Cardiovascular DiseasesNCT00005168
Hyperapo B and Coronary Heart Disease
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine the role of apolipoprotein B and apolipoprotein A1 in the etiology of coronary artery disease. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 1984to Dec 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 determine the role of apolipoprotein B and apolipoprotein A1 in the etiology of coronary artery disease.
Read the detailed description
BACKGROUND:
Hyperapo B is a phenotype defined as elevated plasma level of the major apoprotein B of low density lipoproteins in the presence of a normal plasma level of low density lipoprotein cholesterol. It has been demonstrated that hyperapo B is strongly associated with coronary artery disease. In 1984 when the study began, the independence of this association with other risk factors for coronary artery disease such as cigarette smoking, hypertension, and low plasma levels of high density lipoproteins was not known. The study improved knowledge of the pathophysiology of coronary artery disease and of the genetic and biochemical defects of hyperapo B and hypoalphalipoproteinemia.
DESIGN NARRATIVE:
Interviews were conducted and clinical data collected on each index case and spouse, as well as on first degree relatives. Risk factor data included blood pressure, blood lipid levels, obesity, cigarette smoking, fasting blood sugar and diabetes, hormone use and menopause for women, physical activity, personality scores, and family history. Clinical data included the indications for coronary arteriography, history of use of lipid-lowering agents and insulin, presence of corneal arcus, xanthomata, and xanthelasma, and the electrocardiogram.
To determine if the apolipoprotein B gene and the apolipoprotein A1-C3-A4 gene cluster were independent predictors of premature coronary disease, the relation between DNA polymeric sites within the two genes and coronary disease were investigated using cloned DNA fragments as molecular probes. To determine if apolipoprotein B and apolipoprotein A levels aggregated in families and to determine if hyperapo B and hypoalphalipoproteinemia segregated as Mendelian traits, genetic analysis was conducted in the 200 index cases and the 900 first degree relatives. Studies were also conducted on the linkages between hyperapo B and haplotypes of the apolipoprotein B gene, on hyperapo B and the Ag polymorphisms, and on hyperalphalipoproteinemia and haplotypes of the apolipoprotein A1-C3-A4 gene cluster.
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, Coronary Disease, Heart Diseases, Diabetes Mellitus, Obesity, Hypercholesterolemia, Familial
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Diabetes Mellitus, Obesity, Hyperlipoproteinemia Type II
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 startAug 1984
- Study completionDec 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)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
- NCT00005168
- Sponsor's protocol ID
- 1042
- Other IDs
- R01HL031497
- Status last verified
- May 2000
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Brunzell JD, Sniderman AD, Albers JJ, Kwiterovich PO Jr. Apoproteins B and A-I and coronary artery disease in humans. Arteriosclerosis. 1984 Mar-Apr;4(2):79-83. doi: 10.1161/01.atv.4.2.79. No abstract available.
PubMed 6422918Sniderman A, Teng B, Genest J, Cianflone K, Wacholder S, Kwiterovich P Jr. Familial aggregation and early expression of hyperapobetalipoproteinemia. Am J Cardiol. 1985 Feb 1;55(4):291-5. doi: 10.1016/0002-9149(85)90363-7.
PubMed 3969864Teng B, Sniderman A, Krauss RM, Kwiterovich PO Jr, Milne RW, Marcel YL. Modulation of apolipoprotein B antigenic determinants in human low density lipoprotein subclasses. J Biol Chem. 1985 Apr 25;260(8):5067-72.
PubMed 2580831Kwiterovich PO Jr, Bachorik PS, Franklin FA Jr, Margolis S, Georgopoulos L, Teng B, Sniderman AD. Effect of dietary treatment on the plasma levels of lipids, lipoprotein cholesterol and LDL B protein in children with type II hyperlipoproteinemia. Prog Clin Biol Res. 1985;188:123-37.
PubMed 4059254Beaty TH, Kwiterovich PO Jr, Khoury MJ, White S, Bachorik PS, Smith HH, Teng B, Sniderman A. Genetic analysis of plasma sitosterol, apoprotein B, and lipoproteins in a large Amish pedigree with sitosterolemia. Am J Hum Genet. 1986 Apr;38(4):492-504.
PubMed 3706300Genest J, Sniderman A, Cianflone K, Teng B, Wacholder S, Marcel Y, Kwiterovich P Jr. Hyperapobetalipoproteinemia. Plasma lipoprotein responses to oral fat load. Arteriosclerosis. 1986 May-Jun;6(3):297-304. doi: 10.1161/01.atv.6.3.297.
