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

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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
Sponsor:
Collaborator:
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

Tracking Information
First Submitted Date June 20, 2012
First Posted Date July 26, 2012
Last Update Posted Date April 29, 2013
Study Start Date April 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 23, 2012)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 23, 2012)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cardiovascular Risk Markers in Veterans With Post Traumatic Stress Disorder
Official Title Cardiovascular Risk Markers in Veterans With PTSD
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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.

Sampling Method Non-Probability Sample
Study Population OIF and OEF veterans within the VASDHS, who are between 28 and 38 years of age inclusively
Condition
  • Cardiovascular Disease
  • Post Traumatic Stress Disorder
Intervention Not Provided
Study Groups/Cohorts
  • Veterans with a history of PTSD
  • Veterans without a history of PTSD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: April 25, 2013)
13
Original Estimated Enrollment
 (submitted: July 23, 2012)
60
Actual Study Completion Date January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 28 Years to 38 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01650220
Other Study ID Numbers INTRuST-CV Markers
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Study Sponsor INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Collaborators U.S. Army Medical Research and Development Command
Investigators
Principal Investigator: Vibha Bhatnagar, MD University of California, San Diego
PRS Account INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Verification Date April 2013