Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049907
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2002-11-14
Brief Title:
Cardiac and Renal Disease Study CARDS
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-01
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:
To examine the epidemiology of renal disease and its relationship to cardiovascular disease
Detailed Description:
BACKGROUND
Mild-to-moderate chronic renal insufficiency CRI has been reaching epidemic proportions in the United States Studies relating mild-to-moderate chronic renal insufficiency and cardiovascular risk were limited and inconsistent Although much had been learned about the natural history and adverse outcomes associated with end-stage renal disease ESRD there was little specific information regarding risk factors for the development or progression of renal disease
The study was initiated in response to a Request for Applications entitled NHLBI Innovative Research Grant Program released in July 2001 The purpose of the initiative was to support new approaches to heart lung and blood diseases and sleep disorders that used existing data sets or existing biological specimen collections whether obtained through National Heart Lung and Blood Institute support or not
DESIGN NARRATIVE
The population-based study used data on an ethnically diverse large cohort of male and female health plan enrollees with extended follow-up The study evaluated a whether baseline and decline in renal function over time were independent predictors of coronary heart disease CHD stroke heart failure and peripheral vascular disease b effect modifiers of these relationshipsincluding baseline hypertension and diabetes status The study determined whether baseline and increase over time in blood pressure level as well as prevalent and incident hypertension were predictive of the subsequent risk of ESRD after adjusting for diabetes and for baseline serum creatinine proteinuria and hematuria The study also examined other potential predictors of ESRD including demographic factors raceethnicity level of education total cholesterol level family history of renal disease body mass index sagittal abdominal diameter cigarette as well as cigar and pipe smoking coffee intake alcohol consumption family history of renal disease and self-reported occupational exposures The study used existing longitudinal data resources at the Northern California Kaiser Permanente Division of Research and available patient-level cross-linkage with the US Renal Data System end-stage renal disease registry to obtain comprehensive renal and cardiovascular outcomes
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Mild-to-moderate chronic renal insufficiency CRI has been reaching epidemic proportions in the United States Studies relating mild-to-moderate chronic renal insufficiency and cardiovascular risk were limited and inconsistent Although much had been learned about the natural history and adverse outcomes associated with end-stage renal disease ESRD there was little specific information regarding risk factors for the development or progression of renal disease
The study was initiated in response to a Request for Applications entitled NHLBI Innovative Research Grant Program released in July 2001 The purpose of the initiative was to support new approaches to heart lung and blood diseases and sleep disorders that used existing data sets or existing biological specimen collections whether obtained through National Heart Lung and Blood Institute support or not
DESIGN NARRATIVE
The population-based study used data on an ethnically diverse large cohort of male and female health plan enrollees with extended follow-up The study evaluated a whether baseline and decline in renal function over time were independent predictors of coronary heart disease CHD stroke heart failure and peripheral vascular disease b effect modifiers of these relationshipsincluding baseline hypertension and diabetes status The study determined whether baseline and increase over time in blood pressure level as well as prevalent and incident hypertension were predictive of the subsequent risk of ESRD after adjusting for diabetes and for baseline serum creatinine proteinuria and hematuria The study also examined other potential predictors of ESRD including demographic factors raceethnicity level of education total cholesterol level family history of renal disease body mass index sagittal abdominal diameter cigarette as well as cigar and pipe smoking coffee intake alcohol consumption family history of renal disease and self-reported occupational exposures The study used existing longitudinal data resources at the Northern California Kaiser Permanente Division of Research and available patient-level cross-linkage with the US Renal Data System end-stage renal disease registry to obtain comprehensive renal and cardiovascular outcomes
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL071074 | NIH | None | httpsreporternihgovquickSearchR01HL071074 |