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Clinical Trials/NCT06557707
NCT06557707
Recruiting
Not Applicable

Cardiovascular Health & Early Stress

Virginia Commonwealth University1 site in 1 country120 target enrollmentJanuary 20, 2022
ConditionsStress

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress
Sponsor
Virginia Commonwealth University
Enrollment
120
Locations
1
Primary Endpoint
Cardiac Function
Status
Recruiting
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 20, 2022
End Date
December 1, 2028
Last Updated
8 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Men and pre-menopausal women
  • 18-30 years old
  • males and females
  • 9-17 years old

Exclusion Criteria

  • 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
  • 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

Outcomes

Primary Outcomes

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.

Cardiac MRI (CMR)

Time Frame: Baseline

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

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.

Secondary Outcomes

  • Lung Diffusing Capacity(Baseline)
  • HbA1c(Baseline)
  • Questionnaires(Baseline)
  • Spirometry(Baseline)
  • Arterial Stiffness(Baseline)
  • C-Reactive protein(Baseline)
  • Complete blood count(Baseline)

Study Sites (1)

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