Cardiovascular DiseasesNCT00005223
Epidemiology of APO- and Lipoproteins in Elderly Women
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To examine the complex interactions among the traditional cardiovascular risk factors, particularly lipoprotein and apoprotein levels, genetic and other characteristics, and lifestyle habits in elderly women. 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 1988to Mar 1993
- 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 examine the complex interactions among the traditional cardiovascular risk factors, particularly lipoprotein and apoprotein levels, genetic and other characteristics, and lifestyle habits in elderly women.
Read the detailed description
BACKGROUND:
Coronary heart disease is the leading cause of death in both men and women 65 years of age and older, and in 1982, it was estimated that it accounted for about 32.4 percent of all deaths in this age group and may have contributed to death in an additional 12.1 percent. Coronary heart disease mortality rates increase steeply with age, even in those over 65 years of age. Death rates for males continue to be higher than females although the sex ratio declined sharply with age. Data from Framingham suggest that although the incidence of coronary heart disease rises with age in both males and females, the incidence rate rises more steeply in elderly females compared with elderly males. Despite the magnitude of this problem, in 1988 the majority of the knowledge on coronary heart disease and its risk factors related to the disease in middle-aged persons--primarily males. More information was needed about coronary heart disease and its risk factors in elderly women. Also, the atherosclerotic process develops over many years and the risk factors which relate to the evolution of atherosclerosis are highly correlated within an individual. Therefore, it is likely that risk factors, such as lipoproteins and apoproteins will be important determinants of coronary heart disease in older persons primarily because of this observed correlation within individuals over time, and their long-term association with the development and progression of atherosclerosis. In addition, identification of the high risk individual is a goal of many epidemiologic investigations. It is possible that qualitative examination of the polymorphisms of the apoproteins could in fact assist in the identification of women at high risk of coronary heart disease who are in need of aggressive prophylaxis. These genetic markers represent a second generation of risk factors for coronary heart disease.
DESIGN NARRATIVE:
The study was ancillary to the multicenter Study of Osteoporotic Fractures (SOF), a prospective study on risk factors for hip and wrist fractures supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The cross-sectional study involved a sample of subjects at the Pittsburgh Center. The distribution and interrelationships of lipoproteins and apoproteins were described as were their relationships to age, years since menopause, type of menopause, and lifestyle factors such as physical activity, alcohol consumption, cigarette smoking, obesity, and use of estrogens/progestins. The frequency of phenotypes of the polymorphisms of apoprotein A-IV and E were examined to determine whether these phenotypes were associated with specific patterns of lipo- and apoproteins. The hypothesis was tested that the degree to which lifestyle characteristics explain the variability in lipoproteins and apoproteins depended on the genetic makeup of the individual.
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 1988
- Study completionMar 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- NCT00005223
- Sponsor's protocol ID
- 1102
- Other IDs
- R29HL040489
- Status last verified
- Apr 2001
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Vogt MT, Cauley JA, Kuller LH, Nevitt MC. Bone mineral density and blood flow to the lower extremities: the study of osteoporotic fractures. J Bone Miner Res. 1997 Feb;12(2):283-9. doi: 10.1359/jbmr.1997.12.2.283.
PubMed 9041062Vogt MT, Cauley JA, Kuller LH. Apolipoprotein E phenotype, arterial disease, and mortality among older women: the study of osteoporotic fractures. Genet Epidemiol. 1997;14(2):147-56. doi: 10.1002/(SICI)1098-2272(1997)14:23.0.CO;2-4.
PubMed 9129960Vogt MT, Nevitt MC, Cauley JA. Back problems and atherosclerosis. The Study of Osteoporotic Fractures. Spine (Phila Pa 1976). 1997 Dec 1;22(23):2741-7. doi: 10.1097/00007632-199712010-00008.
PubMed 9431608Cauley JA, Gutai JP, Kuller LH, Powell JG. The relation of endogenous sex steroid hormone concentrations to serum lipid and lipoprotein levels in postmenopausal women. Am J Epidemiol. 1990 Nov;132(5):884-94. doi: 10.1093/oxfordjournals.aje.a115731.
PubMed 2239903Vogt MT, Cauley JA, Kuller LH, Nevitt MC. Functional status and mobility among elderly women with lower extremity arterial disease: the Study of Osteoporotic Fractures. J Am Geriatr Soc. 1994 Sep;42(9):923-9. doi: 10.1111/j.1532-5415.1994.tb06581.x.
