Cardiovascular DiseasesNCT00005463
Population-Based Modeling of Cholesterol Lowering in the United States
An observational study of Cardiovascular Diseases and Coronary Heart Disease Risk Reduction, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To evaluate the cost-effectiveness of cholesterol-lowering strategies in the United States population. The study used the Coronary Heart Disease (CHD) Policy Model, a state-transition computer simulation model used to obtain forecasts of the public health impact and economic cost of CHD in the United States population. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Heart Disease Risk Reduction, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 1991to May 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 evaluate the cost-effectiveness of cholesterol-lowering strategies in the United States population. The study used the Coronary Heart Disease (CHD) Policy Model, a state-transition computer simulation model used to obtain forecasts of the public health impact and economic cost of CHD in the United States population.
Read the detailed description
BACKGROUND:
The study was part of an Institute-initiated Request for Applications (RFA) titled "Cost-Effective Strategies of Cholesterol-Lowering" released by the NHLBI in 1990. The RFA was stimulated by the controversy concerning costs and cost-effectiveness that followed the 1987 report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. The RFA was intended to support a broad and thorough quantitative exploration of the potential health benefits and costs of cholesterol-lowering from multiple perspectives.
DESIGN NARRATIVE:
The study added to the CHD Policy Model the capability to model the consequences of reductions in LDL cholesterol and increases in HDL/LDL ratios in the United States population. The CHD Policy Model was used for several studies, including: to compare the implications of using alternative epidemiologic studies as the basis for estimating the association between cholesterol levels and CHD risk; to derive cutting points for initiating cholesterol reduction, specific to age, sex, and CHD risk factors, and based on cost-effectiveness criteria; to compare the cost-effectiveness of specific targeted and population-wide strategies for cholesterol reduction; to incorporate the effects of treatments on quality of life, including both adverse effects of cholesterol-lowering drugs and reductions in CHD morbid events; and finally, to perform a cost-effectiveness analysis of cholesterol screening, incorporating costs of screening, effects of measurement error on misclassification of patients, and variations in individual cholesterol levels over time.
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 Heart Disease Risk Reduction, Heart Diseases, Coronary Disease, Hypercholesterolemia
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Hypercholesterolemia
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 1991
- Study completionMay 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- NCT00005463
- Sponsor's protocol ID
- 4907
- Other IDs
- R01HL046315
- Status last verified
- Sep 2002
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Goldman L, Goldman PA, Williams LW, Weinstein MC. Cost-effectiveness considerations in the treatment of heterozygous familial hypercholesterolemia with medications. Am J Cardiol. 1993 Sep 30;72(10):75D-79D. doi: 10.1016/0002-9149(93)90015-5.
PubMed 8213502Hunink MG, Goldman L, Tosteson AN, Mittleman MA, Goldman PA, Williams LW, Tsevat J, Weinstein MC. The recent decline in mortality from coronary heart disease, 1980-1990. The effect of secular trends in risk factors and treatment. JAMA. 1997 Feb 19;277(7):535-42.
PubMed 9032159Tosteson AN, Weinstein MC, Hunink MG, Mittleman MA, Williams LW, Goldman PA, Goldman L. Cost-effectiveness of populationwide educational approaches to reduce serum cholesterol levels. Circulation. 1997 Jan 7;95(1):24-30. doi: 10.1161/01.cir.95.1.24.
PubMed 8994412
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
- Population-Based Modeling of Cholesterol Lowering in the United States
- ClinicalTrials.gov ID
- NCT00005463
- Acronym / sponsor ID
- 4907
- Conditions
- Cardiovascular Diseases, Coronary Heart Disease Risk Reduction, Heart Diseases, Coronary Disease, Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 1991
- Study completion
- May 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 evaluate the cost-effectiveness of cholesterol-lowering strategies in the United States population. The study used the Coronary Heart Disease (CHD) Policy Model, a state-transition computer simulation model used to obtain forecasts of the public health impact and economic cost of CHD in the United States population.
Detailed description
BACKGROUND:
The study was part of an Institute-initiated Request for Applications (RFA) titled "Cost-Effective Strategies of Cholesterol-Lowering" released by the NHLBI in 1990. The RFA was stimulated by the controversy concerning costs and cost-effectiveness that followed the 1987 report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. The RFA was intended to support a broad and thorough quantitative exploration of the potential health benefits and costs of cholesterol-lowering from multiple perspectives.
DESIGN NARRATIVE:
The study added to the CHD Policy Model the capability to model the consequences of reductions in LDL cholesterol and increases in HDL/LDL ratios in the United States population. The CHD Policy Model was used for several studies, including: to compare the implications of using alternative epidemiologic studies as the basis for estimating the association between cholesterol levels and CHD risk; to derive cutting points for initiating cholesterol reduction, specific to age, sex, and CHD risk factors, and based on cost-effectiveness criteria; to compare the cost-effectiveness of specific targeted and population-wide strategies for cholesterol reduction; to incorporate the effects of treatments on quality of life, including both adverse effects of cholesterol-lowering drugs and reductions in CHD morbid events; and finally, to perform a cost-effectiveness analysis of cholesterol screening, incorporating costs of screening, effects of measurement error on misclassification of patients, and variations in individual cholesterol levels over time.
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 8213502Goldman L, Goldman PA, Williams LW, Weinstein MC. Cost-effectiveness considerations in the treatment of heterozygous familial hypercholesterolemia with medications. Am J Cardiol. 1993 Sep 30;72(10):75D-79D. doi: 10.1016/0002-9149(93)90015-5.
- Background: PubMed 9032159Hunink MG, Goldman L, Tosteson AN, Mittleman MA, Goldman PA, Williams LW, Tsevat J, Weinstein MC. The recent decline in mortality from coronary heart disease, 1980-1990. The effect of secular trends in risk factors and treatment. JAMA. 1997 Feb 19;277(7):535-42.
- Background: PubMed 8994412Tosteson AN, Weinstein MC, Hunink MG, Mittleman MA, Williams LW, Goldman PA, Goldman L. Cost-effectiveness of populationwide educational approaches to reduce serum cholesterol levels. Circulation. 1997 Jan 7;95(1):24-30. doi: 10.1161/01.cir.95.1.24.
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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 Heart Disease Risk Reduction, 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 NCT00005463, which also lists 3 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.