Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064480
Status:
COMPLETED
Last Update Posted:
2018-05-15
First Post:
2003-07-08
Brief Title:
Black Pooling Project
Sponsor:
Medical University of South Carolina
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To conduct a person-level meta-analysis by pooling 9 United States studies with both black and white cohorts
Detailed 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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL072377 | NIH | None | httpsreporternihgovquickSearchR01HL072377 |