PubMed 8064098Danielson ME, Cauley JA, Rohay JM. Physical activity and its association with plasma lipids and lipoproteins in elderly women. Ann Epidemiol. 1993 Jul;3(4):351-7. doi: 10.1016/1047-2797(93)90061-8.
PubMed 8275210Cauley JA, Gutai JP, Glynn NW, Paternostro-Bayles M, Cottington E, Kuller LH. Serum estrone concentrations and coronary artery disease in postmenopausal women. Arterioscler Thromb. 1994 Jan;14(1):14-8. doi: 10.1161/01.atv.14.1.14.
PubMed 8274469Carson CA, Cauley JA, Caggiula AW. Relation of caffeine intake to blood lipids in elderly women. Am J Epidemiol. 1993 Jul 15;138(2):94-100. doi: 10.1093/oxfordjournals.aje.a116839.
PubMed 8342534Vogt MT, Cauley JA, Newman AB, Kuller LH, Hulley SB. Decreased ankle/arm blood pressure index and mortality in elderly women. JAMA. 1993 Jul 28;270(4):465-9.
PubMed 8320785Cauley JA, Eichner JE, Kamboh MI, Ferrell RE, Kuller LH. Apo E allele frequencies in younger (age 42-50) vs older (age 65-90) women. Genet Epidemiol. 1993;10(1):27-34. doi: 10.1002/gepi.1370100104.
PubMed 8472931Vogt MT, Cauley JA, Kuller LH, Hulley SB. Prevalence and correlates of lower extremity arterial disease in elderly women. Am J Epidemiol. 1993 Mar 1;137(5):559-68. doi: 10.1093/oxfordjournals.aje.a116709.
PubMed 8465807Ganguli M, Cauley JA, DeKosky ST, Kamboh MI. Dementia among elderly apolipoprotein E type 4/4 homozygotes: a prospective study. Genet Epidemiol. 1995;12(3):309-11. doi: 10.1002/gepi.1370120308.
PubMed 7557352Cauley JA, Zmuda JM, Yaffe K, Kuller LH, Ferrell RE, Wisniewski SR, Cummings SR. Apolipoprotein E polymorphism: A new genetic marker of hip fracture risk--The Study of Osteoporotic Fractures. J Bone Miner Res. 1999 Jul;14(7):1175-81. doi: 10.1359/jbmr.1999.14.7.1175.
PubMed 10404018
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
- Epidemiology of APO- and Lipoproteins in Elderly Women
- ClinicalTrials.gov ID
- NCT00005223
- Acronym / sponsor ID
- 1102
- 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 1988
- Study completion
- Mar 1993 (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 examine the complex interactions among the traditional cardiovascular risk factors, particularly lipoprotein and apoprotein levels, genetic and other characteristics, and lifestyle habits in elderly women.
Detailed description
BACKGROUND:
Coronary heart disease is the leading cause of death in both men and women 65 years of age and older, and in 1982, it was estimated that it accounted for about 32.4 percent of all deaths in this age group and may have contributed to death in an additional 12.1 percent. Coronary heart disease mortality rates increase steeply with age, even in those over 65 years of age. Death rates for males continue to be higher than females although the sex ratio declined sharply with age. Data from Framingham suggest that although the incidence of coronary heart disease rises with age in both males and females, the incidence rate rises more steeply in elderly females compared with elderly males. Despite the magnitude of this problem, in 1988 the majority of the knowledge on coronary heart disease and its risk factors related to the disease in middle-aged persons--primarily males. More information was needed about coronary heart disease and its risk factors in elderly women. Also, the atherosclerotic process develops over many years and the risk factors which relate to the evolution of atherosclerosis are highly correlated within an individual. Therefore, it is likely that risk factors, such as lipoproteins and apoproteins will be important determinants of coronary heart disease in older persons primarily because of this observed correlation within individuals over time, and their long-term association with the development and progression of atherosclerosis. In addition, identification of the high risk individual is a goal of many epidemiologic investigations. It is possible that qualitative examination of the polymorphisms of the apoproteins could in fact assist in the identification of women at high risk of coronary heart disease who are in need of aggressive prophylaxis. These genetic markers represent a second generation of risk factors for coronary heart disease.
