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NCT Number: NCT06557707

Cardiovascular Health & Early Stress

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.

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Key information

Conditions

Age range

9 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location status: Recruiting

Location contact

Paula Rodriguez Miguelez

CONTACT

[email protected]

804-396-4498

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Cohort 1

  • Men and pre-menopausal women
  • 18-30 years old

Cohort 2

  • males and females
  • 9-17 years old

Exclusion criteria

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

  • 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

Treatment and study plan

Childhood stress

Other

Based on stress-related information, participants will be divided into those who were exposed to adversity during childhood and those who were not exposed.

Primary outcomes

  1. 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.

  2. 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.

  3. Cardiac MRI (CMR)

    Time frame: Baseline

    Cardiac MRI will be completed to monitor early signs of poor functionality.

Secondary outcomes

  1. Spirometry

    Time frame: Baseline

    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.

  2. Lung Diffusing Capacity

    Time frame: Baseline

    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.

  3. Complete blood count

    Time frame: Baseline

    Blood analysis

  4. HbA1c

    Time frame: Baseline

    Blood analysis

  5. C-Reactive protein

    Time frame: Baseline

    Blood analysis

  6. Questionnaires

    Time frame: Baseline

    Lifestyle and stress related questionnaires will be completed by the participants including lifestyle, adversity during childhood, stress risk.

  7. Arterial Stiffness

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Paula Rodriguez Miguelez

CONTACT

[email protected]

(804) 396-4498

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Aug 16, 2024
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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