Psychosocial Factors and Cardiovascular Disease

July 17, 2024 updated by: Columbia University

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

893

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants were recruited from 4 worksites and seen at one of two study sites.

Description

Employed screening blood pressure <=160/105 mmHg not taking antihypertensive medication no evidence of secondary hypertension no history of cardiovascular disease (myocardial infarction, stroke, heart failure, peripheral vascular disease).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour ambulatory blood pressure
Time Frame: baseline and follow-up (50% of sample, an average of 6.5 years later)
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
cross-sectional (baseline) and change (an average of 6.5 years later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Joseph Schwartz, PhD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1993

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (Estimated)

May 26, 2000

Study Record Updates

Last Update Posted (Actual)

July 18, 2024

Last Update Submitted That Met QC Criteria

July 17, 2024

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4078
  • 5P01HL047540 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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