Cardiovascular DiseasesNCT00005492
Pooled Analysis of NHANES I/II--Race, Gender, and CHD
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To conduct a pooled analysis of NHANES I/II data on race, gender, and coronary heart disease. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 1997to Jul 2000
- 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 conduct a pooled analysis of NHANES I/II data on race, gender, and coronary heart disease.
Read the detailed description
BACKGROUND:
Over the last 25 years, a sustained and marked decline in death rates from coronary heart disease (CHD) has occurred for all major segments of the U.S. population. Recently, however, the decline has proceeded less rapidly in blacks than in whites, and in women than men. These trends have focused further attention on possible heterogeneity in the risk factor patterns among the demographic sub-groups. Previous studies of CHD risk factors in blacks and whites using the First National Health and Examination Survey Epidemiologic Follow-up Study (NHEFS-I, 11-year follow-up), including this group's own work, demonstrate its potential strengths, while at the same time foundering on the problem of low statistical power. With the extension of the follow-up of NHANES-I cohort (1971-1974) to 1987 (14 years) and the completion of 14-year follow-up for NHANES II cohort (1976-1980), a strong rationale exists to undertake a "pooling project." The resulting data set would provide optimal characterization of CHD risk at the national level.
DESIGN NARRATIVE:
The study sought to determine whether data from NHANES I and NHANES II could be pooled. To accomplish this, the distribution of baseline measures was assessed and a determination was made whether the same logistic prediction equations fitted both studies. Also, gender-race differences were examined in individual exposure-outcome relationships, patterns of co-morbidity, and population attributable risks.
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 Disease, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, 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 startAug 1997
- Study completionJul 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Youlian Liao, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005492
- Sponsor's protocol ID
- 5009
- Other IDs
- R03HL058436
- Status last verified
- Mar 2005
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Liao Y, McGee DL, Cooper RS, Sutkowski MB. How generalizable are coronary risk prediction models? Comparison of Framingham and two national cohorts. Am Heart J. 1999 May;137(5):837-45. doi: 10.1016/s0002-8703(99)70407-2.
PubMed 10220632
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
- Pooled Analysis of NHANES I/II--Race, Gender, and CHD
- ClinicalTrials.gov ID
- NCT00005492
- Acronym / sponsor ID
- 5009
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 1997
- Study completion
- Jul 2000 (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 conduct a pooled analysis of NHANES I/II data on race, gender, and coronary heart disease.
Detailed description
BACKGROUND:
Over the last 25 years, a sustained and marked decline in death rates from coronary heart disease (CHD) has occurred for all major segments of the U.S. population. Recently, however, the decline has proceeded less rapidly in blacks than in whites, and in women than men. These trends have focused further attention on possible heterogeneity in the risk factor patterns among the demographic sub-groups. Previous studies of CHD risk factors in blacks and whites using the First National Health and Examination Survey Epidemiologic Follow-up Study (NHEFS-I, 11-year follow-up), including this group's own work, demonstrate its potential strengths, while at the same time foundering on the problem of low statistical power. With the extension of the follow-up of NHANES-I cohort (1971-1974) to 1987 (14 years) and the completion of 14-year follow-up for NHANES II cohort (1976-1980), a strong rationale exists to undertake a "pooling project." The resulting data set would provide optimal characterization of CHD risk at the national level.
DESIGN NARRATIVE:
The study sought to determine whether data from NHANES I and NHANES II could be pooled. To accomplish this, the distribution of baseline measures was assessed and a determination was made whether the same logistic prediction equations fitted both studies. Also, gender-race differences were examined in individual exposure-outcome relationships, patterns of co-morbidity, and population attributable risks.
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 10220632Liao Y, McGee DL, Cooper RS, Sutkowski MB. How generalizable are coronary risk prediction models? Comparison of Framingham and two national cohorts. Am Heart J. 1999 May;137(5):837-45. doi: 10.1016/s0002-8703(99)70407-2.
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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.
Youlian Liao
Loyola University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Disease, 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 NCT00005492, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 8 Nov 2026.