Cardiovascular Risk Markers in Veterans With Post Traumatic Stress Disorder

Study Overview
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Brief Summary
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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.

Official Title
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Cardiovascular Risk Markers in Veterans With PTSD

Conditions
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Cardiovascular Disease, Post Traumatic Stress Disorder

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 28 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Veterans with a history of PTSD<br> | |
| Veterans without a history of PTSD<br> | |

What is the study measuring?
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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 |