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

• ClinicalTrials.gov Identifier: NCT01650220
• Recruitment Status: Terminated
• First Posted: July 26, 2012
• Last Update Posted: April 29, 2013
• Sponsor: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
• Collaborator: U.S. Army Medical Research and Development Command
• Information provided by (Responsible Party): INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

Study Description

Brief Summary:

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.

Condition or disease
Cardiovascular Disease; Post Traumatic Stress Disorder

Study Design

• Study Type: Observational
• Actual Enrollment: 13 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• 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

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. Completion of serum lab measurements. [ Time Frame: 18months ]

Secondary Outcome Measures :

1. Carotid Intimal Medial Thickness (CIMT) measurement [ Time Frame: Within 4 months of subject recruitment ]
   CIMT thickness will be measured by carotid ultrasound
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 28 Years to 38 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Locations

United States, California

VASDHS

San Diego, California, United States, 92161

Sponsors and Collaborators

INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

U.S. Army Medical Research and Development Command

Investigators

• Principal Investigator: Vibha Bhatnagar, MD; University of California, San Diego

More Information

• Responsible Party: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
• ClinicalTrials.gov Identifier: NCT01650220
• Other Study ID Numbers: INTRuST-CV Markers
• First Posted: July 26, 2012
• Last Update Posted: April 29, 2013
• Last Verified: April 2013

Additional relevant MeSH terms:

Cardiovascular Diseases; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders