Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-01-02 @ 1:32 AM
Study NCT ID:
NCT00005435
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hostility and Pathogenic Mechanisms of Coronary Heart Disease in Women
Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-06
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 determine the combined effects of hostility, harassment, lipids, and oral contraceptive (0C) use on physiological responses in young and middle-aged premenopausal women.
Detailed Description:
BACKGROUND:
Preliminary findings already have shown that, in contrast to women with low scores on the Cook and Medley Hostility (Ho) scale, women with high Ho scores exhibit greater cardiovascular changes to harassment. Additional findings have suggested that oral contraceptive (0C) use may also be associated with increased behaviorally-induced physiological changes, especially in low Ho women. Similarly, higher levels of total serum cholesterol (TSC) have been positively associated with greater stress-induced neurohormonal changes in middle-aged men with high Ho scores.
DESIGN NARRATIVE:
Assessment of autonomic activity took place in the laboratory and during a 24 hour ambulatory measurement period. Hostility was measured with the Cook and Medley Hostility scale. The laboratory assessment helped to determine if high hostility women responded to harassment with greater cardiovascular and neurohormonal changes than low hostility women, and if this relationship was altered by 0C use, lipids, and age. The ambulatory assessment of autonomic activity allowed an exploration of the responses of high and low hostility subjects to daily-life stressors. Several hypothesis were explored: 1) Did harassment produce neuroendocrine as well as cardiovascular hyperreactivity in young women, and did this hyperreactivity generalize from laboratory to real-life? 2) Were the harassment-induced cardiovascular and neuroendocrine changes in young women also present in middle-aged women? 3) To what extent did 0C use modulate the cardiovascular and neuroendocrine responses to harassment in young women, and was 0C use also altering the hostility--related associations between lipids and reactivity? 4) Were the differential lipid-reactivity associations observed in middle-aged men as a function of high and low hostility scores present in women, and, if so, were they modulated by age?
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Preliminary findings already have shown that, in contrast to women with low scores on the Cook and Medley Hostility (Ho) scale, women with high Ho scores exhibit greater cardiovascular changes to harassment. Additional findings have suggested that oral contraceptive (0C) use may also be associated with increased behaviorally-induced physiological changes, especially in low Ho women. Similarly, higher levels of total serum cholesterol (TSC) have been positively associated with greater stress-induced neurohormonal changes in middle-aged men with high Ho scores.
DESIGN NARRATIVE:
Assessment of autonomic activity took place in the laboratory and during a 24 hour ambulatory measurement period. Hostility was measured with the Cook and Medley Hostility scale. The laboratory assessment helped to determine if high hostility women responded to harassment with greater cardiovascular and neurohormonal changes than low hostility women, and if this relationship was altered by 0C use, lipids, and age. The ambulatory assessment of autonomic activity allowed an exploration of the responses of high and low hostility subjects to daily-life stressors. Several hypothesis were explored: 1) Did harassment produce neuroendocrine as well as cardiovascular hyperreactivity in young women, and did this hyperreactivity generalize from laboratory to real-life? 2) Were the harassment-induced cardiovascular and neuroendocrine changes in young women also present in middle-aged women? 3) To what extent did 0C use modulate the cardiovascular and neuroendocrine responses to harassment in young women, and was 0C use also altering the hostility--related associations between lipids and reactivity? 4) Were the differential lipid-reactivity associations observed in middle-aged men as a function of high and low hostility scores present in women, and, if so, were they modulated by age?
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R29HL046283 | NIH | None | https://reporter.nih.gov/quic… | View |