Cardiovascular Risk Markers in Veterans With Post Traumatic Stress Disorder

INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium13 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Cardiovascular Disease Post Traumatic Stress Disorder

Eligibility

Sex: ALLMin age: 28 YearsMax age: 38 Years

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 18months

Completion of serum lab measurements.

Time frame: 18months

Secondary Outcomes

Carotid Intimal Medial Thickness (CIMT) measurement

CIMT thickness will be measured by carotid ultrasound

Time frame: Within 4 months of subject recruitment

Cardiovascular Disease Biomarkers

Serum C-reactive protein and interleukin-6 will be measured

Time frame: Within 6 months of subject recruitment