Trial Information

Prospective Study of Inflammatory Markers and Genes as Predictors of Atherosclerotic Cardiovascular Disease in Dialysis Patients

Background:

The CHOICE (Choices for Healthy Outcomes in Caring for End stage renal disease) study is a
national prospective cohort study of 1,041 incident dialysis patients aged 19 to 95
recruited in 81 dialysis clinics between October 1995 and June 1998, and is overseen by the
Johns Hopkins University School of Public Health.

The discovery of genetic associations offers the potential to direct clinical management in
order to prevent ASCVD (Atherosclerotic Cardiovascular Disease) and improve survival in
patients with end stage renal disease (ESRD).

Objectives:

In Collaboration with investigators of the CHOICE cohort, we propose to assess the role of
variants in genes related to the inflammatory process on atherosclerotic cardiovascular
disease (ASCVD) incidence.

Eligibility:

Eligibility is independent of age, race, ethnicity, and gender. However, no participants in
this cohort are less than 19 years of age.

Design:

Frozen buffy coats from 871 patients will be sent to the LGD, and DNA will be extracted.

Singles nucleotide polymorphisms (SNPs) within coding regions, upstream or downstream
regulatory regions or in intronic regions of candidates genes will be genotyped.

The first candidate genes under study include IL6, IL10, TGFB1, Beta Fibrinogen, LTA, and
STAT3.

Blood samples and relevant clinical data will be provided by Johns Hopkins University School
of Public Health, Department of Epidemiology with only numerical code which links samples
and clinical data. While Johns Hopkins University will retain patient identifier
information, the LGD will have no way of identifying the person from whom the blood,
subsequent DNA, and clinical data are obtained.

The samples are maintained in our repository and curated through our central Laboratory
database.

Destruction or loss of clinical samples or data will be recorded in our database and cannot
impact the study participants in any way.

At the completion of this protocol, we will retain the samples for future use. We understand
that studies subsequent to the completion of this protocol will require additional OHSR/IRB
approval prior to commencement.