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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00037310
Other study ID # 1161
Secondary ID R01HL067358
Status Completed
Phase N/A
First received May 16, 2002
Last updated July 28, 2016
Start date April 2001
Est. completion date March 2007

Study information

Verified date January 2008
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date March 2007
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender Male
Age group N/A to 100 Years
Eligibility No eligibility criteria

Study Design

N/A


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (1)

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. Epub 2004 Oct 4. — View Citation

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