Recruiting

Observational Study

Sponsor:

Virginia Commonwealth University

Code:

NCT06557707

Conditions

Stress

Eligibility Criteria

Sex: All

Age: 9 - 30

Healthy Volunteers: Accepted

Interventions

Childhood stress

Study Details

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.

Conditions

Stress

Study ID

NCT06557707

Start date

Jan 20, 2022

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 30

Healthy Volunteers: Accepted

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 Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Young individuals ACE (ages 18-30 years old)

Young individuals who experienced accumulative adverse childhood experiences

Children ACE (ages 9-17 years old)

Children 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.

Interventions

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.

Primary outcome measure

  • Vascular function [ Time Frame: Baseline ]
  • Cardiac Function [ Time Frame: Baseline ]
  • Cardiac MRI (CMR) [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Paula Rodriguez Miguelez

(804) 396-4498prodriguezmig@vcu.edu

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Paula Rodriguez Miguelez

804-396-4498prodriguezmig@vcu.edu

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-09-03.