Cardiovascular DiseasesNCT00006296
CV Risk Factors at Age 25-64 & Long-Term Medicare Costs
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To assess in four large Chicago population cohorts whether young adult and middle-aged risk factor status has an impact not only on average annual Medicare costs, but also on cumulative and lifetime Medicare costs, to ages 70, 75, 80, >80, including to death, and during the last one to two years of life. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2000to Jul 2005
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
About this study
To assess in four large Chicago population cohorts whether young adult and middle-aged risk factor status has an impact not only on average annual Medicare costs, but also on cumulative and lifetime Medicare costs, to ages 70, 75, 80, >80, including to death, and during the last one to two years of life.
Read the detailed description
BACKGROUND:
Studies will be conducted on the cumulative lifetime Medicare costs of individuals from four Chicago population cohorts from which prior risk factor data are available. One cohort is from the Western Electric Company Study, with 2107 men who were 40-56 when the follow up began in 1957. For this group a physical exam, ECG and cholesterol measures are available along with data from a quantitative diet history conducted at that time assessing 28 days of intake. It is not clear whether the men themselves or their wives provided this information. Repeat measures are available, but attention is paid to their use in the analyses. Also, information on the availability of the quantitative information at the food level is not provided. Two cohorts are from the Peoples Gas Company Study, one with 1594 men aged 40-59 in 1958 and the second with 1609 men aged 25-39 in 1959 . From both cohorts a total of 1802 men are, based on their ages, currently Medicare eligible.The fourth cohort is the Chicago Heart Disease Detection Association Project (CHA) based on an initial survey of 39,573 men and women conducted in 1967-1973 on whom dietary data are not available.
DESIGN NARRATIVE:
The study assesses the relationships of CVD risk factors measured in young and middle-aged adult men and women to Medicare utilization and charges, from Medicare enrollment to death or attainment of age 70, 75, 80, >80, including in the last one to two years of life. The study determines long-term relationship between earlier low-risk status vs. not-low-risk to subsequent Medicare health care charges. Baseline low risk is all six CVD risk factors favorable: systolic/diastolic pressure 120 mmHg/80 mmHg and no antihypertensive treatment, serum cholesterol <200 mg/dl, not currently smoking, no ECG abnormalities, no history of diabetes or heart attack. The study also determines the relationships between baseline habitual eating patterns and subsequent Medicare utilization and charges. Further statistical methods are developed for optimal analyses of health care expenditures. The database will be extended by obtaining additional years of morbidity-mortality experience and of Medicare charge data to the year 2002.
- 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 Sep 2000 (estimated)
- Study startSep 2000
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Martha Daviglus, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006296
- Sponsor's protocol ID
- 913
- Other IDs
- R01HL062684
- Status last verified
- Apr 2009
- First submitted
- 25 Sep 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Daviglus ML, Liu K, Pirzada A, Yan LL, Garside DB, Feinglass J, Guralnik JM, Greenland P, Stamler J. Favorable cardiovascular risk profile in middle age and health-related quality of life in older age. Arch Intern Med. 2003 Nov 10;163(20):2460-8. doi: 10.1001/archinte.163.20.2460.
PubMed 14609782Daviglus ML, Liu K, Yan LL, Pirzada A, Garside DB, Schiffer L, Dyer AR, Greenland P, Stamler J. Body mass index in middle age and health-related quality of life in older age: the Chicago heart association detection project in industry study. Arch Intern Med. 2003 Nov 10;163(20):2448-55. doi: 10.1001/archinte.163.20.2448.
PubMed 14609781Daviglus ML, Liu K, Yan LL, Pirzada A, Manheim L, Manning W, Garside DB, Wang R, Dyer AR, Greenland P, Stamler J. Relation of body mass index in young adulthood and middle age to Medicare expenditures in older age. JAMA. 2004 Dec 8;292(22):2743-9. doi: 10.1001/jama.292.22.2743.
PubMed 15585734Yan LL, Daviglus ML, Liu K, Pirzada A, Garside DB, Schiffer L, Dyer AR, Greenland P. BMI and health-related quality of life in adults 65 years and older. Obes Res. 2004 Jan;12(1):69-76. doi: 10.1038/oby.2004.10.
PubMed 14742844Daviglus ML, Liu K, Pirzada A, Yan LL, Garside DB, Greenland P, Manheim LM, Dyer AR, Wang R, Lubitz J, Manning WG, Fries JF, Stamler J. Cardiovascular risk profile earlier in life and Medicare costs in the last year of life. Arch Intern Med. 2005 May 9;165(9):1028-34. doi: 10.1001/archinte.165.9.1028.
PubMed 15883242Liu K, Dyer AR, Vu TH, Pirzada A, Manheim LM, Manning WG, Ashraf MS, Garside DB, Daviglus ML. One-hour postload plasma glucose in middle age and Medicare expenditures in older age among nondiabetic men and women: the Chicago Heart Association Detection Project in Industry. Diabetes Care. 2005 May;28(5):1057-62. doi: 10.2337/diacare.28.5.1057.
PubMed 15855567Yan LL, Daviglus ML, Liu K, Stamler J, Wang R, Pirzada A, Garside DB, Dyer AR, Van Horn L, Liao Y, Fries JF, Greenland P. Midlife body mass index and hospitalization and mortality in older age. JAMA. 2006 Jan 11;295(2):190-8. doi: 10.1001/jama.295.2.190.
