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Cardiovascular Health & Early Stress

Cardiovascular Health & Early Stress

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06557707
Enrollment
120
Registered
2024-08-16
Start date
2022-01-20
Completion date
2028-12-31
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress

Brief 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 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.

Interventions

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

Sponsors

Virginia Commonwealth University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
9 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Vascular functionBaselineThis 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 FunctionBaselineAn evaluation of cardiac response will be monitored non-invasively. We will use ultrasound to visualize the heart and the blood vessels.
Cardiac MRI (CMR)BaselineCardiac MRI will be completed to monitor early signs of poor functionality.

Secondary

MeasureTime frameDescription
HbA1cBaselineBlood analysis
C-Reactive proteinBaselineBlood analysis
SpirometryBaselineSubjects 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.
Arterial StiffnessBaselineA 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.
QuestionnairesBaselineLifestyle and stress related questionnaires will be completed by the participants including lifestyle, adversity during childhood, stress risk.
Lung Diffusing CapacityBaselineSubjects 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.
Complete blood countBaselineBlood analysis

Countries

United States

Contacts

Primary ContactPaula Rodriguez Miguelez
prodriguezmig@vcu.edu(804) 396-4498

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026