Cardiovascular Risk Markers in Veterans With Post Traumatic Stress Disorder

Cardiovascular Disease Clinical Trial

— CVMarkers  

Official title:

Cardiovascular Risk Markers in Veterans With PTSD

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01650220
• Other study ID #: INTRuST-CV Markers
• Status: Terminated
• Phase: N/A
• First received: June 20, 2012
• Last updated: April 25, 2013
• Start date: April 2012
• Est. completion date: January 2013

Study information

• Verified date: April 2013
• Source: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 28 Years to 38 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Locations

Country	Name	City	State
United States	VASDHS	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium	U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Completion of serum lab measurements.		18months	No
Secondary	Carotid Intimal Medial Thickness (CIMT) measurement	CIMT thickness will be measured by carotid ultrasound	Within 4 months of subject recruitment	No
Secondary	Cardiovascular Disease Biomarkers	Serum C-reactive protein and interleukin-6 will be measured	Within 6 months of subject recruitment	No