PubMed 16403931
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
- CV Risk Factors at Age 25-64 & Long-Term Medicare Costs
- ClinicalTrials.gov ID
- NCT00006296
- Acronym / sponsor ID
- 913
- 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
- Sep 2000
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 26 Sep 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 in four large Chicago population cohorts whether young adult and middle-aged risk factor status has an impact not only on average annual Medicare costs, but also on cumulative and lifetime Medicare costs, to ages 70, 75, 80, >80, including to death, and during the last one to two years of life.
Detailed description
BACKGROUND:
Studies will be conducted on the cumulative lifetime Medicare costs of individuals from four Chicago population cohorts from which prior risk factor data are available. One cohort is from the Western Electric Company Study, with 2107 men who were 40-56 when the follow up began in 1957. For this group a physical exam, ECG and cholesterol measures are available along with data from a quantitative diet history conducted at that time assessing 28 days of intake. It is not clear whether the men themselves or their wives provided this information. Repeat measures are available, but attention is paid to their use in the analyses. Also, information on the availability of the quantitative information at the food level is not provided. Two cohorts are from the Peoples Gas Company Study, one with 1594 men aged 40-59 in 1958 and the second with 1609 men aged 25-39 in 1959 . From both cohorts a total of 1802 men are, based on their ages, currently Medicare eligible.The fourth cohort is the Chicago Heart Disease Detection Association Project (CHA) based on an initial survey of 39,573 men and women conducted in 1967-1973 on whom dietary data are not available.
DESIGN NARRATIVE:
The study assesses the relationships of CVD risk factors measured in young and middle-aged adult men and women to Medicare utilization and charges, from Medicare enrollment to death or attainment of age 70, 75, 80, >80, including in the last one to two years of life. The study determines long-term relationship between earlier low-risk status vs. not-low-risk to subsequent Medicare health care charges. Baseline low risk is all six CVD risk factors favorable: systolic/diastolic pressure 120 mmHg/80 mmHg and no antihypertensive treatment, serum cholesterol <200 mg/dl, not currently smoking, no ECG abnormalities, no history of diabetes or heart attack. The study also determines the relationships between baseline habitual eating patterns and subsequent Medicare utilization and charges. Further statistical methods are developed for optimal analyses of health care expenditures. The database will be extended by obtaining additional years of morbidity-mortality experience and of Medicare charge data to the year 2002.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- 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 14609782Daviglus ML, Liu K, Pirzada A, Yan LL, Garside DB, Feinglass J, Guralnik JM, Greenland P, Stamler J. Favorable cardiovascular risk profile in middle age and health-related quality of life in older age. Arch Intern Med. 2003 Nov 10;163(20):2460-8. doi: 10.1001/archinte.163.20.2460.
- Background: PubMed 14609781Daviglus ML, Liu K, Yan LL, Pirzada A, Garside DB, Schiffer L, Dyer AR, Greenland P, Stamler J. Body mass index in middle age and health-related quality of life in older age: the Chicago heart association detection project in industry study. Arch Intern Med. 2003 Nov 10;163(20):2448-55. doi: 10.1001/archinte.163.20.2448.
- Background: PubMed 15585734Daviglus ML, Liu K, Yan LL, Pirzada A, Manheim L, Manning W, Garside DB, Wang R, Dyer AR, Greenland P, Stamler J. Relation of body mass index in young adulthood and middle age to Medicare expenditures in older age. JAMA. 2004 Dec 8;292(22):2743-9. doi: 10.1001/jama.292.22.2743.
- Background: PubMed 14742844Yan LL, Daviglus ML, Liu K, Pirzada A, Garside DB, Schiffer L, Dyer AR, Greenland P. BMI and health-related quality of life in adults 65 years and older. Obes Res. 2004 Jan;12(1):69-76. doi: 10.1038/oby.2004.10.
- Background: PubMed 15883242Daviglus ML, Liu K, Pirzada A, Yan LL, Garside DB, Greenland P, Manheim LM, Dyer AR, Wang R, Lubitz J, Manning WG, Fries JF, Stamler J. Cardiovascular risk profile earlier in life and Medicare costs in the last year of life. Arch Intern Med. 2005 May 9;165(9):1028-34. doi: 10.1001/archinte.165.9.1028.
- Background: PubMed 15855567Liu K, Dyer AR, Vu TH, Pirzada A, Manheim LM, Manning WG, Ashraf MS, Garside DB, Daviglus ML. One-hour postload plasma glucose in middle age and Medicare expenditures in older age among nondiabetic men and women: the Chicago Heart Association Detection Project in Industry. Diabetes Care. 2005 May;28(5):1057-62. doi: 10.2337/diacare.28.5.1057.
- Background: PubMed 16403931Yan LL, Daviglus ML, Liu K, Stamler J, Wang R, Pirzada A, Garside DB, Dyer AR, Van Horn L, Liao Y, Fries JF, Greenland P. Midlife body mass index and hospitalization and mortality in older age. JAMA. 2006 Jan 11;295(2):190-8. doi: 10.1001/jama.295.2.190.
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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.
Martha Daviglus
Northwestern 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 NCT00006296, which also lists 7 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.