Cardiovascular Health & Early Stress

NCT ID: NCT06557707

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-20

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Stress

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Young individuals ACE (ages 18-30 years old)

Young individuals who experienced accumulative adverse childhood experiences

Childhood stress

Intervention Type 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)

Children who experienced accumulative adverse childhood experiences .

Childhood stress

Intervention Type 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.

Young individuals No ACE (ages 18-30 years old)

Young individuals who have not experienced accumulative adverse childhood experiences

No interventions assigned to this group

Children No ACE (ages 9-17 years old)

Children who have not experienced accumulative adverse childhood experiences.

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paula Rodriguez Miguelez

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Paula Rodriguez Miguelez

Role: CONTACT

(804) 396-4498

Facility Contacts

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Paula Rodriguez Miguelez

Role: primary

804-396-4498

Other Identifiers

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HM20021768

Identifier Type: -

Identifier Source: org_study_id

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