StressNCT06557707
Cardiovascular Health & Early Stress
An observational study of Stress, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Childhood adversity is highly prevalent, with 59% of the U.S. population reporting at least one adverse childhood experience (ACE). Substantial evidence links childhood adversity to cardiometabolic disease later in the life course, including heart disease, diabetes, and stroke, which are 3 of the top 10 causes of… Read more about this study
- Who is it for?
- Ages 9 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Childhood stress
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2022to 25 Jun 2025
- 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 9 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children and young individuals who have been exposed to adversity during childhood
Who may be able to join
- Cohort 1
- Men and pre-menopausal women
- 18-30 years old
- Cohort 2
- males and females
- 9-17 years old
Who cannot join
- Cohort 1
- Evidence of cardiovascular, pulmonary, renal, hepatic or cerebral diseases
- Evidence of pregnancy or currently nursing.
- Having a history of chronic pain
- Having a history of rheumatoid arthritis
- Cohort 2
Show all 10Show fewer
- Evidence of cardiovascular, pulmonary, renal, hepatic or cerebral diseases
- Evidence of pregnancy or currently nursing.
- Having a history of chronic pain
- Having a history of rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Childhood adversity is highly prevalent, with 59% of the U.S. population reporting at least one adverse childhood experience (ACE). Substantial evidence links childhood adversity to cardiometabolic disease later in the life course, including heart disease, diabetes, and stroke, which are 3 of the top 10 causes of mortality in the United States.
ACEs encompass many possible traumatic and distressing experiences, including abuse, neglect, or severe household dysfunctions. It is not surprising that the experience of those extreme events during the first decade of life has tremendous implications for the individual's psychological and physical health.
Read the detailed description
Current knowledge supports that ACEs trigger emotional stress, anxiety, fear, and discomfort in the individual. Acute and intense mental stress leads to structural changes in the amygdala, prolonged activation of the hypothalamic-pituitary-adrenal axis, and hyperactivation of the sympathetic nervous system. Then, the body secretes hormones to activate the cardiovascular system to cope with stress with a rapid increase in arterial pressure and heart rate. If the trauma is severe and/or repeated, the resting state for heart rate and blood pressure are readjusted, resulting in these children living in a heightened physiological state of arousal, including higher heart and respiration rates. This status leads to endothelial dysfunction and atherothrombotic activation that can contribute to premature cardiovascular dysfunctions. Notably, there is evidence of a cumulative effect, or dose-response relationship, between the number of reported ACEs and the prevalence of health risk behaviors and chronic diseases. Thus, despite the prevalence of ACEs and the impact on health and society, the mechanisms underlying these dysfunctions are still poorly understood. The present study aims to understand the impact of different types of ACEs on cardiovascular health.
- Conditions
- Stress
- Being tested
- Childhood stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Childhood stressOther
Based on stress-related information, participants will be divided into those who were exposed to adversity during childhood and those who were not exposed.
| Study group | Role | What they receive |
|---|---|---|
| Young individuals ACE (ages 18-30 years old) | Young individuals who experienced accumulative adverse childhood experiences Receives: Other: Childhood stress | |
| Children ACE (ages 9-17 years old) | Children who experienced accumulative adverse childhood experiences . Receives: Other: Childhood stress | |
| Young individuals No ACE (ages 18-30 years old) | Young individuals who have not experienced accumulative adverse childhood experiences | |
| Children No ACE (ages 9-17 years old) | Children who have not experienced accumulative adverse childhood experiences. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular function
This test examines how the blood vessels respond to different challenges and expand. It is used to characterize the cardiovascular health of the subject's blood vessels. Different events and substances will be used (under an IND) to test how the blood vessels react. The test is completed using Laser Doppler Speckle Contrast. We will measure how much the blood vessels dilate. Greater dilation, better vascular function.
Measured: Baseline
Cardiac Function
An evaluation of cardiac response will be monitored non-invasively. We will use ultrasound to visualize the heart and the blood vessels.
Measured: Baseline
Cardiac MRI (CMR)
Cardiac MRI will be completed to monitor early signs of poor functionality.
Measured: Baseline
Secondary outcomes (7)
Spirometry
Subjects will undergo a lung function test to measure how well their lungs work. The volume of air moving in and out of the lungs will be assessed. FEV1 will be evaluated. FEV1 is the amount of air a person can exhale in the first second after inhaling as deeply as possible.
Measured: Baseline
Lung Diffusing Capacity
Subjects will undergo a lung function test to measure how well their air is diffused from their lungs. DLCO will be evaluated. DLCO stands for diffusing capacity of the lungs for carbon monoxide, and it's a pulmonary function test that measures how well oxygen moves from the lungs into the bloodstream.
