Cardiovascular Risk Markers in Veterans With Post Traumatic Stress Disorder

NCT01650220 | Terminated DMC

• 1 other identifier: INTRuST-CV Markers
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (5)

• Recruitment methods feasibility

  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.

  12 months

• Completion of structured diagnostic interview within 2hrs.

  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.

  12 months

• Ability to schedule Carotid Intima-Media Thickness (CIMT) ultrasound in the Vascular Lab at VA San Diego Healthcare Systems, within 4 months of enrollment

  Determining whether the Vascular Lab has the capacity for a larger clinical study will be informative in planning larger prospective studies.

  18months

• Time from CIMT completion to completion of clinical read.

  Rate of clinical read will help in determining adequate staffing requirements for a larger study.

  18months

• Completion of serum lab measurements.

  18months

Secondary Outcomes (2)

• Carotid Intimal Medial Thickness (CIMT) measurement

  Within 4 months of subject recruitment

• Cardiovascular Disease Biomarkers

  Within 6 months of subject recruitment

Study Arms (2)

Veterans with a history of PTSD

Veterans without a history of PTSD

Eligibility Criteria

• Age: 28 Years - 38 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

VASDHS

San Diego, California, 92161, United States

Location

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.

MeSH Terms

Conditions

Cardiovascular Diseases; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Vibha Bhatnagar, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: July 26, 2012
• Study Start: April 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: April 29, 2013

Record last verified: 2013-04

Locations

US (1)