End Stage Renal Disease Clinical Trial
Official title:
Prospective Study of Inflammatory Markers and Genes as Predictors of Atherosclerotic Cardiovascular Disease in Dialysis Patients
Verified date | March 1, 2012 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study, done in collaboration with Johns Hopkins University School of Public Health in
Baltimore, Maryland, will examine the role of genes in the development of atherosclerotic
cardiovascular disease (CVD) in patients undergoing kidney dialysis. The rate of illness and
death from CVD among patients on dialysis is extraordinarily high, accounting for about 50
percent of deaths. Blood levels of inflammatory markers are elevated in these patients,
strongly predicting illness and death from CVD. The discovery of gene variants related to the
inflammatory process in atherosclerotic CVD may lead to better medical treatments and
improved survival in patients with end-stage kidney disease.
Participants of John's Hopkins University's CHOICE (Choices for Healthy Outcomes in Caring
for End-Stage Renal Disease) program are included in this study. Blood samples previously
collected from these patients will be analyzed in the laboratory for genes that might be
associated with the inflammatory process and atherogenesis.
Status | Completed |
Enrollment | 871 |
Est. completion date | March 1, 2012 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
- INCLUSION CRITERIA: Original eligibility criteria for enrollment in the CHOICE cohort included: 1) new onset of chronic outpatient renal replacement therapy in the last 3 months, 2) ability to give informed consent to participate in the study, 3) age 19 years or older, 4) ability to speak English or Spanish. EXCLUSION CRITERIA: The entire set of 871 samples available to the LGD will be analyzed. No subject will be excluded. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Georges JL, Loukaci V, Poirier O, Evans A, Luc G, Arveiler D, Ruidavets JB, Cambien F, Tiret L. Interleukin-6 gene polymorphisms and susceptibility to myocardial infarction: the ECTIM study. Etude Cas-Témoin de l'Infarctus du Myocarde. J Mol Med (Berl). 2001 Jun;79(5-6):300-5. — View Citation
Longenecker JC, Coresh J, Klag MJ, Levey AS, Martin AA, Fink NE, Powe NR. Validation of comorbid conditions on the end-stage renal disease medical evidence report: the CHOICE study. Choices for Healthy Outcomes in Caring for ESRD. J Am Soc Nephrol. 2000 Mar;11(3):520-9. — View Citation
Longenecker JC, Coresh J, Powe NR, Levey AS, Fink NE, Martin A, Klag MJ. Traditional cardiovascular disease risk factors in dialysis patients compared with the general population: the CHOICE Study. J Am Soc Nephrol. 2002 Jul;13(7):1918-27. — View Citation
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