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Clinical Trials/NCT00005315
NCT00005315
Completed
Not Applicable

Psychosocial Factors and Cardiovascular Disease

Columbia University0 sites893 target enrollmentSeptember 1993

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Columbia University
Enrollment
893
Primary Endpoint
24-hour ambulatory blood pressure
Status
Completed
Last Updated
last year

Overview

Brief Summary

To evaluate the role of psychosocial factors in the development of hypertension and cardiovascular disease.

To estimate the prevalence of masked hypertension and its potential role in the development of subclinical cardiovascular disease To compare the reliability of office blood pressure (BP), home BP and ambulatory BP, and their associations with subclinical cardiovascular disease

Detailed Description

DESIGN NARRATIVE: The studies had several interrelated themes. One was to explore the relationships between environmental stress and blood pressure over a range of time courses, with acute laboratory studies at one extreme, and long- term prospective studies at the other. The basic model of stress included three elements: the objective nature of the stressor, the individual's perception of it, and his or her physiological susceptibility. This model incorporated elements of the Karasek Job Strain model and the Frankenhaueser effort-distress model, with two components corresponding to demand and control. A third dimension was social support. These models were tested under both laboratory and field conditions. Blood pressure was the main dependent variable, together with structural changes in the heart and carotid arteries. Five projects were included. Project l evaluated the ability of ambulatory blood pressure, and blood pressure variability, to predict cardiovascular morbidity, and also included a cross-sectional study comparing the relationships between blood pressure and target organ damage in Black and white individuals. The hypothesis that white coat hypertension is a condition associated with lower risk than sustained hypertension was also tested. Project 2 (the Work Site Blood Pressure Study) prospectively evaluated the effects of job strain and social support on blood pressure and other outcome variables in a working population. Project 3 studied psychosocial and hormonal factors influencing diurnal variations of blood pressure in women, including the changes associated with menstruation and the menopause. Project 4 (the Masked Hypertension Study) assessed the prevalence of masked hypertension (normal BP in the clinic setting, but elevated BP in one's usual environment) and its association with subclinical cardiovascular disease (CVD); \~50% of the sample was re-evaluated an average of 6 years later. Project 5 (Improving the Detection of Hypertension) had repeat assessments of clinic BP, home BP and ambulatory BP in order to evaluate the test-retest reliability of each, and compare their associations with subclinical CVD. The study was renewed in FY 1998, FY 2003 and in FY 2009 to continue follow-up and analysis.

Registry
clinicaltrials.gov
Start Date
September 1993
End Date
August 2008
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

24-hour ambulatory blood pressure

Time Frame: baseline and follow-up (50% of sample, an average of 6.5 years later)

left ventricular mass index

Time Frame: cross-sectional (baseline) and change (an average of 6.5 years later)

by 2-D echocardiography

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