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Recruiting NCT06557707

Cardiovascular Health & Early Stress

Observational Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Childhood stress.
Who it may be relevant to
Registry conditions: Stress. Basic parameters: 9 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • 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.

Primary outcome measures

  • Vascular function [Time frame: Baseline]
  • Cardiac Function [Time frame: Baseline]
  • Cardiac MRI (CMR) [Time frame: Baseline]
Secondary outcome measures (7)
  • Spirometry [Time frame: Baseline]
  • Lung Diffusing Capacity [Time frame: Baseline]
  • Complete blood count [Time frame: Baseline]
  • HbA1c [Time frame: Baseline]
  • C-Reactive protein [Time frame: Baseline]
  • Questionnaires [Time frame: Baseline]
  • Arterial Stiffness [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Virginia Commonwealth University — Richmond

Identifiers

NCT: NCT06557707 · HM20021768

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