The Boston Circulatory Arrest Study: Antecedents and Correlates of Well-Being in Adults With Congenital Heart Disease (BCAS-Adult)
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ClinicalTrials.gov Identifier: NCT03073122 |
Recruitment Status :
Active, not recruiting
First Posted : March 8, 2017
Last Update Posted : March 8, 2022
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Condition or disease | Intervention/treatment |
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Transposition Great Arteries Executive Dysfunction | Diagnostic Test: Brain MRI, neurocognitive and psychological testing |
Study Type : | Observational |
Estimated Enrollment : | 122 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The Boston Circulatory Arrest Study: Antecedents and Correlates of Well-Being in Adults With Congenital Heart Disease |
Actual Study Start Date : | November 9, 2017 |
Actual Primary Completion Date : | November 1, 2021 |
Estimated Study Completion Date : | January 31, 2023 |

Group/Cohort | Intervention/treatment |
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TGA Case
Brain MRI, Neurocognitive and psychological testing
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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 |
- Quality of Life health related [ Time Frame: baseline ]Linear analog scale, Quality of Life Survey
- Mental health - Anxiety [ Time Frame: baseline ]Hospital Anxiety and Depression scale and the structured clinical interview for DSM-V
- Mental Health - Depression [ Time Frame: baseline ]Hospital Anxiety and Depression scale and the structured clinical interview for DSM-V
- Mental health - ADHD [ Time Frame: baseline ]structured clinical interview for DSM-V and Connors' Adult ADHD Rating Scales - Screening Version
- Mental health - PTSD [ Time Frame: baseline ]structured clinical interview for DSM-V
- Mental health - Stress [ Time Frame: baseline ]1. The Stress & Self-Efficacy (Perceived Stress; Self-Efficacy) subdomain of the NIH Toolbox Emotion Domain
- Neurocognitive - Executive function [ Time Frame: baseline ]
- 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.
- 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).
- The NIH Toolbox Processing Speed assesses the time it takes to process a set amount of information. It yields a main endpoint score.
- 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.
- Neurocognitive - Risk taking behavior [ Time Frame: baseline ]Iowa Gambling Task (IGT)
- Neurocognitive - social cognition [ Time Frame: baseline ]
- The "Reading the Mind in the Eyes" Task (revised) is a computer-administered task assessing mental state attribution.
- 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.
- 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
- Neurocognitive - memory [ Time Frame: baseline ]
- The NIH Toolbox Picture Sequence Memory Test evaluates episodic memory.
- The Wechsler Memory Scale IV (WMS-IV) provides a comprehensive evaluation of memory abilities in adults, including auditory, visual, immediate, and delayed memory
- mental health - social relatedness [ Time Frame: baseline ]The NIH Toolbox Emotion Domain - The Social Relationships subdomain measures will be administered.
- Employment status [ Time Frame: baseline ]Categories from the National health interview survey and Hollingshead four factor index

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Ages Eligible for Study: | 24 Years to 33 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
Study Group:
Inclusion Criteria
- Prior participation in the Boston Circulatory Arrest Study
- Informed consent
Exclusion Criteria
- Disorders that would prevent successful completion of the planned study testing (severe developmental impairment to prevent answering surveys and participating in interviews)
- 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
- Women who are currently pregnant will be excluded from the MRI portion of the study only
Control Group:
Control Inclusion Criteria
- Age 24-30 years at the time of enrollment
- Informed consent
Control Exclusion Criteria
- Conditions that would prevent successful completion of the planned study testing (MRI) (e.g., pacemaker, metal implants, orthodontia)
- Congenital heart disease requiring surgical correction
- Lack of reading fluency in English, the only language for which questionnaires have been validated
- 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."
- Current pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03073122
United States, Massachusetts | |
Boston Children's Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Michelle Gurvitz, MD | Boston Children's Hospital |
Responsible Party: | Michelle Gurvitz, Assistant Professor, Boston Children's Hospital |
ClinicalTrials.gov Identifier: | NCT03073122 |
Other Study ID Numbers: |
P00023574 1R01HL135061-01 ( U.S. NIH Grant/Contract ) |
First Posted: | March 8, 2017 Key Record Dates |
Last Update Posted: | March 8, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Heart Diseases Heart Defects, Congenital Transposition of Great Vessels |
Cardiovascular Diseases Cardiovascular Abnormalities Congenital Abnormalities |