Cardiovascular DiseasesNCT00005364
Genetic Epidemiology of CHD Risk Factors in Blacks
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine the genetic epidemiology of coronary heart disease (CHD) risk factors in Blacks. 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
- Apr 1994to Mar 1999
- 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 genetic epidemiology of coronary heart disease (CHD) risk factors in Blacks.
Read the detailed description
DESIGN NARRATIVE:
The study used two well defined African populations from Nigeria to determine the contribution of 14 polymorphic genes involved in lipid metabolism in determining quantitative lipoprotein-lipid and apolipoprotein levels as these are major risk factors for coronary heart disease. The study also investigated how differences in life styles and dietary habits modulate the genetic contribution of these quantitative risk factors. Phenotypes in the gene products of APOs A-IV, C-II, D, H, J and (a) were determined by IEF and SDS/immunoblotting. Genotypes at the B,E, AI-CIII- AIV cluster, lipoprotein lipase, hepatic lipase, LDL-receptor, and cholesterol ester transfer protein were determined by polymerase chain reaction protocols. The quantitative levels of total cholesterol, HDL-cholesterol and its subfractions, HDL2- and HDL3-cholesterol, triglycerides and LP(a) were used in the genetic analyses. Estimates of the effect of alleles at each of the candidate loci on quantitative lipoprotein-lipid levels employed the measured genotype approach. The effect of multisite haplotypes for RFLP at various loci, where applicable, was also estimated using the same method. The interaction of alleles at various independent loci in determining quantitative lipoprotein-lipid and apolipoprotein levels was estimated. In addition to the measurements of environmental effects, measurements were also made of the genotype-environmental interaction in determining quantitative risk factor traits.
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
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
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 startApr 1994
- Study completionMar 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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
- NCT00005364
- Sponsor's protocol ID
- 4251
- Other IDs
- R01HL049074
- Status last verified
- Jun 2000
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Anderson JL, Bunker CH, Aston CE, Kamboh MI. Relationship of two apolipoprotein B polymorphisms with serum lipoprotein and lipid levels in African blacks. Hum Biol. 1997 Dec;69(6):793-807.
PubMed 9353975Saha N, Wang G, Vasisht S, Kamboh MI. Influence of two apo A4 polymorphisms at codons 347 and 360 on non-fasting plasma lipoprotein-lipids and apolipoproteins in Asian Indians. Atherosclerosis. 1997 Jun;131(2):249-55. doi: 10.1016/s0021-9150(97)06112-1.
PubMed 9199279Kamboh MI, Sanghera DK, Aston CE, Bunker CH, Hamman RF, Ferrell RE, DeKosky ST. Gender-specific nonrandom association between the alpha 1-antichymotrypsin and apolipoprotein E polymorphisms in the general population and its implication for the risk of Alzheimer's disease. Genet Epidemiol. 1997;14(2):169-80. doi: 10.1002/(SICI)1098-2272(1997)14:23.0.CO;2-2.
PubMed 9129962Sanghera DK, Saha N, Aston CE, Kamboh MI. Genetic polymorphism of paraoxonase and the risk of coronary heart disease. Arterioscler Thromb Vasc Biol. 1997 Jun;17(6):1067-73. doi: 10.1161/01.atv.17.6.1067.
PubMed 9194756Evans RW, Sankey SS, Hauth BA, Sutton-Tyrrell K, Kamboh MI, Kuller LH. Effect of sample storage on quantitation of lipoprotein(a) by an enzyme-linked immunosorbent assay. Lipids. 1996 Nov;31(11):1197-203. doi: 10.1007/BF02524295.
PubMed 8934453Harris M, Sanghera DK, Kamboh MI. Short report on DNA marker at candidate locus. Two new alleles in the tetranucleotide repeat polymorphism in the LDL-receptor-related protein (LRP) gene. Clin Genet. 1996 Jul;50(1):54-5. No abstract available.
PubMed 8891388Kamboh MI, Evans RW, Aston CE. Genetic effect of apolipoprotein(a) and apolipoprotein E polymorphisms on plasma quantitative risk factors for coronary heart disease in American black women. Atherosclerosis. 1995 Sep;117(1):73-81. doi: 10.1016/0021-9150(95)05559-f.
