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

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Brief Title

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

Official Title

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

Brief Summary

      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.
    

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

Observational


Primary Outcome

Quality of Life

Secondary Outcome

 Mental health - Anxiety

Condition

Transposition Great Arteries

Intervention

Brain MRI, neurocognitive and psychological testing

Study Arms / Comparison Groups

 TGA Case
Description:  Brain MRI, Neurocognitive and psychological testing

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

150

Start Date

November 9, 2017

Completion Date

November 30, 2020

Primary Completion Date

June 30, 2020

Eligibility Criteria

        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
      

Gender

All

Ages

24 Years - 30 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Michelle Gurvitz, MD, 617-355-6508, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03073122

Organization ID

P00023574

Secondary IDs

1R01HL135061-01

Responsible Party

Principal Investigator

Study Sponsor

Boston Children's Hospital

Collaborators

 National Heart, Lung, and Blood Institute (NHLBI)

Study Sponsor

Michelle Gurvitz, MD, Principal Investigator, Boston Children's Hospital


Verification Date

August 2019