Clinical trial NCT06557707: Cardiovascular Health & Early Stress
Official title: Cardiovascular Health & Early Stress
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stress
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 120
Sex: ALL
Minimum age (years): 9
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children and young individuals who have been exposed to adversity during childhood

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.

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

Primary outcomes:
measure: Vascular function
timeFrame: Baseline
measure: Cardiac Function
timeFrame: Baseline
measure: Cardiac MRI (CMR)
timeFrame: Baseline
Secondary outcomes:
measure: Spirometry
timeFrame: Baseline
measure: Lung Diffusing Capacity
timeFrame: Baseline
measure: Complete blood count
timeFrame: Baseline
measure: HbA1c
timeFrame: Baseline
measure: C-Reactive protein
timeFrame: Baseline
measure: Questionnaires
timeFrame: Baseline
measure: Arterial Stiffness
timeFrame: Baseline
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Paula Rodriguez Miguelez
role: PRINCIPAL_INVESTIGATOR
References: