Psychosocial Factors and Cardiovascular Disease

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00005315
First received: May 25, 2000
Last updated: March 7, 2013
Last verified: August 2008
  Purpose

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


Condition
Cardiovascular Diseases
Heart Diseases
Hypertension

Study Type: Observational
Official Title: Psychosocial Factors and Cardiovascular Disease

Resource links provided by NLM:


Further study details as provided by Columbia University:

Study Start Date: September 1993
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
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 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 assessed within-subject changes of blood pressure in subjects exposed to changing levels of occupational stress over two months. Project 5 examined the conceptual models of job strain, social support, and white coat hypertension in controlled laboratory conditions.

The study was renewed in FY 1998 and in FY 2003 to continue follow-up and analysis.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005315

Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Joseph Schwartz, PhD Columbia University
  More Information

Publications:

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00005315     History of Changes
Other Study ID Numbers: 4078, 5P01HL047540
Study First Received: May 25, 2000
Last Updated: March 7, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Hypertension
Vascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014