DESIGN NARRATIVE:
The study was ancillary to the multicenter Study of Osteoporotic Fractures (SOF), a prospective study on risk factors for hip and wrist fractures supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The cross-sectional study involved a sample of subjects at the Pittsburgh Center. The distribution and interrelationships of lipoproteins and apoproteins were described as were their relationships to age, years since menopause, type of menopause, and lifestyle factors such as physical activity, alcohol consumption, cigarette smoking, obesity, and use of estrogens/progestins. The frequency of phenotypes of the polymorphisms of apoprotein A-IV and E were examined to determine whether these phenotypes were associated with specific patterns of lipo- and apoproteins. The hypothesis was tested that the degree to which lifestyle characteristics explain the variability in lipoproteins and apoproteins depended on the genetic makeup of the individual.
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 9041062Vogt MT, Cauley JA, Kuller LH, Nevitt MC. Bone mineral density and blood flow to the lower extremities: the study of osteoporotic fractures. J Bone Miner Res. 1997 Feb;12(2):283-9. doi: 10.1359/jbmr.1997.12.2.283.
- Background: PubMed 9129960Vogt MT, Cauley JA, Kuller LH. Apolipoprotein E phenotype, arterial disease, and mortality among older women: the study of osteoporotic fractures. Genet Epidemiol. 1997;14(2):147-56. doi: 10.1002/(SICI)1098-2272(1997)14:23.0.CO;2-4.
- Background: PubMed 9431608Vogt MT, Nevitt MC, Cauley JA. Back problems and atherosclerosis. The Study of Osteoporotic Fractures. Spine (Phila Pa 1976). 1997 Dec 1;22(23):2741-7. doi: 10.1097/00007632-199712010-00008.
- Background: PubMed 2239903Cauley JA, Gutai JP, Kuller LH, Powell JG. The relation of endogenous sex steroid hormone concentrations to serum lipid and lipoprotein levels in postmenopausal women. Am J Epidemiol. 1990 Nov;132(5):884-94. doi: 10.1093/oxfordjournals.aje.a115731.
- Background: PubMed 8064098Vogt MT, Cauley JA, Kuller LH, Nevitt MC. Functional status and mobility among elderly women with lower extremity arterial disease: the Study of Osteoporotic Fractures. J Am Geriatr Soc. 1994 Sep;42(9):923-9. doi: 10.1111/j.1532-5415.1994.tb06581.x.
- Background: PubMed 8275210Danielson ME, Cauley JA, Rohay JM. Physical activity and its association with plasma lipids and lipoproteins in elderly women. Ann Epidemiol. 1993 Jul;3(4):351-7. doi: 10.1016/1047-2797(93)90061-8.
- Background: PubMed 8274469Cauley JA, Gutai JP, Glynn NW, Paternostro-Bayles M, Cottington E, Kuller LH. Serum estrone concentrations and coronary artery disease in postmenopausal women. Arterioscler Thromb. 1994 Jan;14(1):14-8. doi: 10.1161/01.atv.14.1.14.
- Background: PubMed 8342534Carson CA, Cauley JA, Caggiula AW. Relation of caffeine intake to blood lipids in elderly women. Am J Epidemiol. 1993 Jul 15;138(2):94-100. doi: 10.1093/oxfordjournals.aje.a116839.
- Background: PubMed 8320785Vogt MT, Cauley JA, Newman AB, Kuller LH, Hulley SB. Decreased ankle/arm blood pressure index and mortality in elderly women. JAMA. 1993 Jul 28;270(4):465-9.
- Background: PubMed 8472931Cauley JA, Eichner JE, Kamboh MI, Ferrell RE, Kuller LH. Apo E allele frequencies in younger (age 42-50) vs older (age 65-90) women. Genet Epidemiol. 1993;10(1):27-34. doi: 10.1002/gepi.1370100104.
- Background: PubMed 8465807Vogt MT, Cauley JA, Kuller LH, Hulley SB. Prevalence and correlates of lower extremity arterial disease in elderly women. Am J Epidemiol. 1993 Mar 1;137(5):559-68. doi: 10.1093/oxfordjournals.aje.a116709.
- Background: PubMed 7557352Ganguli M, Cauley JA, DeKosky ST, Kamboh MI. Dementia among elderly apolipoprotein E type 4/4 homozygotes: a prospective study. Genet Epidemiol. 1995;12(3):309-11. doi: 10.1002/gepi.1370120308.
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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 NCT00005223, which also lists 13 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.