The Boston Circulatory Arrest Study: Antecedents and Correlates of Well-Being in Adults With Congenital Heart Disease (BCAS-Adult)

August 14, 2023 updated by: Michelle Gurvitz, Boston Children's Hospital
In the landmark Boston Circulatory Arrest Study, neurologic and developmental status was measured following infant heart surgery and then prospectively at ages 1, 2.5, 4, 8, and 16 years, with findings of significant neurocognitive deficits and brain MRI abnormalities regardless of operative management. To date, no study has evaluated the neuropsychological and neuroimaging antecedents and correlates of well-being in adults with congenital heart disease, a population now >1 million and projected to grow at 5% per year. The investigators propose to study the Boston cohort at ages 24-29 years to assess the associations of adult well-being with childhood and adolescent executive function, other measures of mental health and cognitive function, adolescent brain MRI findings, and clinical variables; findings will guide the design of interventions in childhood to optimize outcomes in adults with congenital heart disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Previously lethal, critical congenital heart disease (CHD) can now be treated effectively with surgical, catheter, and medical interventions. The resulting dramatic improvement in life expectancy has brought a major demographic shift, so that adult patients with CHD now outnumber children with CHD, even for complex conditions. Adult survivors are at increased risk of anxiety, depression, social difficulties, lower educational attainment, and underemployment. These psychosocial morbidities may be associated with deficits in executive functions (EFs) and other neurocognitive abilities that are prevalent in children and adolescents with CHD. Deficits in EFs, represented by measures of inhibitory control, working memory, cognitive flexibility, and decision-making, are highly dependent on the integrity of cortical and subcortical neural networks that continue to develop into early adulthood and can have a major adverse impact on self-regulation and management. The goal of this proposal is to bridge the gap in knowledge between known executive function deficits in childhood CHD and adult well-being. The investigators propose to accomplish our goal by studying subjects, now age 24-29 years, who were enrolled as infants in the Boston Circulatory Arrest Study and then studied with respect to neuropsychological and developmental function at ages 1, 2.5, 4, 8, and 16 years, as well as with brain MRI at 16 years. In Aim 1, the relationship of EFs to major dimensions of adult well-being will be explored. It is hypothesized that lower performance on EFs will be related to poorer overall well-being. The outcomes measured to determine well-being will be quality of life, neuropsychological function (e.g. social cognition, memory skills), mental health diagnosis and function (e.g. anxiety, depression), social relatedness, academic achievement, and adult independence (e.g. employment status, medical follow up). In Aim 2, the relationship of EFs to MRI-derived measures of brain structure, function, and connectivity will be determined. It is hypothesized that lower performance on EFs will be associated with lower global efficiency (integration) and higher modularity (segregation). The brain MRI outcomes will be measured using global white matter connectivity, regional cortical gray matter thickness, gray matter connectivity measured from interregional correlation in cortical thickness, and functional connectivity as defined by resting state functional magnetic resonance imaging. In Aim 3, longitudinal models will be used to analyze the association of adult well-being with earlier measures of EFs and other neurocognitive and mental health variables, as well as with earlier clinical variables and adolescent neuroimaging. The associations of adult well-being dimensions with childhood and adolescent EFs, other measures of mental health and cognitive function, adolescent brain MRI findings, and clinical variables will be explored. The ultimate goal is to identify early, modifiable risk factors for adult performance to guide the design of targeted treatment strategies that optimize educational achievement, employability, and quality of life in the burgeoning population of adults with CHD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
127

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

24 years to 33 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Study Group: All children enrolled in the original boston circulatory arrest study who are alive and living in the US will be invited to participate. We estimate that about 165 adults will be eligible to participate as we will again attempt to contact those patients who did not participate in the 16 year follow-up.

Controls (for MRI): A group of 50 normally-developed age- and sex-matched young adults ages 24-30 years old who are able to provide informed consent to undergo the MRI portion of the study and limited neuropsychiatric (NP) evaluation. These controls will be recruited from the local metro-Boston area and we will frequency-match control patients to study patients by gender, integer age and handedness.

