Cardiovascular DiseaseCVMarkersNCT01650220
Cardiovascular Risk Markers in Veterans With Post Traumatic Stress Disorder
An observational study of Cardiovascular Disease and Post Traumatic Stress Disorder, run by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 28 to 38 years
- Conditions the study is for
- Cardiovascular Disease, Post Traumatic Stress Disorder
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 38 years
- All sexes
- No healthy volunteers
- Adult
Study population: OIF and OEF veterans within the VASDHS, who are between 28 and 38 years of age inclusively
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Risk Markers in Veterans With PTSD
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.
- Medical subject headings
- Cardiovascular Diseases, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Veterans with a history of PTSD | Not described | |
| Veterans without a history of PTSD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18months
Completion of serum lab measurements.
Measured: 18months
Secondary outcomes (2)
Carotid Intimal Medial Thickness (CIMT) measurement
CIMT thickness will be measured by carotid ultrasound
Measured: Within 4 months of subject recruitment
Cardiovascular Disease Biomarkers
Serum C-reactive protein and interleukin-6 will be measured
Measured: Within 6 months of subject recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startApr 2012
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: The funding agency, DoD, determined that the study could not meet its enrollment numbers by the end of the grant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Vibha Bhatnagar, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650220
- Sponsor's protocol ID
- INTRuST-CV Markers
- Acronym
- CVMarkers
- Status last verified
- Apr 2013
- First submitted
- 20 Jun 2012
- Last updated
- 29 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Markers in Veterans With PTSD
- ClinicalTrials.gov ID
- NCT01650220
- Acronym / sponsor ID
- CVMarkers / INTRuST-CV Markers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The funding agency, DoD, determined that the study could not meet its enrollment numbers by the end of the grant
- Enrolment
- 13 participants (actual)
- Lead sponsor
- INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical ConsortiumUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Apr 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 26 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Veterans with a history of PTSD | – | – |
| Veterans without a history of PTSD | – | – |
Who may qualify
- Ages
- 28 to 38 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- OIF and OEF veterans within the VASDHS, who are between 28 and 38 years of age inclusively
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Carotid Intimal Medial Thickness (CIMT) measurement
Time frame: Within 4 months of subject recruitment
Cardiovascular Disease Biomarkers
Time frame: Within 6 months of subject recruitment
Results and safety
The study was stopped early (reason given: The funding agency, DoD, determined that the study could not meet its enrollment numbers by the end of the grant). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vibha Bhatnagar, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease and Post Traumatic Stress Disorder, run by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The funding agency, DoD, determined that the study could not meet its enrollment numbers by the end of the grant). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment methods feasibility (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2013.