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.

Study Overview

• Status: Recruiting
• Conditions: Stress
• Intervention / Treatment: Other: Childhood stress

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Paula Rodriguez Miguelez; Phone Number: (804) 396-4498; Email: prodriguezmig@vcu.edu

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Virginia Commonwealth University
      • Contact: Paula Rodriguez Miguelez; Phone Number: 804-396-4498; Email: prodriguezmig@vcu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Children and young individuals who have been exposed to adversity during childhood

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Young individuals ACE (ages 18-30 years old); Young individuals who experienced accumulative adverse childhood experiences	Other: Childhood stress; Based on stress-related information, participants will be divided into those who were exposed to adversity during childhood and those who were not exposed.
Children ACE (ages 9-17 years old); Children who experienced accumulative adverse childhood experiences .	Other: Childhood stress; Based on stress-related information, participants will be divided into those who were exposed to adversity during childhood and those who were not exposed.
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline
Cardiac MRI (CMR)	Cardiac MRI will be completed to monitor early signs of poor functionality.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline
Complete blood count	Blood analysis	Baseline
HbA1c	Blood analysis	Baseline
C-Reactive protein	Blood analysis	Baseline
Questionnaires	Lifestyle and stress related questionnaires will be completed by the participants including lifestyle, adversity during childhood, stress risk.	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.	Baseline

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Paula Rodriguez Miguelez, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HM20021768

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No