Description

Study Group:

Inclusion Criteria

  1. Prior participation in the Boston Circulatory Arrest Study
  2. Informed consent

Exclusion Criteria

  1. Disorders that would prevent successful completion of the planned study testing (severe developmental impairment to prevent answering surveys and participating in interviews)
  2. Participants lack of reading fluency in English, which is the only language for which we have the ability to do neuropsychology testing, and for which questionnaires have been validated
  3. Women who are currently pregnant will be excluded from the MRI portion of the study only

Control Group:

Control Inclusion Criteria

  1. Age 24-30 years at the time of enrollment
  2. Informed consent

Control Exclusion Criteria

  1. Conditions that would prevent successful completion of the planned study testing (MRI) (e.g., pacemaker, metal implants, orthodontia)
  2. Congenital heart disease requiring surgical correction
  3. Lack of reading fluency in English, the only language for which questionnaires have been validated
  4. Because we purposefully wish to compare d-TGA patients with those in optimal neurodevelopmental health, we will use the exclusion criteria for the NIH-funded project, "MRI study of normal brain development."
  5. Current pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
TGA Case
Brain MRI, Neurocognitive and psychological testing
Diagnostic test: Brain MRI, neurocognitive and psychological testing
MRI of the brain and multiple tests of neurocognitive and psychological function including executive function, anxiety and depression
Control
Brain MRI, Neurocognitive and psychological testing
Diagnostic test: Brain MRI, neurocognitive and psychological testing
MRI of the brain and multiple tests of neurocognitive and psychological function including executive function, anxiety and depression

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quality of Life health related
Time Frame: baseline
Linear analog scale, Quality of Life Survey
baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mental health - Anxiety
Time Frame: baseline
Hospital Anxiety and Depression scale and the structured clinical interview for DSM-V
baseline
Mental Health - Depression
Time Frame: baseline
Hospital Anxiety and Depression scale and the structured clinical interview for DSM-V
baseline
Mental health - ADHD
Time Frame: baseline
structured clinical interview for DSM-V and Connors' Adult ADHD Rating Scales - Screening Version
baseline
Mental health - PTSD
Time Frame: baseline
structured clinical interview for DSM-V
baseline
Mental health - Stress
Time Frame: baseline
1. The Stress & Self-Efficacy (Perceived Stress; Self-Efficacy) subdomain of the NIH Toolbox Emotion Domain
baseline
Neurocognitive - Executive function
Time Frame: baseline
  1. The Delis-Kaplan Executive Function System (D-KEFS) includes nine subtests: Trail-Making, Verbal Fluency, Design Fluency, Color-Word Interference, Card Sorting, Twenty Questions, Word Context, Tower, and Proverb.
  2. The NIH Toolbox Assessment of Neurological and Behavioral Function, executive function battery is a set of computerized assessments that measure: (a) Inhibitory control (Flanker Inhibitory Control and Attention Test); (b) Working Memory (List Sorting Working Memory Test); (c) Cognitive Flexibility (Dimensional Change Card Sort Test).
  3. The NIH Toolbox Processing Speed assesses the time it takes to process a set amount of information. It yields a main endpoint score.
  4. The Behavior Rating Inventory of Executive Function for Adults (BRIEF-A) includes 75 items that yield 9 clinical scales grouped into two indexes: Behavioral Regulation and Metacognition.
baseline
Neurocognitive - Risk taking behavior
Time Frame: baseline
Iowa Gambling Task (IGT)
baseline
Neurocognitive - social cognition
Time Frame: baseline
  1. The "Reading the Mind in the Eyes" Task (revised) is a computer-administered task assessing mental state attribution.
  2. The Advanced Clinical Solutions for WAIS-IV and WMS IV (ACS) is a set of tasks that assess aspects of social cognition, such as affect labeling, affect recognition from faces and prosody, identification of sarcasm, and the ability to verbalize intent of a speaker.
  3. The Autism Spectrum Quotient is a self-report questionnaire covering five domains of autism spectrum disorder: social skills, communication skills, imagination, attention to detail, and attention switching/tolerance of change
baseline
Neurocognitive - memory
Time Frame: baseline
  1. The NIH Toolbox Picture Sequence Memory Test evaluates episodic memory.
  2. The Wechsler Memory Scale IV (WMS-IV) provides a comprehensive evaluation of memory abilities in adults, including auditory, visual, immediate, and delayed memory
baseline
mental health - social relatedness
Time Frame: baseline
The NIH Toolbox Emotion Domain - The Social Relationships subdomain measures will be administered.
baseline
Employment status
Time Frame: baseline
Categories from the National health interview survey and Hollingshead four factor index
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Children's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michelle Gurvitz, MD, Boston Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P00023574
  • 1R01HL135061-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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