Cardiovascular Risk Markers in Veterans With Post Traumatic Stress Disorder

Terminated

• Conditions: Cardiovascular Disease; Post Traumatic Stress Disorder

• Registration Number: NCT01650220
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-06-20
• Study First Submitted QC: 2012-07-23
• Study First Posted: 2012-07-26
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-25
• Last Update Posted: 2013-04-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recruitment methods feasibility	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.	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	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.	18months	Rate of clinical read will help in determining adequate staffing requirements for a larger study.
Completion of serum lab measurements.	18months

Secondary Outcome Measures

Name	Time	Method
Carotid Intimal Medial Thickness (CIMT) measurement	Within 4 months of subject recruitment	CIMT thickness will be measured by carotid ultrasound
Cardiovascular Disease Biomarkers	Within 6 months of subject recruitment	Serum C-reactive protein and interleukin-6 will be measured

Trial Locations

Locations (1)

VASDHS; 🇺🇸 San Diego, California, United States