Cardiovascular Health & Early Stress

NCT06557707 | Recruiting DMC FDA Drug

• 1 other identifier: HM20021768
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Spirometry

  Baseline

• Lung Diffusing Capacity

  Baseline

• Complete blood count

  Baseline

• HbA1c

  Baseline

• C-Reactive protein

  Baseline

Study Arms (4)

Young individuals ACE (ages 18-30 years old)

Young individuals who experienced accumulative adverse childhood experiences

Other: Childhood stress

Children ACE (ages 9-17 years old)

Children who experienced accumulative adverse childhood experiences .

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.

Interventions

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.

Children ACE (ages 9-17 years old); Young individuals ACE (ages 18-30 years old)

Eligibility Criteria

• Age: 9 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Cohort 1
• Men and pre-menopausal women
• years old
• Cohort 2
• males and females
• years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood is collected for routinary biomarkers and exploratory biomarkers

Study Officials

• Paula Rodriguez Miguelez

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paula Rodriguez Miguelez

CONTACT

(804) 396-4498; prodriguezmig@vcu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: August 16, 2024
• Study Start: January 20, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

US (1)