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

30 de mayo de 2014 actualizado por: University of Colorado, Denver
To evaluate Post-Traumatic Stress Disorder as a risk factor for cardiovascular disease in American Indians.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

267

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 68 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

American Indian people with, and without, PTSD

Descripción

Inclusion criteria

  • be 18 years of age or older;
  • not be pregnant, or breastfeeding;
  • be free of heart disease when they participated in the American Indian Services Utilization, Psychiatric Epidemiology, Risk and Protective Factors Project (AI-SUPERPFP); or change in PTSD status from time of participation to completion of 2nd stage screening;
  • have no medical issues that interfere with the PET imaging such as unstable angina, myocardial infarction in the past week, severe obstructive lung disease, decompensated heart failure; severe coronary disease, severe stroke, or other medical conditions that would make it unsafe for them to travel and complete the protocol (e.g., not be on dialysis);
  • not be taking any medications such as theophylline or aminophylline or oral steroids (e.g. prednisone);
  • participants who use inhalers or nebulizers will be asked to use the inhalers or nebulizers in Denver on their regular schedule. If they are able to administer these treatments themselves on their regular schedule, they are eligible to be brought to Denver, assuming other eligibility criteria are met.
  • and not have any conditions or devices, like claustrophobia that would interfere with the heart imaging process.
  • not be using alcohol or any illegal substances during Denver visit and examination period.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Subjects with PTSD
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.
PET Scan to look for coronary flow reserve, heart rate variability, and carotid ultrasound measures (mean intermediate thickness of the far fall of the carotid artery).
Control Group
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.
PET Scan to look for coronary flow reserve, heart rate variability, and carotid ultrasound measures (mean intermediate thickness of the far fall of the carotid artery).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
coronary flow reserve
Periodo de tiempo: 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.
study visit
Heart Rate Variation (HRV)
Periodo de tiempo: study visit
Measured by PET Scan. The main outcome for HRV will be the high frequency power.
study visit
carotid intima-media thickness
Periodo de tiempo: 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.
study visit (PET scan)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Spero M. Manson, PhD, University of Colorado, Denver

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 2003

Finalización primaria (Actual)

1 de agosto de 2008

Finalización del estudio (Actual)

1 de agosto de 2008

Fechas de registro del estudio

Enviado por primera vez

8 de diciembre de 2003

Primero enviado que cumplió con los criterios de control de calidad

9 de diciembre de 2003

Publicado por primera vez (Estimar)

10 de diciembre de 2003

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

2 de junio de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

30 de mayo de 2014

Última verificación

1 de mayo de 2014

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 03-1028
  • R01HL073824 (Subvención/contrato del NIH de EE. UU.)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Enfermedades cardíacas

Ensayos clínicos sobre PET Scans

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