Cardiovascular DiseasesNCT00005186
Epidemiology of Cardiovascular Diseases in The Elderly
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To identify and describe the distribution of risk factors for cardiovascular disease in a cohort of free-living elderly persons. 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
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1986to Jun 1992
- 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 identify and describe the distribution of risk factors for cardiovascular disease in a cohort of free-living elderly persons.
Read the detailed description
BACKGROUND:
Cardiovascular disease is the leading cause of mortality in older persons in the United States. Nearly two-thirds of all deaths in men and women 65 years of age or older are due to some manifestation of cardiovascular disease. Further, cardiovascular disease is a major cause of disability in the elderly. Although there is relatively extensive epidemiologic data on risk factors for cardiovascular disease in younger individuals, particularly younger men, in 1986 when the study was initiated, relatively little information existed on the prevalence and antecedents of cardiovascular disease in men and women over 65 years of age. Further, the data that did exist tended to be contradictory. From a public health perspective, it was important to identify risk factors for cardiovascular disease in older individuals for several reasons. The numbers and proportion of elderly persons in the U.S. were growing, and would continue to grow well into the next century. This segment of our society, which comprised 12 percent of the population in 1986, accounted for one third of our health care costs. Older Americans will continue to make significant demands on the health care system in the coming decades. The identification of risk factors for this major public health problem (e.g., cardiovascular disease) may lead to interventions which would improve the health of older Americans and thus benefit the entire society.
Data for this project have been gathered since 1975 by the Dunedin Program, a population-based geriatric health-screening program. This Program was designed to screen persons 65 years of age or older for a wide variety of medical disorders. It was situated in Dunedin, Florida, which is on the mid-west Gulf coast. Each participant was seen at the clinic once a year. The clinic visit consisted of registration, a physical examination, and questionnaire/medication form. Data were available on family history of illnesses, illnesses of participant, smoking history, alcohol use, emotional status, coffee consumption, dietary habits, current symptoms, social activities, exercise, attitudes towards health care, height, weight, blood pressure, carotid artery auscultation, electrocardiogram, lipid levels, blood chemistries and blood counts, diabetes, urine samples, and medication use. In 1986, a total of 5,085 persons had completed the first screening examination and 1,540 had completed a full eight years of screening.
DESIGN NARRATIVE:
In the first phase, follow-up time for each participant was computed and changes in risk factor status analyzed. Cardiovascular disease incidence and mortality rates were calculated. In the second phase, incidence rates of cardiovascular disease were computed by category of risk factor level at baseline. The relative risk of cardiovascular disease was calculated for each risk factor. Multivariable analyses were carried out in the third phase. Regression models were used to determine independent and interactive effects of the identified risk factors on the incidence of and mortality from cardiovascular disease.
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
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
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 1986
- Study completionJun 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Investigators
- Trudy Bush, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005186
- Sponsor's protocol ID
- 1064
- Other IDs
- R23HL038628
- Status last verified
- Mar 2005
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Sorock GS, Bush TL, Golden AL, Fried LP, Breuer B, Hale WE. Physical activity and fracture risk in a free-living elderly cohort. J Gerontol. 1988 Sep;43(5):M134-9. doi: 10.1093/geronj/43.5.m134.
PubMed 3418034Fried LP, Bush TL. Morbidity as a focus of preventive health care in the elderly. Epidemiol Rev. 1988;10:48-64. doi: 10.1093/oxfordjournals.epirev.a036028.
PubMed 3066630Bush TL, Miller SR, Golden AL, Hale WE. Self-report and medical record report agreement of selected medical conditions in the elderly. Am J Public Health. 1989 Nov;79(11):1554-6. doi: 10.2105/ajph.79.11.1554.
PubMed 2817172Maggi S, Bush TL, Hale WE. Diabetes mellitus and other cardiovascular risk factors in an elderly population. Age Ageing. 1990 May;19(3):173-8. doi: 10.1093/ageing/19.3.173.
PubMed 2363377Newschaffer CJ, Bush TL, Hale WE. Aging and total cholesterol levels: cohort, period, and survivorship effects. Am J Epidemiol. 1992 Jul 1;136(1):23-34. doi: 10.1093/oxfordjournals.aje.a116417.