PubMed 8546757Kamboh MI, Aston CE, Hamman RF. The relationship of APOE polymorphism and cholesterol levels in normoglycemic and diabetic subjects in a biethnic population from the San Luis Valley, Colorado. Atherosclerosis. 1995 Jan 20;112(2):145-59. doi: 10.1016/0021-9150(94)05409-c.
PubMed 7772075Islam S, Gutin B, Smith C, Treiber F, Kamboh MI. Association of apolipoprotein(a) phenotypes in children with family history of premature coronary artery disease. Arterioscler Thromb. 1994 Oct;14(10):1609-16. doi: 10.1161/01.atv.14.10.1609.
PubMed 7918311Sanghera DK, Aston CE, Saha N, Kamboh MI. DNA polymorphisms in two paraoxonase genes (PON1 and PON2) are associated with the risk of coronary heart disease. Am J Hum Genet. 1998 Jan;62(1):36-44. doi: 10.1086/301669.
PubMed 9443862Sanghera DK, Saha N, Kamboh MI. The codon 55 polymorphism in the paraoxonase 1 gene is not associated with the risk of coronary heart disease in Asian Indians and Chinese. Atherosclerosis. 1998 Feb;136(2):217-23. doi: 10.1016/s0021-9150(97)00206-2.
PubMed 9543091Ali S, Bunker CH, Aston CE, Ukoli FA, Kamboh MI. Apolipoprotein A kringle 4 polymorphism and serum lipoprotein (a) concentrations in African blacks. Hum Biol. 1998 Jun;70(3):477-90.
PubMed 9599940Harris MR, Bunker CH, Hamman RF, Sanghera DK, Aston CE, Kamboh MI. Racial differences in the distribution of a low density lipoprotein receptor-related protein (LRP) polymorphism and its association with serum lipoprotein, lipid and apolipoprotein levels. Atherosclerosis. 1998 Mar;137(1):187-95. doi: 10.1016/s0021-9150(97)00230-x.
PubMed 9568751Nestlerode CS, Bunker CH, Sanghera DK, Aston CE, Ukoli FA, Kamboh MI. Apolipoprotein J polymorphisms and serum HDL cholesterol levels in African blacks. Hum Biol. 1999 Apr;71(2):197-218.
PubMed 10222643Kamboh MI, Bunker CH, Aston CE, Nestlerode CS, McAllister AE, Ukoli FA. Genetic association of five apolipoprotein polymorphisms with serum lipoprotein-lipid levels in African blacks. Genet Epidemiol. 1999;16(2):205-22. doi: 10.1002/(SICI)1098-2272(1999)16:23.0.CO;2-P.
PubMed 10030402
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
- Genetic Epidemiology of CHD Risk Factors in Blacks
- ClinicalTrials.gov ID
- NCT00005364
- Acronym / sponsor ID
- 4251
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 1994
- Study completion
- Mar 1999 (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 genetic epidemiology of coronary heart disease (CHD) risk factors in Blacks.
Detailed description
DESIGN NARRATIVE:
The study used two well defined African populations from Nigeria to determine the contribution of 14 polymorphic genes involved in lipid metabolism in determining quantitative lipoprotein-lipid and apolipoprotein levels as these are major risk factors for coronary heart disease. The study also investigated how differences in life styles and dietary habits modulate the genetic contribution of these quantitative risk factors. Phenotypes in the gene products of APOs A-IV, C-II, D, H, J and (a) were determined by IEF and SDS/immunoblotting. Genotypes at the B,E, AI-CIII- AIV cluster, lipoprotein lipase, hepatic lipase, LDL-receptor, and cholesterol ester transfer protein were determined by polymerase chain reaction protocols. The quantitative levels of total cholesterol, HDL-cholesterol and its subfractions, HDL2- and HDL3-cholesterol, triglycerides and LP(a) were used in the genetic analyses. Estimates of the effect of alleles at each of the candidate loci on quantitative lipoprotein-lipid levels employed the measured genotype approach. The effect of multisite haplotypes for RFLP at various loci, where applicable, was also estimated using the same method. The interaction of alleles at various independent loci in determining quantitative lipoprotein-lipid and apolipoprotein levels was estimated. In addition to the measurements of environmental effects, measurements were also made of the genotype-environmental interaction in determining quantitative risk factor traits.
