Cardiovascular Risk Markers in Veterans With Post Traumatic Stress Disorder (CVMarkers)

Cardiovascular Risk Markers in Veterans With PTSD

This is an observational study designed to determine whether veterans with PTSD have a higher risk of heart disease than those without PTSD. Cardiovascular risk will be assessed by interview and review of medical records, carotid artery ultrasound, and blood tests measuring markers of inflammation. Study participation is approximately 6 months. The eligible study population is veterans of Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF), age 28 through 38 years.

Study Overview

• Status: Terminated
• Conditions: Cardiovascular Disease; Post Traumatic Stress Disorder

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161
      • VASDHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

OIF and OEF veterans within the VASDHS, who are between 28 and 38 years of age inclusively

Description

Inclusion Criteria:

• OEF/OIF veterans at the VASDHS
• Between 28 and 38 years of age
• Willing to complete structured diagnostic interview for PTSD, CIMT ultrasound and blood test
• Willing to have a review of their medical records
• Able to give informed consent
• Have a negative urine pregnancy test, if a woman of child-bearing age

Exclusion Criteria:

• Do not meet inclusion criteria
• History of schizophrenia, other neurocognitive illness (including severe TBI by INTRuST criteria)) or active alcohol and/or drug abuse determined by chart review, interview or AUDIT-C score
• Inability to complete study tests within 18 months of study start
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Veterans with a history of PTSD
Veterans without a history of PTSD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment methods feasibility	Comparison of the number of participants per month recruited from medical providers (with/without PTSD) vs. response to recruitment fliers (with/without PTSD) in the first 12 months of the study. Selection bias to be determined by looking at differences in age and co-morbid illnesses.	12 months
Completion of structured diagnostic interview within 2hrs.	Completion of Clinician Assessed PTSD Scale (CAPS), Alcohol Use Disorders Identification Test-Consumption (AUDIT-C), Patient Health Questionnaire-9 (PHQ-9), Pittsburgh Sleep Quality Index (PSQI), INTRuST Uniformed Data Set, and Family History of heart disease, within 2hrs.	12 months
Ability to schedule Carotid Intima-Media Thickness (CIMT) ultrasound in the Vascular Lab at VA San Diego Healthcare Systems, within 4 months of enrollment	Determining whether the Vascular Lab has the capacity for a larger clinical study will be informative in planning larger prospective studies.	18months
Time from CIMT completion to completion of clinical read.	Rate of clinical read will help in determining adequate staffing requirements for a larger study.	18months
Completion of serum lab measurements.		18months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carotid Intimal Medial Thickness (CIMT) measurement	CIMT thickness will be measured by carotid ultrasound	Within 4 months of subject recruitment
Cardiovascular Disease Biomarkers	Serum C-reactive protein and interleukin-6 will be measured	Within 6 months of subject recruitment

Collaborators and Investigators

• Sponsor: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
• Collaborators: U.S. Army Medical Research and Development Command
• Investigators: Principal Investigator: Vibha Bhatnagar, MD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: June 20, 2012
• First Submitted That Met QC Criteria: July 23, 2012
• First Posted (Estimate): July 26, 2012

Study Record Updates

• Last Update Posted (Estimate): April 29, 2013
• Last Update Submitted That Met QC Criteria: April 25, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Cardiovascular Diseases; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: INTRuST-CV Markers