Cardiovascular Risk Markers in Veterans With Post Traumatic Stress Disorder

NCT ID: NCT01650220

Last Updated: 2013-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-01-31

Brief Summary

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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

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Conditions

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Cardiovascular Disease Post Traumatic Stress Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Veterans with a history of PTSD

No interventions assigned to this group

Veterans without a history of PTSD

No interventions assigned to this group

Eligibility Criteria

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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

* 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
Minimum Eligible Age

28 Years

Maximum Eligible Age

38 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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U.S. Army Medical Research and Development Command

FED

Sponsor Role collaborator

INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vibha Bhatnagar, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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VASDHS

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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INTRuST-CV Markers

Identifier Type: -

Identifier Source: org_study_id

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