Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073788
Status:
COMPLETED
Last Update Posted:
2014-06-02
First Post:
2003-12-08
Brief Title:
Wounded Spirits Ailing Hearts Post-Traumatic Stress Disorder and Cardiovascular Disease in Indians
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Wounded Spirits Ailing Hearts Post-Traumatic Stress Disorder and Cardiovascular Disease in Indians
Status:
COMPLETED
Status Verified Date:
2014-05
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:
To evaluate Post-Traumatic Stress Disorder as a risk factor for cardiovascular disease in American Indians
Detailed Description:
BACKGROUND
Post-Traumatic Stress Disorder PTSD is a unique psychiatric condition characterized by a persistent maladaptive reaction resulting from exposure to a stressful traumatic events In the United States general population PTSD has a lifetime prevalence of 5 percent in men and 10 percent in women PTSD is known to produce alternations in the central and autonomic nervous system and hormonal dysregulation However little is known about the long-term consequences of PTSD on the cardiovascular system PTSD is a common disorder among reservation dwelling American Indians with a life-time prevalence of 12 percent in men and 23 percent in women Similarly cardiovascular disease CVD has emerged as a major health problem in American Indians during the past decade
DESIGN NARRATIVE
The study examines the relationship between PTSD and cardiac function in a population-based sample of American Indians The technical aims of this study involve 1 the identification of American Indian men and women ages 18-52 who have a lifetime history of PTSD and are free from overt CVD 2 the selection of an age- sex- and tribe-matched comparison group of American Indians who have no history of PTSD and are free from known CVD 3 a comprehensive lifestyle and clinical evaluation of the PTSD and non-PTSD groups to assess CVD risk factors such as smoking exercise obesity blood pressure concentrations of blood lipids and inflammatory and thrombogenic factors and 4 a set of non-invasive tests of subclinical CVD and other measures of CVD risk These tests include positron emission tomography PET myocardial perfusion imaging to examine coronary flow reserve high-resolution ultrasound of the carotid arteries to measure carotid intima-media thickness high-resolution ultrasound of the brachial artery to determine flow-mediated vasodilation and ambulatory electrocardiographic monitoring to assess heart rate variability HRV With these data the study addresses the specific aims which are 1 to determine whether individuals with PTSD compared with those without PTSD show greater evidence of subclinical CVD including a lower coronary flow reserve increased carotid intimamedia thickness and reduced forearm flow-mediated vasodilation 2 to ascertain whether HRV is lower in individuals with PTSD compared to those without PTSD and 3 to investigate the role of lifestyle eg smoking alcohol use exercise obesity cultural eg acculturation religiosity and biological eg blood pressure blood lipid and glucose concentrations mediators in the relationship of PTSD with coronary flow reserve and HRV
Post-Traumatic Stress Disorder PTSD is a unique psychiatric condition characterized by a persistent maladaptive reaction resulting from exposure to a stressful traumatic events In the United States general population PTSD has a lifetime prevalence of 5 percent in men and 10 percent in women PTSD is known to produce alternations in the central and autonomic nervous system and hormonal dysregulation However little is known about the long-term consequences of PTSD on the cardiovascular system PTSD is a common disorder among reservation dwelling American Indians with a life-time prevalence of 12 percent in men and 23 percent in women Similarly cardiovascular disease CVD has emerged as a major health problem in American Indians during the past decade
DESIGN NARRATIVE
The study examines the relationship between PTSD and cardiac function in a population-based sample of American Indians The technical aims of this study involve 1 the identification of American Indian men and women ages 18-52 who have a lifetime history of PTSD and are free from overt CVD 2 the selection of an age- sex- and tribe-matched comparison group of American Indians who have no history of PTSD and are free from known CVD 3 a comprehensive lifestyle and clinical evaluation of the PTSD and non-PTSD groups to assess CVD risk factors such as smoking exercise obesity blood pressure concentrations of blood lipids and inflammatory and thrombogenic factors and 4 a set of non-invasive tests of subclinical CVD and other measures of CVD risk These tests include positron emission tomography PET myocardial perfusion imaging to examine coronary flow reserve high-resolution ultrasound of the carotid arteries to measure carotid intima-media thickness high-resolution ultrasound of the brachial artery to determine flow-mediated vasodilation and ambulatory electrocardiographic monitoring to assess heart rate variability HRV With these data the study addresses the specific aims which are 1 to determine whether individuals with PTSD compared with those without PTSD show greater evidence of subclinical CVD including a lower coronary flow reserve increased carotid intimamedia thickness and reduced forearm flow-mediated vasodilation 2 to ascertain whether HRV is lower in individuals with PTSD compared to those without PTSD and 3 to investigate the role of lifestyle eg smoking alcohol use exercise obesity cultural eg acculturation religiosity and biological eg blood pressure blood lipid and glucose concentrations mediators in the relationship of PTSD with coronary flow reserve and HRV
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 |
|---|---|---|---|
| R01HL073824 | NIH | None | httpsreporternihgovquickSearchR01HL073824 |