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New CVD Risk Factors for Lowered Cognitive Functioning

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Hypertension

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 Cardiovascular Diseases

Eligibility Criteria

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

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 16, 2002
    Last Updated
    July 28, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00037310
    Brief Title
    New CVD Risk Factors for Lowered Cognitive Functioning
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2001 (undefined)
    Primary Completion Date
    March 2007 (Actual)
    Study Completion Date
    March 2007 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    To explore the associations between cognitive functioning and three major cardiovascular disease risk factors: high blood pressure; high total plasma homocysteine (tHcy); and ApoE e4 genotype.
    Detailed Description
    BACKGROUND: Arterial hypertension and high blood pressure (HBP) are major risk factors for cardiovascular disease (CVD) and stroke; they are also risk factors for lowered cognitive functioning. Except for diabetes, there have been comparatively few studies of other common risk factors, particularly with regard to interrelationships among risk factors which may adversely affect cognitive ability. DESIGN NARRATIVE: The study examines associations between cognitive functioning and three cardiovascular risk factors: 1) high blood pressure; 2) high total plasma homocysteine (tHcy), and 3) ApoE e4 genotype. These associations are examined cross-sectionally as well as longitudinally, using data collected at a follow-up visit of members of a cohort that has been followed for the past 18-19 years. Longitudinal data are used to examine both current and change in cognitive functioning. Some analyses are prospective (e.g., high blood pressure and change in cognitive functioning), while others are cross-sectional (e.g., ApoE e4 and current cognitive functioning) or retrospective (e.g., tHcy and change in cognitive functioning). Structural equation models are used to examine cross-sectional data in elucidating a general theoretical model. Two-stage growth curve analyses and survival analyses are appropriate methods for analyzing the longitudinal data. The study includes a very comprehensive set of measures that have already been collected or will be collected during the follow-up visit. All potential confounders of the association between the three target predictor variables and the various domains of cognitive functioning appear to have been included in this design.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Hypertension, Neurologic Manifestations

    7. Study Design

    10. Eligibility

    Sex
    Male
    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
    Merrill Elias
    Organizational Affiliation
    University of Maine

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15466661
    Citation
    Elias PK, Elias MF, Robbins MA, Budge MM. Blood pressure-related cognitive decline: does age make a difference? Hypertension. 2004 Nov;44(5):631-6. doi: 10.1161/01.HYP.0000145858.07252.99. Epub 2004 Oct 4.
    Results Reference
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