Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00064480 |
| Other study ID # |
1222 |
| Secondary ID |
R01HL072377 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 2003 |
| Est. completion date |
December 2007 |
Study information
| Verified date |
April 2008 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
To conduct a person-level meta-analysis by pooling 9 United States studies with both black
and white cohorts.
Description:
BACKGROUND:
Over the last three decades a sustained and marked decline in death rates from coronary heart
disease (CHD) has occurred for all major demographic groups of the US 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. As is well recognized, the knowledge on CHD risk
factors and statistical models used to predict personal risk of CHD have been based on
studies among white populations. In some epidemiological studies with samples from black
populations, large variation in the effect of specific factors has been noted. Given the
small sample of blacks under investigation, however, low statistical power exists for many of
the black-white comparisons. The fundamental obstacle to progress in this area remains the
absence of the cohorts of sufficient size that is representative of all four major groups.
Hence, a strong rationale exists to undertake a "pooling project" to clarify a set of
important unanswered questions in cardiovascular disease epidemiology.
DESIGN NARRATIVE:
Person-level meta-analysis will be conducted by pooling 9 large United States epidemiologic
studies with both black and white samples: the First National Health and Nutrition
Examination Survey (NHANES I) Epidemiological Follow-up Study, the NHANES II Mortality
Follow-up Study, the Charleston Heart Study, the Evans County Heart Study, the Chicago Heart
Association Detection Project in Industry, the Atherosclerosis Risk in Communities Study
(ARIC), the Follow-up Study of the screenees for the Multiple Risk Factors Intervention Trial
(MRFIT), the Follow-up Study of the participants from the MRFIT, and the Follow-up Study of
the participants from the Hypertension Detection and Follow-up Program (HDFP). Black-white
comparison will be performed on the CHD incidence and mortality, exposure-outcome
relationship, patterns of co-morbidity (or coexistence of risk factors) and population
attributable risk. Multivariate risk functions will also be examined in blacks and whites in
the three contexts: ordering risk, magnitude of relative risks, and estimation of absolute
risk.
