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CompletedNCT00005430Updated Feb 18, 2016

Low Cholesterol and Mortality in Blacks and Women

An observational study in Cardiovascular Diseases, Cerebrovascular Accident and Coronary Disease, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed. Open to male participants aged Up to 100 Years. Per ClinicalTrials.gov, last updated 2016-02-18.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational

Study type
Observational
Ages
Up to 100 Years
Sex
Male
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Study 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.

Read the 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 (n=2281). For the Evans County Study (n=3102), 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 cholesterol/mortality 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 cholesterol/mortality 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 disease/noncancer. 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. Urban/rural differences in the cholesterol/mortality 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.

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Conditions studied

  • Cardiovascular Diseases
  • Cerebrovascular Accident
  • Coronary Disease
  • Heart Diseases
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

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Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 100 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

No eligibility criteria

05

Study design

06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00005430
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
First posted
May 26, 2000
Start date
Sep 1993
Completion
Sep 1995
Last update
Feb 18, 2016
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2001. You cannot join it, but the record below documents what was studied.

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