Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005430
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Low Cholesterol and Mortality in Blacks and Women
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-11
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 determine and compare the long term thirty year relationship of total cholesterol and mortality in Blacks and whites in a predominantly urban Charleston South Carolina cohort and a predominantly rural Evans County Georgia cohort with special emphasis on the investigation of the association of low cholesterol to all cause cardiovascular disease CVD and non-CVD mortality
Detailed Description:
BACKGROUND
The Charleston Heart Study and the Evans County Study were both begun in 1960 as prospective cohort studies designed to study risk factors of cardiovascular disease in biracial communities The Charleston Heart Study cohort comprised a random sample of Black and white men and women residents of Charleston County South Carolina who were 35 years of age or older in 1960 n2281 For the Evans County Study n3102 100 percent of the population of Evans County Georgia who were 40 years and older and 50 percent of the residents 15-39 years of age were recruited 92 percent response rate
Because of the paucity of data on Blacks and women the data from the combined Charleston and Evans County studies provided important information on the existence of a low cholesterolmortality association and potential effect modifiers in these understudied populations
DESIGN NARRATIVE
Using datasets the study 1 determined if a J-shaped or U-shaped relationship between cholesterol and all-cause and non-CVD mortality was observed in the Charleston and Evans County Georgia cohorts of Blacks and whites 2 investigated the existence of racial gender and place of residence urban versus rural differences in the relationship of cholesterol to mortality with particular emphasis on identification of racial and gender differences in the low cholesterolmortality association 3 determined if socioeconomic status SES modified the effect of cholesterol on mortality in Black and white women and Black and white men and determined if the effect modification of SES if found to exist was different in urban and rural settings Data were analyzed both separately for each cohort for comparison across cohorts and were pooled for combined analyses Cox proportional hazards regression analyses were used to model the relationship of total cholesterol to the following mortality endpoints all cause cardiovascular disease coronary heart disease stroke cancer non-cardiovascular diseasenoncancer Racial and gender differences in the relationship of cholesterol to mortality were investigated through both race-sex stratified analyses and inclusion of interaction terms for these variables in the regression model Urbanrural differences in the cholesterolmortality association were evaluated by testing for significance of difference in the regression coefficients for the cholesterol term in the regression models run separately for both study cohorts The effect modification of the cholesterol mortality association by SES was investigated by comparison of the regression coefficients for cholesterol in models analyzed separately by high and low SES strata and in models containing an SES by cholesterol interaction term
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
The Charleston Heart Study and the Evans County Study were both begun in 1960 as prospective cohort studies designed to study risk factors of cardiovascular disease in biracial communities The Charleston Heart Study cohort comprised a random sample of Black and white men and women residents of Charleston County South Carolina who were 35 years of age or older in 1960 n2281 For the Evans County Study n3102 100 percent of the population of Evans County Georgia who were 40 years and older and 50 percent of the residents 15-39 years of age were recruited 92 percent response rate
Because of the paucity of data on Blacks and women the data from the combined Charleston and Evans County studies provided important information on the existence of a low cholesterolmortality association and potential effect modifiers in these understudied populations
DESIGN NARRATIVE
Using datasets the study 1 determined if a J-shaped or U-shaped relationship between cholesterol and all-cause and non-CVD mortality was observed in the Charleston and Evans County Georgia cohorts of Blacks and whites 2 investigated the existence of racial gender and place of residence urban versus rural differences in the relationship of cholesterol to mortality with particular emphasis on identification of racial and gender differences in the low cholesterolmortality association 3 determined if socioeconomic status SES modified the effect of cholesterol on mortality in Black and white women and Black and white men and determined if the effect modification of SES if found to exist was different in urban and rural settings Data were analyzed both separately for each cohort for comparison across cohorts and were pooled for combined analyses Cox proportional hazards regression analyses were used to model the relationship of total cholesterol to the following mortality endpoints all cause cardiovascular disease coronary heart disease stroke cancer non-cardiovascular diseasenoncancer Racial and gender differences in the relationship of cholesterol to mortality were investigated through both race-sex stratified analyses and inclusion of interaction terms for these variables in the regression model Urbanrural differences in the cholesterolmortality association were evaluated by testing for significance of difference in the regression coefficients for the cholesterol term in the regression models run separately for both study cohorts The effect modification of the cholesterol mortality association by SES was investigated by comparison of the regression coefficients for cholesterol in models analyzed separately by high and low SES strata and in models containing an SES by cholesterol interaction term
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 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 |
|---|---|---|---|
| R03HL051385 | NIH | None | httpsreporternihgovquickSearchR03HL051385 |