Association of Mood With Risk for Atherosclerosis

Hypertension Clinical Trial

— AuRA  

Official title:

AuRA Study: Association of Mood With Risk for Atherosclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04298944
• Other study ID #: IRB00226838
• Secondary ID: P50MH115842-01
• Status: Completed
• Start date: March 11, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: August 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The investigators will aim to determine the association of mood disorders (MDO) with preclinical and clinical cardiovascular (CVD) risk factors among children.

The investigators will also aim to identify traditional and non traditional predictors of CVD risk among children with MDO.

Description:

This research is being done to determine if mood disorders in children have an impact on stiffness of arteries and/or cause the arteries to not work as well and if MDOs impact blood pressure over a 24 hour period of time.The investigators also want to determine if children with mood disorders have any risk factors or blood tests that can predict how stiff arteries are or how well arteries function and if these are associated with cardiovascular disease risk. The investigators also want to determine if children with mood disorders have greater adverse childhood experiences, worse emotional regulation and poorer quality of sleep. The investigators hope that information from this study could help in earlier detection of cardiovascular disease risk in children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Gender: All
• Age group: N/A to 22 Years

Eligibility

Inclusion Criteria:

• Children Ages = 22 years old

• Enrolled in the CHAMPION Trial and have agreed to be contacted for future studies or children who visit PMP clinic and have MDO and a healthy weight or participants in the Be-HealthY Cohort whose data indicate no history of MDO.

Exclusion Criteria:

• Not able to speak English

• Unable to lie supine

• Significant Arrhythmia

• If participant has used vaso-active drugs the morning of the test (tobacco, caffeine decongestants, or asthma medications).

Related Conditions & MeSH terms

• Atherosclerosis
• Elevated Blood Pressure
• Hypertension
• Mood Disorders
• Overweight
• Overweight and Obesity
• Sleep
• Vascular Stiffness

Intervention

Diagnostic Test:
• Cardiovascular Assessments
Participants will undergo the following cardiovascular assessments: 24-hour blood pressure monitoring, arterial stiffness measurements, endothelial function measurements.
• Actigraphy
Participants will wear an actigraph device for 7 days to measure participant's activity and sleep
• Laboratory assessments
Participants will provide blood and urine samples for laboratory assessments.

Behavioral:
• Emotional/ Behavioural assessments
Emotional /Behavioral well being will be determined by questionnaires: Pediatrics Adverse Childhood Experiences Questionnaire (ACEs Q), Childrens Emotion Management Scale Questionnaire (CEMS) and Behavior Assessment System for Children (BASC)

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine Division of Pediatric Nephrology	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial stiffness as assessed by Pulse wave velocity	This will be determined from Pulse wave velocity (m/sec) done at the study visit	1 day
Primary	Arterial stiffness as assessed by Ambulatory Arterial Stiffness Index (AASI)	The Ambulatory Arterial Stiffness Index will be determined from data obtained from vascular measures and during 24-hour ambulatory blood pressure monitoring. Arterial stiffness increases as the regression slope approaches 0 and the AASI approaches 1.	1 day
Primary	Arterial stiffness as assessed by Augmentation Index	The Augmentation Index (measured as a percentage) will be determined from a vascular assessment and data obtained during 24-hour ambulatory blood pressure monitoring. A greater Augmentation Index represents a stiffer, less compliant vessel.	1 day
Primary	Endothelial function as assessed by Laser Doppler flow perfusion	The percent change in mean blood flow will be determined from Laser Doppler flow perfusion measurements obtained using a heating protocol.	1 day
Primary	Mean Blood pressure (mmHg)	Mean daytime systolic blood pressure in millimeters of mercury (mmHg) will be determined from 24-hour blood pressure monitoring.	1 day
Secondary	Pediatric Adverse Childhood Events (ACEs) score	The Pediatric ACEs questionnaire contains 17 yes or no questions about stressful or traumatic life events. Greater exposure to adverse childhood experiences (ACEs) is associated with poorer physical and mental health. Some researchers have suggested that an ACEs score of greater than or equal to 3 or 4 significantly increases the risk for health problems, however, there is no widely accepted threshold for how many ACEs endorsed is clinically significant or more predictive of these problems.	1 day
Secondary	Children's Emotion Management Scale (CEMS) score	The Children's Emotional management scale is a questionnaire that consists of 33 questions (3 point Likert scale) examining youth's ability to regulate appropriately the youth's negative emotions (i.e. anger, sadness, and worry). Generally, poorer emotion regulation capabilities are associated with poorer health outcomes, with most research looking at CV outcomes in adults.	1 day
Secondary	Behavior Assessment for Children (BASC) score	The Behavior Assessment for Children is a questionnaire that consists of 189 questions (True/False and 4 point Likert scale). It is a broad behavioral screening measure commonly used in child and adolescent psychology and psychiatric settings.It has three primary scales: internalizing (e.g., depression, anxiety), externalizing (e.g., aggression, hyperactivity), and total problems (combination of internalizing and externalizing plus attention problems and withdrawal subscales). Scores between 60-69 are considered "at risk" for clinical problems and scores of 70+ are considered clinically significant presence of those symptoms. Any scores that are not in this range are considered to be within normal limits and not indicative of difficulties.	1 day