TraumaNCT03778307
Key Dimensions of PTSD and ED
An observational study of Trauma and PTSD, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will test whether endothelial dysfunction could be the early subclinical mechanism by which posttraumatic stress disorder (PTSD) increases cardiovascular disease (CVD) risk, and whether posttraumatic fear-a key component of PTSD-or another PTSD dimension could be the target to offset that risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, PTSD, Endothelial Dysfunction
- What is being tested?
- Psychophysiological fear conditioning and extinction task and Eyetracking task
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2019to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Trauma-exposed adults without a history of cardiovascular disease recruited from the community
Who may be able to join
- Aged 18+ years
- History of exposure to a psychological trauma (e.g., natural disaster, physical assault)
- Fluent in English
- Willing to and capable of providing informed consent
- Additional Inclusion Criteria for the PTSD Group
- Diagnosed with current PTSD (duration of at least 1 month) using the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual 5th Edition (DSM-5) (CAPS-5) at the diagnostic interview assessment
Who cannot join
- History of CVD (i.e., diagnosis of myocardial infarction, unstable angina, heart failure, peripheral artery disease, or stroke)
- Deemed unable to comply with the protocol (either self-selected or by indicating during screening that could not complete all requested tasks)
- Current bipolar disorder or psychotic disorder
- Mild or more severe cognitive impairment [Mini-Mental State Exam (MMSE)3 score ≤18]
- Current moderate or severe substance use disorder
- Acute, unstable, or severe medical disorder or pregnancy
Show all 12Show fewer
- Deemed to need immediate psychiatric intervention (e.g., active suicidality)
- Use of antipsychotic, mood stabilizer, antidepressant, or stimulant medication in the past 4 weeks
- Daily benzodiazepine use in the past 2 weeks
- Additional Exclusion Criteria for the Trauma-Exposed Matched Control Group
- Current or past diagnosis of any DSM-5 psychiatric disorder
- CAPS-5 total score ≥25
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Key Dimensions of Post-traumatic Stress Disorder (PTSD) and Endothelial Dysfunction (ED)
This study will test whether endothelial dysfunction could be the early subclinical mechanism by which posttraumatic stress disorder (PTSD) increases cardiovascular disease (CVD) risk, and whether posttraumatic fear-a key component of PTSD-or another PTSD dimension could be the target to offset that risk. The results of this study may help trauma-exposed individuals who are at risk of having CVD events.
Read the detailed description
Posttraumatic stress disorder (PTSD) increases risk of incident cardiovascular disease (CVD) by 25-50%. Most individuals (50-90%) experience a traumatic event in their lifetime, and PTSD is the fifth most common psychiatric disorder. Experts have now called for increased CVD surveillance after trauma and for PTSD treatment trials powered to reduce CVD risk. However, both CVD risk and PTSD are complex phenomena that likely interact in nuanced ways. This study will determine which PTSD dimension(s) contribute to endothelial dysfunction, one of the earliest modifiable precursors to CVD. The investigators will examine cross-sectional and longitudinal associations of PTSD and its underlying dimensions with functional and, secondarily, cellular measures of endothelial dysfunction (FMD and circulating endothelial cell-derived microparticles, respectively) in a community-dwelling sample of CVD-free adult men and women with a history of trauma (50% with current PTSD).
- Conditions
- Trauma, PTSD, Endothelial Dysfunction
- Being tested
- Psychophysiological fear conditioning and extinction task, Eyetracking task
- Keywords
- Trauma, PTSD, Endothelial Dysfunction
- Medical subject headings
- Wounds and Injuries, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychophysiological fear conditioning and extinction taskBehavioural
Behavioral task to assess psychophysiological measures of fear
Eyetracking taskBehavioural
Behavioral task to assess dysphoria-relevant attention allocation
| Study group | Role | What they receive |
|---|---|---|
| Trauma exposed without PTSD | Individuals with a history of trauma exposure who do not have current PTSD Receives: Behavioral: Psychophysiological fear conditioning and extinction task; Behavioral: Eyetracking task | |
| Trauma exposed with PTSD | Individuals with a history of trauma exposure and a current diagnosis of PTSD Receives: Behavioral: Psychophysiological fear conditioning and extinction task; Behavioral: Eyetracking task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated Dilation of the Brachial Artery (FMD) %
FMD is the percent difference in diameter of the brachial artery, before and after occlusion. Impaired endothelial function occurs when blood vessels are unable to dilate fully in response to nitric oxide synthesis and release, which is manifested as impaired endothelium-dependent vasodilation (i.e., lower FMD). Lower FMD has been associated with the degree of coronary atherosclerosis and predicts CVD events.
Measured: Baseline
Secondary outcomes (2)
Circulating Endothelial Cell-derived Microparticles (EMPs) Expressing CD62E
EMPs expressing CD62E (i.e., endothelial cell activation) and CD31 (i.e., endothelial cell apoptosis) will be measured. Assessments of circulating EMPs will be measured using flow cytometry, and total flow cytometry counts will be converted to the number of EMPs per uL of blood. Higher concentrations of EMPs expressing CD62E and CD31 indicate greater endothelial dysfunction.
Measured: Baseline
Circulating Endothelial Cell-derived Microparticles (EMPs) Expressing CD31
EMPs expressing CD62E (i.e., endothelial cell activation) and CD31 (i.e., endothelial cell apoptosis) will be measured. Assessments of circulating EMPs will be measured using flow cytometry, and total flow cytometry counts will be converted to the number of EMPs per uL of blood. Higher concentrations of EMPs expressing CD62E and CD31 indicate greater endothelial dysfunction.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start20 Nov 2019
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jennifer A. Sumner, PhD, University of California, Los Angeles
- Investigators
- Jennifer A Sumner, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778307
- Sponsor's protocol ID
- AAAR8563
- Other IDs
- R01HL139614
- Status last verified
- Jul 2026
- First submitted
- 7 Dec 2018
- Last updated
- 24 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cleveland S, Reed K, Thomas JL, Ajijola OA, Ebrahimi R, Hsiai T, Lazarov A, Montoya AK, Neria Y, Shimbo D, Wolitzky-Taylor K, Sumner JA. Key dimensions of post-traumatic stress disorder and endothelial dysfunction: a protocol for a mechanism-focused cohort study. BMJ Open. 2021 May 5;11(5):e043060. doi: 10.1136/bmjopen-2020-043060.
PubMed 33952541
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Key Dimensions of Post-traumatic Stress Disorder (PTSD) and Endothelial Dysfunction (ED)
- ClinicalTrials.gov ID
- NCT03778307
- Acronym / sponsor ID
- AAAR8563
- Conditions
- Trauma, PTSD, Endothelial Dysfunction
- Keywords
- Trauma, PTSD, Endothelial Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Posted 24 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test whether endothelial dysfunction could be the early subclinical mechanism by which posttraumatic stress disorder (PTSD) increases cardiovascular disease (CVD) risk, and whether posttraumatic fear-a key component of PTSD-or another PTSD dimension could be the target to offset that risk. The results of this study may help trauma-exposed individuals who are at risk of having CVD events.
Detailed description
Posttraumatic stress disorder (PTSD) increases risk of incident cardiovascular disease (CVD) by 25-50%. Most individuals (50-90%) experience a traumatic event in their lifetime, and PTSD is the fifth most common psychiatric disorder. Experts have now called for increased CVD surveillance after trauma and for PTSD treatment trials powered to reduce CVD risk. However, both CVD risk and PTSD are complex phenomena that likely interact in nuanced ways. This study will determine which PTSD dimension(s) contribute to endothelial dysfunction, one of the earliest modifiable precursors to CVD. The investigators will examine cross-sectional and longitudinal associations of PTSD and its underlying dimensions with functional and, secondarily, cellular measures of endothelial dysfunction (FMD and circulating endothelial cell-derived microparticles, respectively) in a community-dwelling sample of CVD-free adult men and women with a history of trauma (50% with current PTSD).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trauma exposed without PTSD | – | Behavioral: Psychophysiological fear conditioning and extinction task, Behavioral: Eyetracking taskIndividuals with a history of trauma exposure who do not have current PTSD |
| Trauma exposed with PTSD | – | Behavioral: Psychophysiological fear conditioning and extinction task, Behavioral: Eyetracking taskIndividuals with a history of trauma exposure and a current diagnosis of PTSD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Trauma-exposed adults without a history of cardiovascular disease recruited from the community
Key inclusion criteria (6 listed)
- Aged 18+ years
- History of exposure to a psychological trauma (e.g., natural disaster, physical assault)
- Fluent in English
- Willing to and capable of providing informed consent
- Additional Inclusion Criteria for the PTSD Group
Key exclusion criteria (12 listed)
- History of CVD (i.e., diagnosis of myocardial infarction, unstable angina, heart failure, peripheral artery disease, or stroke)
- Deemed unable to comply with the protocol (either self-selected or by indicating during screening that could not complete all requested tasks)
- Current bipolar disorder or psychotic disorder
- Mild or more severe cognitive impairment [Mini-Mental State Exam (MMSE)3 score ≤18]
- Current moderate or severe substance use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychophysiological fear conditioning and extinction taskBehavioral task to assess psychophysiological measures of fear | Behavioural | Trauma exposed with PTSD, Trauma exposed without PTSD |
| Eyetracking taskBehavioral task to assess dysphoria-relevant attention allocation | Behavioural | Trauma exposed with PTSD, Trauma exposed without PTSD |
Primary outcome
Flow-mediated Dilation of the Brachial Artery (FMD) %
Time frame: Baseline
FMD is the percent difference in diameter of the brachial artery, before and after occlusion. Impaired endothelial function occurs when blood vessels are unable to dilate fully in response to nitric oxide synthesis and release, which is manifested as impaired endothelium-dependent vasodilation (i.e., lower FMD). Lower FMD has been associated with the degree of coronary atherosclerosis and predicts CVD events.
2 secondary outcomes
Circulating Endothelial Cell-derived Microparticles (EMPs) Expressing CD62E
Time frame: Baseline
Circulating Endothelial Cell-derived Microparticles (EMPs) Expressing CD31
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33952541Cleveland S, Reed K, Thomas JL, Ajijola OA, Ebrahimi R, Hsiai T, Lazarov A, Montoya AK, Neria Y, Shimbo D, Wolitzky-Taylor K, Sumner JA. Key dimensions of post-traumatic stress disorder and endothelial dysfunction: a protocol for a mechanism-focused cohort study. BMJ Open. 2021 May 5;11(5):e043060. doi: 10.1136/bmjopen-2020-043060.
- Individual participant dataSharing planned: No
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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.
Jennifer A Sumner, PhD principal investigator
University of California, Los Angeles
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 Trauma and PTSD, run by University of California, Los Angeles 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 12 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: finished, as of the sponsor's last update on 24 Jul 2026. 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?
Yes. Results are posted in the registry (first posted 24 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Flow-mediated Dilation of the Brachial Artery (FMD) % (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03778307, which also lists 1 linked publication.
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 24 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.