Cardiovascular Risk Markers in Veterans With Post Traumatic Stress Disorder (CVMarkers)
|ClinicalTrials.gov Identifier: NCT01650220|
Recruitment Status : Terminated (The funding agency, DoD, determined that the study could not meet its enrollment numbers by the end of the grant)
First Posted : July 26, 2012
Last Update Posted : April 29, 2013
|Condition or disease|
|Cardiovascular Disease Post Traumatic Stress Disorder|
|Study Type :||Observational|
|Actual Enrollment :||13 participants|
|Official Title:||Cardiovascular Risk Markers in Veterans With PTSD|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
|Veterans with a history of PTSD|
|Veterans without a history of PTSD|
- Recruitment methods feasibility [ Time Frame: 12 months ]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 ]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 ]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 ]Rate of clinical read will help in determining adequate staffing requirements for a larger study.
- Completion of serum lab measurements. [ Time Frame: 18months ]
- Carotid Intimal Medial Thickness (CIMT) measurement [ Time Frame: Within 4 months of subject recruitment ]CIMT thickness will be measured by carotid ultrasound
- Cardiovascular Disease Biomarkers [ Time Frame: Within 6 months of subject recruitment ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650220
|United States, California|
|San Diego, California, United States, 92161|
|Principal Investigator:||Vibha Bhatnagar, MD||University of California, San Diego|