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

This study is ongoing, but not recruiting participants.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00073788
  Purpose

To evaluate Post-Traumatic Stress Disorder as a risk factor for cardiovascular disease in American Indians.


Condition
Cardiovascular Diseases
Heart Diseases

MedlinePlus related topics:   Heart Diseases    Post-Traumatic Stress Disorder    Stress   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Natural History, Case Control

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:   September 2003
Estimated Study Completion Date:   August 2008

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.

  Eligibility
Ages Eligible for Study:   18 Years to 52 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

No eligibility criteria

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073788

Sponsors and Collaborators

Investigators
Investigator:     Spero Manson     University of Colorado at Denver and Health Sciences Center    
  More Information


Study ID Numbers:   1240
First Received:   December 8, 2003
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00073788
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Heart Diseases
Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 30, 2008




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