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
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00037310
First Posted
May 16, 2002
Last Updated
July 28, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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
background
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New CVD Risk Factors for Lowered Cognitive Functioning
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