vogler GP, Rao DC. Cardiovascular risk factors in a French-Canadian population: resolution of genetic and familial environmental effects on blood pressure by using extensive information on environmental correlates. Am J Hum Genet. 1989 Aug;45(2):240-51.
- Background: PubMed 2764083Byard PJ, Mukherjee BN, Bhattacharya SK, Russell JM, Rao DC. Familial aggregation of blood pressure and anthropometric variables in patrilocal households. Am J Phys Anthropol. 1989 Jul;79(3):305-11. doi: 10.1002/ajpa.1330790306.
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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 Heart Diseases, 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 13 May 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 NCT00005188, which also lists 24 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 13 May 2016.