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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

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

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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

Resource links provided by the National Library of Medicine

Veterans with a history of PTSD
Veterans without a history of PTSD

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01650220

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United States, California
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
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Principal Investigator: Vibha Bhatnagar, MD University of California, San Diego
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Responsible Party: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium Identifier: NCT01650220    
Other Study ID Numbers: INTRuST-CV Markers
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: April 29, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Cardiovascular Diseases
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders