Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005315
Status:
COMPLETED
Last Update Posted:
2013-03-08
First Post:
2000-05-25
Brief Title:
Psychosocial Factors and Cardiovascular Disease
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Psychosocial Factors and Cardiovascular Disease
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 individuals 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 ones 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
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 individuals 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 ones 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5P01HL047540 | NIH | None | httpsreporternihgovquickSearch5P01HL047540 |