- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03073122
The Boston Circulatory Arrest Study: Antecedents and Correlates of Well-Being in Adults With Congenital Heart Disease (BCAS-Adult)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Boston Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
TGA Case
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
|
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
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
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
|
|
baseline
|
Neurocognitive - Risk taking behavior
Time Frame: baseline
|
Iowa Gambling Task (IGT)
|
baseline
|
Neurocognitive - social cognition
Time Frame: baseline
|
|
baseline
|
Neurocognitive - memory
Time Frame: baseline
|
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Michelle Gurvitz, MD, Boston Children's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P00023574
- 1R01HL135061-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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