This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a multicenter observational study to gain understanding of the relationship between progressive renal disease and cardiovascular illness. The principal goals of the study are to examine risk factors for chronic renal insufficiency (CRI) and cardiovascular disease (CVD) events among patients with varying severity of CRI, and to develop predictive models that will identify high-risk subgroups with CRI. The latter results will target enrollment of high-risk subjects into future treatment trials and increase application of available preventive therapies. Improved recognition of etiological factors will permit development and testing of interventions to reduce the burden of advanced renal failure and cardiovascular morbidity and mortality. The study will address the following hypotheses: 1) A set of non-traditional risk factors is associated with both progression of CRI and development of end stage renal disease, 2) A set of non-traditional risk factors is associated with CVD events and measures of CVD progression in the setting of CRI, 3) The risk factors for CRI progression and CVD in the setting of CRI vary by demographic characteristics (age/gender, race/ethnicity) and diabetes status, 4) The morbidity and complications associated with CRI and its progression diminish global and disease-specific quality of life, impair functional status, and increase health resource utilization, and 5) Progression of CRI as estimated by serum creatinine, 1/serum creatinine, and currently available serum creatinine-based formulae may yield biased estimates of the rate of progression of CRI. The CRIC study population will include a racially and ethnically diverse group of adult patients (age 21-74) with mild-to-moderate chronic renal insufficiency (it is estimated that half of the subjects will have diagnosed diabetes mellitus). 3000 participants will be enrolled nationally at 7 centers, 450-500 subjects at this site. Cohort members will be followed throughout the entire duration of clinical follow-up (6 years) or until death. The study consists of screening and baseline visits, annual clinic visits, and telephone interviews in between clinic visits. Extensive data will be collected including: 1) sociodemographic, comorbidity, treatment, anthropometric, psychosocial, quality of life and health care resource utilization measures, 2) renal function measures, 3) cardiovascular measures, and 4) biochemical measures. Approximately one third of the subjects (randomly selected) will have glomerular filtration rate (GFR) testing at the baseline, 2-year and 4-year visits. This study will require 7 outpatient visits at the GCRC per subjec

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000080-44
Application #
7378049
Study Section
Special Emphasis Panel (ZRR1-CR-1 (01))
Project Start
2006-04-01
Project End
2007-03-31
Budget Start
2006-04-01
Budget End
2007-03-31
Support Year
44
Fiscal Year
2006
Total Cost
$75,318
Indirect Cost
Name
Case Western Reserve University
Department
Type
Schools of Medicine
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
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