Cardiovascular DiseasesNCT00005495
Primary Prevention of CHD Risk Factors Occurring in US
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To evaluate the effectiveness of primary prevention of coronary heart disease risk factors by examining data from the National Health Examination Survey (NHES) and the National Health and Nutrition Examination Surveys (NHANES) to determine whether more recent birth cohorts were attaining lower blood pressure and… 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 Heart Disease Risk Reduction
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1998to Jun 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 evaluate the effectiveness of primary prevention of coronary heart disease risk factors by examining data from the National Health Examination Survey (NHES) and the National Health and Nutrition Examination Surveys (NHANES) to determine whether more recent birth cohorts were attaining lower blood pressure and cholesterol levels than earlier birth cohorts.
Read the detailed description
BACKGROUND:
The coronary heart disease risk factor profile of Americans has been improving, with decreasing blood pressure and cholesterol levels. However, it is not apparent whether this improvement is due to primary prevention of risk factors through lifestyle choices or to secondary prevention (management) of established risk factors. Since secondary prevention only targets people with high blood pressure or cholesterol levels, the effect should be demonstrated by temporal declines in the upper percentiles (75th, 90th) of the blood pressure and cholesterol distributions. Primary prevention should shift the entire risk factor distribution, including the percentiles in the middle (50th) and lower (10th, 25th) portions of the distribution. Thus, the effectiveness of primary prevention programs can be evaluated by examining temporal changes in the middle and lower percentiles, and the effectiveness of secondary prevention can be evaluated by examining temporal changes in the higher percentiles.
DESIGN NARRATIVE:
Data from the National Health Examination Survey and the National Health and Nutrition Examination Surveys were examined to determine whether more recent birth cohorts were attaining lower blood pressure and cholesterol levels than earlier birth cohorts. The results of these analyses provided information that may help guide further research and application of population prevention strategies.
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 Heart Disease Risk Reduction, Coronary Disease, Hypertension, Hypercholesterolemia
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Hypertension, 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 startJul 1998
- Study completionJun 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- David Goff, Jr., Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005495
- Sponsor's protocol ID
- 5013
- Other IDs
- R03HL058697
- Status last verified
- Nov 2002
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Goff DC Jr, Labarthe DR, Howard G, Russell GB. Primary prevention of high blood cholesterol concentrations in the United States. Arch Intern Med. 2002 Apr 22;162(8):913-9. doi: 10.1001/archinte.162.8.913.
PubMed 11966343Goff DC, Howard G, Russell GB, Labarthe DR. Birth cohort evidence of population influences on blood pressure in the United States, 1887-1994. Ann Epidemiol. 2001 May;11(4):271-9. doi: 10.1016/s1047-2797(00)00224-6.
PubMed 11306346
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
- Primary Prevention of CHD Risk Factors Occurring in US
- ClinicalTrials.gov ID
- NCT00005495
- Acronym / sponsor ID
- 5013
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Heart Disease Risk Reduction, Coronary Disease, Hypertension, Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1998
- Study completion
- Jun 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 evaluate the effectiveness of primary prevention of coronary heart disease risk factors by examining data from the National Health Examination Survey (NHES) and the National Health and Nutrition Examination Surveys (NHANES) to determine whether more recent birth cohorts were attaining lower blood pressure and cholesterol levels than earlier birth cohorts.
Detailed description
BACKGROUND:
The coronary heart disease risk factor profile of Americans has been improving, with decreasing blood pressure and cholesterol levels. However, it is not apparent whether this improvement is due to primary prevention of risk factors through lifestyle choices or to secondary prevention (management) of established risk factors. Since secondary prevention only targets people with high blood pressure or cholesterol levels, the effect should be demonstrated by temporal declines in the upper percentiles (75th, 90th) of the blood pressure and cholesterol distributions. Primary prevention should shift the entire risk factor distribution, including the percentiles in the middle (50th) and lower (10th, 25th) portions of the distribution. Thus, the effectiveness of primary prevention programs can be evaluated by examining temporal changes in the middle and lower percentiles, and the effectiveness of secondary prevention can be evaluated by examining temporal changes in the higher percentiles.
DESIGN NARRATIVE:
Data from the National Health Examination Survey and the National Health and Nutrition Examination Surveys were examined to determine whether more recent birth cohorts were attaining lower blood pressure and cholesterol levels than earlier birth cohorts. The results of these analyses provided information that may help guide further research and application of population prevention strategies.
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 11966343Goff DC Jr, Labarthe DR, Howard G, Russell GB. Primary prevention of high blood cholesterol concentrations in the United States. Arch Intern Med. 2002 Apr 22;162(8):913-9. doi: 10.1001/archinte.162.8.913.
- Background: PubMed 11306346Goff DC, Howard G, Russell GB, Labarthe DR. Birth cohort evidence of population influences on blood pressure in the United States, 1887-1994. Ann Epidemiol. 2001 May;11(4):271-9. doi: 10.1016/s1047-2797(00)00224-6.
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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.
David Goff, Jr.
Wake Forest 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 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 NCT00005495, which also lists 2 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.