PubMed 1415129
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
- Epidemiology of Cardiovascular Diseases in The Elderly
- ClinicalTrials.gov ID
- NCT00005186
- Acronym / sponsor ID
- 1064
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 1986
- Study completion
- Jun 1992 (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 identify and describe the distribution of risk factors for cardiovascular disease in a cohort of free-living elderly persons.
Detailed description
BACKGROUND:
Cardiovascular disease is the leading cause of mortality in older persons in the United States. Nearly two-thirds of all deaths in men and women 65 years of age or older are due to some manifestation of cardiovascular disease. Further, cardiovascular disease is a major cause of disability in the elderly. Although there is relatively extensive epidemiologic data on risk factors for cardiovascular disease in younger individuals, particularly younger men, in 1986 when the study was initiated, relatively little information existed on the prevalence and antecedents of cardiovascular disease in men and women over 65 years of age. Further, the data that did exist tended to be contradictory. From a public health perspective, it was important to identify risk factors for cardiovascular disease in older individuals for several reasons. The numbers and proportion of elderly persons in the U.S. were growing, and would continue to grow well into the next century. This segment of our society, which comprised 12 percent of the population in 1986, accounted for one third of our health care costs. Older Americans will continue to make significant demands on the health care system in the coming decades. The identification of risk factors for this major public health problem (e.g., cardiovascular disease) may lead to interventions which would improve the health of older Americans and thus benefit the entire society.
Data for this project have been gathered since 1975 by the Dunedin Program, a population-based geriatric health-screening program. This Program was designed to screen persons 65 years of age or older for a wide variety of medical disorders. It was situated in Dunedin, Florida, which is on the mid-west Gulf coast. Each participant was seen at the clinic once a year. The clinic visit consisted of registration, a physical examination, and questionnaire/medication form. Data were available on family history of illnesses, illnesses of participant, smoking history, alcohol use, emotional status, coffee consumption, dietary habits, current symptoms, social activities, exercise, attitudes towards health care, height, weight, blood pressure, carotid artery auscultation, electrocardiogram, lipid levels, blood chemistries and blood counts, diabetes, urine samples, and medication use. In 1986, a total of 5,085 persons had completed the first screening examination and 1,540 had completed a full eight years of screening.
DESIGN NARRATIVE:
In the first phase, follow-up time for each participant was computed and changes in risk factor status analyzed. Cardiovascular disease incidence and mortality rates were calculated. In the second phase, incidence rates of cardiovascular disease were computed by category of risk factor level at baseline. The relative risk of cardiovascular disease was calculated for each risk factor. Multivariable analyses were carried out in the third phase. Regression models were used to determine independent and interactive effects of the identified risk factors on the incidence of and mortality from cardiovascular disease.
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 3418034Sorock GS, Bush TL, Golden AL, Fried LP, Breuer B, Hale WE. Physical activity and fracture risk in a free-living elderly cohort. J Gerontol. 1988 Sep;43(5):M134-9. doi: 10.1093/geronj/43.5.m134.
- Background: PubMed 3066630Fried LP, Bush TL. Morbidity as a focus of preventive health care in the elderly. Epidemiol Rev. 1988;10:48-64. doi: 10.1093/oxfordjournals.epirev.a036028.
- Background: PubMed 2817172Bush TL, Miller SR, Golden AL, Hale WE. Self-report and medical record report agreement of selected medical conditions in the elderly. Am J Public Health. 1989 Nov;79(11):1554-6. doi: 10.2105/ajph.79.11.1554.
- Background: PubMed 2363377Maggi S, Bush TL, Hale WE. Diabetes mellitus and other cardiovascular risk factors in an elderly population. Age Ageing. 1990 May;19(3):173-8. doi: 10.1093/ageing/19.3.173.
- Background: PubMed 1415129Newschaffer CJ, Bush TL, Hale WE. Aging and total cholesterol levels: cohort, period, and survivorship effects. Am J Epidemiol. 1992 Jul 1;136(1):23-34. doi: 10.1093/oxfordjournals.aje.a116417.
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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.
Trudy Bush
Johns Hopkins University
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 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 NCT00005186, which also lists 5 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.