Association of Mood With Risk for Atherosclerosis
AuRA
AuRA Study: Association of Mood With Risk for Atherosclerosis
2 other identifiers
observational
37
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2020
CompletedFirst Posted
Study publicly available on registry
March 6, 2020
CompletedStudy Start
First participant enrolled
March 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedAugust 23, 2022
August 1, 2022
2.2 years
March 4, 2020
August 22, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
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
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
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
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
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 Outcomes (3)
Pediatric Adverse Childhood Events (ACEs) score
1 day
Children's Emotion Management Scale (CEMS) score
1 day
Behavior Assessment for Children (BASC) score
1 day
Study Arms (3)
BeHealthY Cohort
Children from BeHealthY cohort who are obese/overweight but do not have mood disorders are eligible for this study. The children will be given additional questionnaires to assess emotional/behavioral well being.
CHAMPION trial Cohort
Children who are overweight/obese and have severe mental illness, and who have agreed to be contacted for future research. Tests will be done on all participants which includes cardiovascular assessments, actigraphy, laboratory assessments and emotional/behavioral assessments.
Pediatric Medical Psychiatric (PMP) Clinic Cohort
Children from the PMP Clinic who have severe mental illness but healthy weight. Tests will be done on all participants which includes cardiovascular assessments, actigraphy, laboratory assessments and emotional/behavioral assessments.
Interventions
Participants will undergo the following cardiovascular assessments: 24-hour blood pressure monitoring, arterial stiffness measurements, endothelial function measurements.
Participants will wear an actigraph device for 7 days to measure participant's activity and sleep
Participants will provide blood and urine samples for laboratory 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)
Eligibility Criteria
Children and young adults up to 22 years of age who belong to either of the following groups: 1. overweight/obese and no history of mood disorders 2. overweight/obese with a mood disorder 3. not overweight/obese with a mood disorder
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins School of Medicine Division of Pediatric Nephrology
Baltimore, Maryland, 21287, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tammy M Brady, M.D, PhD
Johns Hopkins University
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 7 Days
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2020
First Posted
March 6, 2020
Study Start
March 11, 2020
Primary Completion
May 31, 2022
Study Completion
May 31, 2022
Last Updated
August 23, 2022
Record last verified: 2022-08