Cardiac and Renal Disease Study (CARDS)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00049907
First received: November 14, 2002
Last updated: January 27, 2006
Last verified: January 2006
  Purpose

To examine the epidemiology of renal disease and its relationship to cardiovascular disease.


Condition
Coronary Disease
Cardiovascular Diseases
Cerebrovascular Accident
Heart Failure
Heart Diseases
Peripheral Vascular Diseases
Diabetes Mellitus
Hypertension
Kidney Failure, Chronic

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 2002
Estimated Study Completion Date: August 2004
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 relationships,including 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 (race/ethnicity, 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049907

Sponsors and Collaborators
Investigators
Investigator: Carlos Iribarren Kaiser Foundation Research Institute
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00049907     History of Changes
Other Study ID Numbers: 1200
Study First Received: November 14, 2002
Last Updated: January 27, 2006
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hypertension
Diabetes Mellitus
Heart Failure
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Coronary Disease
Coronary Artery Disease
Renal Insufficiency
Cerebral Infarction
Stroke
Peripheral Vascular Diseases
Peripheral Arterial Disease
Kidney Failure, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Kidney Diseases
Urologic Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Atherosclerosis
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on October 19, 2014