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Cardiac and Renal Disease Study (CARDS)

Primary Purpose

Coronary Disease, Cardiovascular Diseases, Cerebrovascular Accident

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Coronary Disease

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 14, 2002
    Last Updated
    February 17, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00049907
    Brief Title
    Cardiac and Renal Disease Study (CARDS)
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    January 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    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 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. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Disease, Cardiovascular Diseases, Cerebrovascular Accident, Heart Failure, Heart Diseases, Peripheral Vascular Diseases, Diabetes Mellitus, Hypertension, Kidney Failure, Chronic

    7. Study Design

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carlos Iribarren
    Organizational Affiliation
    Kaiser Foundation Research Institute

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15851645
    Citation
    Hsu CY, McCulloch CE, Darbinian J, Go AS, Iribarren C. Elevated blood pressure and risk of end-stage renal disease in subjects without baseline kidney disease. Arch Intern Med. 2005 Apr 25;165(8):923-8. doi: 10.1001/archinte.165.8.923.
    Results Reference
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    PubMed Identifier
    16389251
    Citation
    Hsu CY, McCulloch CE, Iribarren C, Darbinian J, Go AS. Body mass index and risk for end-stage renal disease. Ann Intern Med. 2006 Jan 3;144(1):21-8. doi: 10.7326/0003-4819-144-1-200601030-00006.
    Results Reference
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    Cardiac and Renal Disease Study (CARDS)

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