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Cardiovascular DiseasesNCT00005430

Low Cholesterol and Mortality in Blacks and Women

An observational study of Cardiovascular Diseases and Cerebrovascular Accident, run by National Heart, Lung, and Blood Institute (NHLBI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages Up to 100 years, men only
How many people
Not given
Where
No sites listed yet
Study dates
Sep 1993to Sep 1995
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 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.

Medical subject headings
Cardiovascular Diseases, Stroke, 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.

  1. First posted26 May 2000 (estimated)
  2. Study startSep 1993
  3. Study completionSep 1995

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005430
Sponsor's protocol ID
4348
Other IDs
R03HL051385
Status last verified
Nov 2001
First submitted
25 May 2000
Last updated
18 Feb 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Cerebrovascular Accident, 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?
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.

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