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Clinical Trials/NCT05258981
NCT05258981
Recruiting
Not Applicable

Exploring the Relationship Between Advanced Multimodal Brain MRI Phenotypes, Genes and Cognitive Outcome in Adults With CHD

Boston Children's Hospital1 site in 1 country225 target enrollmentJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
Boston Children's Hospital
Enrollment
225
Locations
1
Primary Endpoint
Delis-Kaplan Executive Function Scale (D-KEFS) composite score;
Status
Recruiting
Last Updated
2 years ago

Overview

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).

Detailed Description

Aim 1 is structured to determine the relationship between sulcal patterns(measured by MRI) and executive function in adults with d-TGA and if this relationship is modified by (a) presence of neuroresilience gene ApoE ε2 or ε4 alleles, or (b) damaging variants in hypoxia response genes. Aim 2 is designed to determine the relationship between structural connectivity using rich club (measured by MRI) and executive function in adults with d-TGA and if this relationship is modified by (a) presence of neuroresilience gene ApoE ε2 or ε4 alleles or (b) damaging variants in hypoxia response genes. In Aim 3, the investigators will determine the relationship between functional connectivity using rich club (measured by MRI) and executive function in adults with d-TGA and if this relationship is modified by (a) presence of neuroresilience gene ApoE ε2or ε4 alleles or (b) damaging variants in hypoxia response genes.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
June 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michelle Gurvitz

Associate Professor

Boston Children's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Delis-Kaplan Executive Function Scale (D-KEFS) composite score;

Time Frame: Baseline

measure of executive function

Study Sites (1)

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