PubMed 3707428Kwiterovich P, Beaty T, Bachorik P, Chen J, Franklin F, Georgopoulos L, Sniderman A. Pediatric hyperlipoproteinemia: the phenotypic expression of hyperapobetalipoproteinemia in young probands and their parents. Prog Clin Biol Res. 1988;255:89-105.
PubMed 3340649Kwiterovich PO Jr, White S, Forte T, Bachorik PS, Smith H, Sniderman A. Hyperapobetalipoproteinemia in a kindred with familial combined hyperlipidemia and familial hypercholesterolemia. Arteriosclerosis. 1987 May-Jun;7(3):211-25. doi: 10.1161/01.atv.7.3.211.
PubMed 3593067Sniderman A, Kwiterovich PO Jr: Hyperapobetalipoproteinemia and LDL and HDL2 Heterogenity. Proceedings of the Workshop on Lipoprotein Heterogeneity, U.S. Department of Health and Human Services, NIH Publication No. 87-2646, pp 293-304, 1987
Beaty TH, Kwiterovich PO, Laville A, Lewis B. Genetic analysis of total cholesterol and triglycerides in a pedigree of St. Thomas rabbits. J Lipid Res. 1989 Mar;30(3):387-94.
PubMed 2723545Ma YH, Ladias JA, Butler R, Schumaker VN, Antonarakis SE, Lusis AJ, Heinzman C, Kwiterovich PO. Apolipoprotein B gene haplotypes. Association between Ag and DNA polymorphisms. Arteriosclerosis. 1988 Sep-Oct;8(5):521-4. doi: 10.1161/01.atv.8.5.521.
PubMed 2461193Kwiterovich PO Jr. Biochemical, clinical, genetic and metabolic studies of hyperapo-beta-lipoproteinaemia. J Inherit Metab Dis. 1988;11 Suppl 1:57-73. doi: 10.1007/BF01800571.
PubMed 3141687Kwiterovich PO Jr. HyperapoB: a pleiotropic phenotype characterized by dense low-density lipoproteins and associated with coronary artery disease. Clin Chem. 1988;34(8B):B71-7.
PubMed 3042202Bachorik PS, Kwiterovich PO Jr. Apolipoprotein measurements in clinical biochemistry and their utility vis-a-vis conventional assays. Clin Chim Acta. 1988 Nov;178(1):1-34. doi: 10.1016/0009-8981(88)90265-3.
PubMed 3067911Ladias JA, Kwiterovich PO Jr, Smith HH, Miller M, Bachorik PS, Forte T, Lusis AJ, Antonarakis SE. Apolipoprotein B-100 Hopkins (arginine4019----tryptophan). A new apolipoprotein B-100 variant in a family with premature atherosclerosis and hyperapobetalipoproteinemia. JAMA. 1989 Oct 13;262(14):1980-8. doi: 10.1001/jama.262.14.1980.
PubMed 2778934
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperapo B and Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT00005168
- Acronym / sponsor ID
- 1042
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Diabetes Mellitus, Obesity, Hypercholesterolemia, Familial
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 1984
- Study completion
- Dec 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 determine the role of apolipoprotein B and apolipoprotein A1 in the etiology of coronary artery disease.
Detailed description
BACKGROUND:
Hyperapo B is a phenotype defined as elevated plasma level of the major apoprotein B of low density lipoproteins in the presence of a normal plasma level of low density lipoprotein cholesterol. It has been demonstrated that hyperapo B is strongly associated with coronary artery disease. In 1984 when the study began, the independence of this association with other risk factors for coronary artery disease such as cigarette smoking, hypertension, and low plasma levels of high density lipoproteins was not known. The study improved knowledge of the pathophysiology of coronary artery disease and of the genetic and biochemical defects of hyperapo B and hypoalphalipoproteinemia.
DESIGN NARRATIVE:
Interviews were conducted and clinical data collected on each index case and spouse, as well as on first degree relatives. Risk factor data included blood pressure, blood lipid levels, obesity, cigarette smoking, fasting blood sugar and diabetes, hormone use and menopause for women, physical activity, personality scores, and family history. Clinical data included the indications for coronary arteriography, history of use of lipid-lowering agents and insulin, presence of corneal arcus, xanthomata, and xanthelasma, and the electrocardiogram.
