Wounded Spirits, Ailing Hearts: Post-Traumatic Stress Disorder and Cardiovascular Disease in Indians

Completed

• Conditions: Cardiovascular Diseases; Heart Diseases
• Interventions: Procedure: PET Scans

• Registration Number: NCT00073788
• Lead Sponsor: University of Colorado, Denver

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 event(s). 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 (e.g., smoking, alcohol use, exercise, obesity), cultural (e.g., acculturation, religiosity), and biological (e.g., blood pressure, blood lipid and glucose concentrations) mediators in the relationship of PTSD with coronary flow reserve and HRV.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2003-12-08
• Study First Submitted QC: 2003-12-09
• Study First Posted: 2003-12-10
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-30
• Last Update Posted: 2014-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with PTSD	PET Scans	Subjects will be American Indian, between the ages of 18-68. Approximately 66% will be female, 33% male, which conforms to the distribution of PTSD in this population. Study group subjects will be PTSD positive. Overt CVD is exclusionary.
Control Group	PET Scans	Subjects will be American Indian, between the ages of 18-68. Approximately 66% will be female, 33% male, which conforms to the distribution of PTSD in this population. Control subjects will be PTSD negative. For both groups: overt CVD is exclusionary.

Primary Outcome Measures

Name	Time	Method
carotid intima-media thickness	study visit (PET scan)	Measured by PET Scan and ultrasound. The main outcome of the carotid ultrasound will be the mean intima-media thickness on the far wall of the common carotid artery.
coronary flow reserve	study visit	Measured by PET Scan. For coronary flow reserve, we will mainly focus on the overall measure of coronary flow reserve (as opposed to regional analysis), since this is thought to be appropriate for detection of early coronary disease.
Heart Rate Variation (HRV)	study visit	Measured by PET Scan. The main outcome for HRV will be the high frequency power.