Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT05258981

Conditions

Congenital Heart Disease

Eligibility Criteria

Sex: All

Age: 24 - 35

Healthy Volunteers: Accepted

Interventions

MRI

Study Details

Brief summary:

The main purpose of this proposal is to perform novel MRI analyses to determine the brain organizational changes associated with altered executive function and the modulating role of variants in neuroresilience and hypoxia response genes in adults with d-transposition of the great arteries (d-TGA).

Conditions

Congenital Heart Disease

Study ID

NCT05258981

Start date

Jul 1, 2022

Status verified date

Aug, 2023

Completion date

Jun, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 24 - 35

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Persons who participated in the Boston circulatory arrest, pH and Hematocrit studies at Boston Childrens Hospital as children (n\~300).
  • Normally-developed age- and sex-matched young adults who are able to provide informed consent to undergo the MRI portion of the study and limited neuropsychological evaluation (IQ assessment as well as neuropsychological tests for which normative references are not available).

Exclusion Criteria:

  • For controls - inability to complete the MRI (implanted metal, claustrophobia, personal history of mental illness, brain injury, prior brain intervention).
  • Intellectual impairment precluding completion of the study questionnaires independently
  • Unable to speak and read English fluently

Study Design

Enrollment

225 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Brain MRI

Obtain Brain MRI in adults with congenital heart disease and age/sex matched controls

Interventions

MRI

Brain MRI

Primary outcome measure

  • Delis-Kaplan Executive Function Scale (D-KEFS) composite score; [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Michelle Gurvitz, MD

617-355-6508michelle.gurvitz@cardio.chboston.org

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Michelle Gurvitz, MD

617-355-6508michelle.gurvitz@cardio.chboston.org

Donna Duva

617-355-5422donna.duva@cardio.chboston.org

More Information

Sponsor

Boston Children's Hospital

Last update posted

Aug 15, 2023

Last verified

Aug, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2023-08-15.