Measured: Baseline
Complete blood count
Blood analysis
Measured: Baseline
HbA1c
Blood analysis
Measured: Baseline
C-Reactive protein
Blood analysis
Measured: Baseline
Questionnaires
Lifestyle and stress related questionnaires will be completed by the participants including lifestyle, adversity during childhood, stress risk.
Measured: Baseline
Arterial Stiffness
A non-invasive assessment will be used to measure how fast the participant's blood travels, which is a measure of how stiff their arteries are.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start20 Jan 2022
- Primary completion25 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula Rodriguez Miguelez, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557707
- Sponsor's protocol ID
- HM20021768
- Status last verified
- Sep 2026
- First submitted
- 30 May 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Health & Early Stress
- ClinicalTrials.gov ID
- NCT06557707
- Acronym / sponsor ID
- HM20021768
- Conditions
- Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 16 Aug 2024 (actual)
- 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.
Childhood adversity is highly prevalent, with 59% of the U.S. population reporting at least one adverse childhood experience (ACE). Substantial evidence links childhood adversity to cardiometabolic disease later in the life course, including heart disease, diabetes, and stroke, which are 3 of the top 10 causes of mortality in the United States.
ACEs encompass many possible traumatic and distressing experiences, including abuse, neglect, or severe household dysfunctions. It is not surprising that the experience of those extreme events during the first decade of life has tremendous implications for the individual's psychological and physical health.
Detailed description
Current knowledge supports that ACEs trigger emotional stress, anxiety, fear, and discomfort in the individual. Acute and intense mental stress leads to structural changes in the amygdala, prolonged activation of the hypothalamic-pituitary-adrenal axis, and hyperactivation of the sympathetic nervous system. Then, the body secretes hormones to activate the cardiovascular system to cope with stress with a rapid increase in arterial pressure and heart rate. If the trauma is severe and/or repeated, the resting state for heart rate and blood pressure are readjusted, resulting in these children living in a heightened physiological state of arousal, including higher heart and respiration rates. This status leads to endothelial dysfunction and atherothrombotic activation that can contribute to premature cardiovascular dysfunctions. Notably, there is evidence of a cumulative effect, or dose-response relationship, between the number of reported ACEs and the prevalence of health risk behaviors and chronic diseases. Thus, despite the prevalence of ACEs and the impact on health and society, the mechanisms underlying these dysfunctions are still poorly understood. The present study aims to understand the impact of different types of ACEs on cardiovascular health.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Young individuals ACE (ages 18-30 years old) | – | Other: Childhood stressYoung individuals who experienced accumulative adverse childhood experiences |
| Children ACE (ages 9-17 years old) | – | Other: Childhood stressChildren who experienced accumulative adverse childhood experiences . |
| Young individuals No ACE (ages 18-30 years old) | – | –Young individuals who have not experienced accumulative adverse childhood experiences |
| Children No ACE (ages 9-17 years old) | – | –Children who have not experienced accumulative adverse childhood experiences. |
Who may qualify
- Ages
- 9 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children and young individuals who have been exposed to adversity during childhood
Key inclusion criteria (6 listed)
- Cohort 1
- Men and pre-menopausal women
- 18-30 years old
- Cohort 2
- males and females
Key exclusion criteria (10 listed)
- Cohort 1
- Evidence of cardiovascular, pulmonary, renal, hepatic or cerebral diseases
- Evidence of pregnancy or currently nursing.
- Having a history of chronic pain
- Having a history of rheumatoid arthritis
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 |
|---|---|---|
| Childhood stressBased on stress-related information, participants will be divided into those who were exposed to adversity during childhood and those who were not exposed. | Other | Children ACE (ages 9-17 years old), Young individuals ACE (ages 18-30 years old) |
Primary outcome
Vascular function
Time frame: Baseline
This test examines how the blood vessels respond to different challenges and expand. It is used to characterize the cardiovascular health of the subject's blood vessels. Different events and substances will be used (under an IND) to test how the blood vessels react. The test is completed using Laser Doppler Speckle Contrast. We will measure how much the blood vessels dilate. Greater dilation, better vascular function.
Cardiac Function
Time frame: Baseline
An evaluation of cardiac response will be monitored non-invasively. We will use ultrasound to visualize the heart and the blood vessels.
Cardiac MRI (CMR)
Time frame: Baseline
Cardiac MRI will be completed to monitor early signs of poor functionality.
7 secondary outcomes
Spirometry
Time frame: Baseline
Lung Diffusing Capacity
Time frame: Baseline
Complete blood count
Time frame: Baseline
HbA1c
Time frame: Baseline
C-Reactive protein
Time frame: Baseline
Questionnaires
Time frame: Baseline
Arterial Stiffness
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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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.
Paula Rodriguez Miguelez principal investigator
Virginia Commonwealth University
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 Stress, run by Virginia Commonwealth University 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 10 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 14 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vascular function (time frame: Baseline). The study lists 3 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 14 Sep 2026.