To determine if the apolipoprotein B gene and the apolipoprotein A1-C3-A4 gene cluster were independent predictors of premature coronary disease, the relation between DNA polymeric sites within the two genes and coronary disease were investigated using cloned DNA fragments as molecular probes. To determine if apolipoprotein B and apolipoprotein A levels aggregated in families and to determine if hyperapo B and hypoalphalipoproteinemia segregated as Mendelian traits, genetic analysis was conducted in the 200 index cases and the 900 first degree relatives. Studies were also conducted on the linkages between hyperapo B and haplotypes of the apolipoprotein B gene, on hyperapo B and the Ag polymorphisms, and on hyperalphalipoproteinemia and haplotypes of the apolipoprotein A1-C3-A4 gene cluster.
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 18 Feb 2016.
- Background: PubMed 6422918Brunzell JD, Sniderman AD, Albers JJ, Kwiterovich PO Jr. Apoproteins B and A-I and coronary artery disease in humans. Arteriosclerosis. 1984 Mar-Apr;4(2):79-83. doi: 10.1161/01.atv.4.2.79. No abstract available.
- Background: PubMed 3969864Sniderman A, Teng B, Genest J, Cianflone K, Wacholder S, Kwiterovich P Jr. Familial aggregation and early expression of hyperapobetalipoproteinemia. Am J Cardiol. 1985 Feb 1;55(4):291-5. doi: 10.1016/0002-9149(85)90363-7.
- Background: PubMed 2580831Teng B, Sniderman A, Krauss RM, Kwiterovich PO Jr, Milne RW, Marcel YL. Modulation of apolipoprotein B antigenic determinants in human low density lipoprotein subclasses. J Biol Chem. 1985 Apr 25;260(8):5067-72.
- Background: PubMed 4059254Kwiterovich PO Jr, Bachorik PS, Franklin FA Jr, Margolis S, Georgopoulos L, Teng B, Sniderman AD. Effect of dietary treatment on the plasma levels of lipids, lipoprotein cholesterol and LDL B protein in children with type II hyperlipoproteinemia. Prog Clin Biol Res. 1985;188:123-37.
- Background: PubMed 3706300Beaty TH, Kwiterovich PO Jr, Khoury MJ, White S, Bachorik PS, Smith HH, Teng B, Sniderman A. Genetic analysis of plasma sitosterol, apoprotein B, and lipoproteins in a large Amish pedigree with sitosterolemia. Am J Hum Genet. 1986 Apr;38(4):492-504.
- Background: PubMed 3707428Genest J, Sniderman A, Cianflone K, Teng B, Wacholder S, Marcel Y, Kwiterovich P Jr. Hyperapobetalipoproteinemia. Plasma lipoprotein responses to oral fat load. Arteriosclerosis. 1986 May-Jun;6(3):297-304. doi: 10.1161/01.atv.6.3.297.
- Background: PubMed 3340649Kwiterovich P, Beaty T, Bachorik P, Chen J, Franklin F, Georgopoulos L, Sniderman A. Pediatric hyperlipoproteinemia: the phenotypic expression of hyperapobetalipoproteinemia in young probands and their parents. Prog Clin Biol Res. 1988;255:89-105.
- Background: PubMed 3593067Kwiterovich PO Jr, White S, Forte T, Bachorik PS, Smith H, Sniderman A. Hyperapobetalipoproteinemia in a kindred with familial combined hyperlipidemia and familial hypercholesterolemia. Arteriosclerosis. 1987 May-Jun;7(3):211-25. doi: 10.1161/01.atv.7.3.211.
- BackgroundSniderman A, Kwiterovich PO Jr: Hyperapobetalipoproteinemia and LDL and HDL2 Heterogenity. Proceedings of the Workshop on Lipoprotein Heterogeneity, U.S. Department of Health and Human Services, NIH Publication No. 87-2646, pp 293-304, 1987
- Background: PubMed 2723545Beaty TH, Kwiterovich PO, Laville A, Lewis B. Genetic analysis of total cholesterol and triglycerides in a pedigree of St. Thomas rabbits. J Lipid Res. 1989 Mar;30(3):387-94.
- Background: PubMed 2461193Ma YH, Ladias JA, Butler R, Schumaker VN, Antonarakis SE, Lusis AJ, Heinzman C, Kwiterovich PO. Apolipoprotein B gene haplotypes. Association between Ag and DNA polymorphisms. Arteriosclerosis. 1988 Sep-Oct;8(5):521-4. doi: 10.1161/01.atv.8.5.521.
- Background: PubMed 3141687Kwiterovich PO Jr. Biochemical, clinical, genetic and metabolic studies of hyperapo-beta-lipoproteinaemia. J Inherit Metab Dis. 1988;11 Suppl 1:57-73. doi: 10.1007/BF01800571.
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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 Coronary Disease, 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 18 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 NCT00005168, which also lists 27 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 18 Feb 2016.