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 9353975Anderson JL, Bunker CH, Aston CE, Kamboh MI. Relationship of two apolipoprotein B polymorphisms with serum lipoprotein and lipid levels in African blacks. Hum Biol. 1997 Dec;69(6):793-807.
- Background: PubMed 9199279Saha N, Wang G, Vasisht S, Kamboh MI. Influence of two apo A4 polymorphisms at codons 347 and 360 on non-fasting plasma lipoprotein-lipids and apolipoproteins in Asian Indians. Atherosclerosis. 1997 Jun;131(2):249-55. doi: 10.1016/s0021-9150(97)06112-1.
- Background: PubMed 9129962Kamboh MI, Sanghera DK, Aston CE, Bunker CH, Hamman RF, Ferrell RE, DeKosky ST. Gender-specific nonrandom association between the alpha 1-antichymotrypsin and apolipoprotein E polymorphisms in the general population and its implication for the risk of Alzheimer's disease. Genet Epidemiol. 1997;14(2):169-80. doi: 10.1002/(SICI)1098-2272(1997)14:23.0.CO;2-2.
- Background: PubMed 9194756Sanghera DK, Saha N, Aston CE, Kamboh MI. Genetic polymorphism of paraoxonase and the risk of coronary heart disease. Arterioscler Thromb Vasc Biol. 1997 Jun;17(6):1067-73. doi: 10.1161/01.atv.17.6.1067.
- Background: PubMed 8934453Evans RW, Sankey SS, Hauth BA, Sutton-Tyrrell K, Kamboh MI, Kuller LH. Effect of sample storage on quantitation of lipoprotein(a) by an enzyme-linked immunosorbent assay. Lipids. 1996 Nov;31(11):1197-203. doi: 10.1007/BF02524295.
- Background: PubMed 8891388Harris M, Sanghera DK, Kamboh MI. Short report on DNA marker at candidate locus. Two new alleles in the tetranucleotide repeat polymorphism in the LDL-receptor-related protein (LRP) gene. Clin Genet. 1996 Jul;50(1):54-5. No abstract available.
- Background: PubMed 8546757Kamboh MI, Evans RW, Aston CE. Genetic effect of apolipoprotein(a) and apolipoprotein E polymorphisms on plasma quantitative risk factors for coronary heart disease in American black women. Atherosclerosis. 1995 Sep;117(1):73-81. doi: 10.1016/0021-9150(95)05559-f.
- Background: PubMed 7772075Kamboh MI, Aston CE, Hamman RF. The relationship of APOE polymorphism and cholesterol levels in normoglycemic and diabetic subjects in a biethnic population from the San Luis Valley, Colorado. Atherosclerosis. 1995 Jan 20;112(2):145-59. doi: 10.1016/0021-9150(94)05409-c.
- Background: PubMed 7918311Islam S, Gutin B, Smith C, Treiber F, Kamboh MI. Association of apolipoprotein(a) phenotypes in children with family history of premature coronary artery disease. Arterioscler Thromb. 1994 Oct;14(10):1609-16. doi: 10.1161/01.atv.14.10.1609.
- Background: PubMed 9443862Sanghera DK, Aston CE, Saha N, Kamboh MI. DNA polymorphisms in two paraoxonase genes (PON1 and PON2) are associated with the risk of coronary heart disease. Am J Hum Genet. 1998 Jan;62(1):36-44. doi: 10.1086/301669.
- Background: PubMed 9543091Sanghera DK, Saha N, Kamboh MI. The codon 55 polymorphism in the paraoxonase 1 gene is not associated with the risk of coronary heart disease in Asian Indians and Chinese. Atherosclerosis. 1998 Feb;136(2):217-23. doi: 10.1016/s0021-9150(97)00206-2.
- Background: PubMed 9599940Ali S, Bunker CH, Aston CE, Ukoli FA, Kamboh MI. Apolipoprotein A kringle 4 polymorphism and serum lipoprotein (a) concentrations in African blacks. Hum Biol. 1998 Jun;70(3):477-90.
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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 NCT00005364, which also lists 16 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.