Cardiovascular Risk Markers in Veterans With Post Traumatic Stress Disorder (CVMarkers)
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.
Post Traumatic Stress Disorder
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Cardiovascular Risk Markers in Veterans With PTSD|
- Recruitment methods feasibility [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
- Completion of structured diagnostic interview within 2hrs. [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
- Ability to schedule Carotid Intima-Media Thickness (CIMT) ultrasound in the Vascular Lab at VA San Diego Healthcare Systems, within 4 months of enrollment [ Time Frame: 18months ] [ Designated as safety issue: No ]Determining whether the Vascular Lab has the capacity for a larger clinical study will be informative in planning larger prospective studies.
- Time from CIMT completion to completion of clinical read. [ Time Frame: 18months ] [ Designated as safety issue: No ]Rate of clinical read will help in determining adequate staffing requirements for a larger study.
- Completion of serum lab measurements. [ Time Frame: 18months ] [ Designated as safety issue: No ]
- Carotid Intimal Medial Thickness (CIMT) measurement [ Time Frame: Within 4 months of subject recruitment ] [ Designated as safety issue: No ]CIMT thickness will be measured by carotid ultrasound
- Cardiovascular Disease Biomarkers [ Time Frame: Within 6 months of subject recruitment ] [ Designated as safety issue: No ]Serum C-reactive protein and interleukin-6 will be measured
Biospecimen Retention: Samples With DNA
For the assessment of CVD risk, high-sensitivity CRP (hs-CRP) measurements will be used. Standard assays detect 1,000 fold increases in CRP in response to infection or inflammation; these high levels cannot be used to stratify with respect to CVD risk. Hs-CRP, however, measurement can detect CRP levels as low as 0.5 mg/L. Though mainly used for research purposes, high-sensitivity IL-6 assays are also able to discriminate IL-6 levels within the normal range for CVD risk stratification. Both CRP and IL-6 levels will be analyzed as continuous quantitative traits.
Though no DNA analysis is planned for this study, subjects are asked if they are willing to have their samples banked for future research.
|Study Start Date:||April 2012|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|Veterans with a history of PTSD|
|Veterans without a history of PTSD|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650220
|United States, California|
|San Diego, California, United States, 92161|
|Principal Investigator:||Vibha Bhatnagar, MD||University of California, San Diego|