Ignite Creation Date:
2025-12-18 @ 8:55 AM
Ignite Modification Date:
2025-12-23 @ 11:15 PM
Study NCT ID:
NCT00005476
Status:
None
Last Update Posted:
2016-07-29 00:00:00
First Post:
2000-05-25 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sociodemographic Regulation of Cardiovascular Function and Structure
Sponsor:
None
Organization:
Study Overview
Official Title:
None
Status:
None
Status Verified Date:
2009-05
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:
BACKGROUND:
Given increasing awareness of the extent to which environments typically faced by ethnic groups differ, environmental influence on these processes may be an important factor that is an aspect of ethnicity. Socioeconomic status (SES) is a useful index of such environments and is associated with cardiovascular disease (CVD). Since behavior is one pathway through which SES influences are thought to be expressed in disease, this study focuses specifically on stress responsivity, which is thought to be linked to the pathophysiology of CVD. Since such disease has its antecedents in childhood, a multiethnic pediatric sample is employed. In addition, the subject sample consists of twins. Investigation of the impact of environments on the expression of CVD can be achieved only with proper control for biological influences.
DESIGN NARRATIVE:
Subjects completed three laboratory stressors: a video game task, a structured social interview, and the cold pressor. Stress responsivity was assessed, with particular interest being paid to systemic vascular resistance (SVR). Left ventricular mass (LVM) was also assessed. Sophisticated environmentally and genetically informative analyses permitted quantification of environmental impact upon systemic vascular resistance responsivity and left ventricular mass. It was hypothesized that environmental influences (SES) accounted for a greater proportion of the variance in systemic vascular resistance responsivity and left ventricular mass in African Americans than Caucasian Americans. The hypothesis that systemic vascular resistance responsivity was a pathway through which SES exerted its influence on left ventricular mass was also tested.
The study has been extended through November 2005 to continue examination of the investigator's Twin CV Health cohort (519 pairs of twins who will be 14 to 25 years old). The study provides the unique opportunity to better understand the effects of sodium ion (Na+) retention as a mechanism augmenting systemic vascular resistance responsivity (SVR) and changes in vascular function (i.e., endothelium dependent arterial dilation; EDAD), ventricular structure (i.e., left ventricular mass; LVM) and 24-hour ambulatory BP (ABP). The specific aims are to determine: 1) To what extent is environmental stress related to stress induced Na+ retention, SVR responsivity and preclinical markers of essential hypertension risk and are these relationships stronger in African Americans than Caucasian Americans; 2) Whether stress induced Na+ retention is a pathway linking environmental stress with preclinical markers of essential hypertension risk; and 3) Whether behavioral factors (i.e. John Henryism, anger expression, social support, physical activity) moderate effects of environmental stress on stress induced Na+ retention and/or SVR responsivity and in the preclinical markers of essential hypertension risk, particularly in African Americans.
Given increasing awareness of the extent to which environments typically faced by ethnic groups differ, environmental influence on these processes may be an important factor that is an aspect of ethnicity. Socioeconomic status (SES) is a useful index of such environments and is associated with cardiovascular disease (CVD). Since behavior is one pathway through which SES influences are thought to be expressed in disease, this study focuses specifically on stress responsivity, which is thought to be linked to the pathophysiology of CVD. Since such disease has its antecedents in childhood, a multiethnic pediatric sample is employed. In addition, the subject sample consists of twins. Investigation of the impact of environments on the expression of CVD can be achieved only with proper control for biological influences.
DESIGN NARRATIVE:
Subjects completed three laboratory stressors: a video game task, a structured social interview, and the cold pressor. Stress responsivity was assessed, with particular interest being paid to systemic vascular resistance (SVR). Left ventricular mass (LVM) was also assessed. Sophisticated environmentally and genetically informative analyses permitted quantification of environmental impact upon systemic vascular resistance responsivity and left ventricular mass. It was hypothesized that environmental influences (SES) accounted for a greater proportion of the variance in systemic vascular resistance responsivity and left ventricular mass in African Americans than Caucasian Americans. The hypothesis that systemic vascular resistance responsivity was a pathway through which SES exerted its influence on left ventricular mass was also tested.
The study has been extended through November 2005 to continue examination of the investigator's Twin CV Health cohort (519 pairs of twins who will be 14 to 25 years old). The study provides the unique opportunity to better understand the effects of sodium ion (Na+) retention as a mechanism augmenting systemic vascular resistance responsivity (SVR) and changes in vascular function (i.e., endothelium dependent arterial dilation; EDAD), ventricular structure (i.e., left ventricular mass; LVM) and 24-hour ambulatory BP (ABP). The specific aims are to determine: 1) To what extent is environmental stress related to stress induced Na+ retention, SVR responsivity and preclinical markers of essential hypertension risk and are these relationships stronger in African Americans than Caucasian Americans; 2) Whether stress induced Na+ retention is a pathway linking environmental stress with preclinical markers of essential hypertension risk; and 3) Whether behavioral factors (i.e. John Henryism, anger expression, social support, physical activity) moderate effects of environmental stress on stress induced Na+ retention and/or SVR responsivity and in the preclinical markers of essential hypertension risk, particularly in African Americans.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: