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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL139614 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trauma exposed without PTSD | Individuals with a history of trauma exposure who do not have current PTSD |
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| Trauma exposed with PTSD | Individuals with a history of trauma exposure and a current diagnosis of PTSD |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychophysiological fear conditioning and extinction task | Behavioral | Behavioral task to assess psychophysiological measures of fear |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Circulating 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. |
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Inclusion Criteria:
Additional Inclusion Criteria for the PTSD Group
Exclusion Criteria:
Additional Exclusion Criteria for the Trauma-Exposed Matched Control Group
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Trauma-exposed adults without a history of cardiovascular disease recruited from the community
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer A Sumner, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33952541 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 1, 2026 | |
| Reset | Jun 25, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 3, 2024 | May 5, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 1, 2021 | May 5, 2026 | ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 1, 2026 | Jun 25, 2026 | |||
| Jun 25, 2026 |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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Blood and urine samples for inflammatory and oxidative stress biomarkers; a blood sample for DNA collection is an optional aspect of this study
| Eyetracking task | Behavioral | Behavioral task to assess dysphoria-relevant attention allocation |
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| Baseline |
| Circulating 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. | Baseline |