Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340119
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Genetic Susceptibility to Cardiovascular Disease in Patients on Kidney Dialysis
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Prospective Study of Inflammatory Markers and Genes as Predictors of Atherosclerotic Cardiovascular Disease in Dialysis Patients
Status:
COMPLETED
Status Verified Date:
2012-03-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Johns Hopkins Universitys 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
Participants of Johns Hopkins Universitys 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
Detailed Description:
Background
The CHOICE Choices for Healthy Outcomes in Caring for End stage renal disease study is a national prospective cohort study of 1041 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 OHSRIRB approval prior to commencement
The CHOICE Choices for Healthy Outcomes in Caring for End stage renal disease study is a national prospective cohort study of 1041 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 OHSRIRB approval prior to commencement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-C-N125 | None | None | None |