The Relationship Between Brain MRI Phenotypes, Genes and Cognitive Outcome in CHD Adults

NCT ID: NCT05258981

Last Updated: 2023-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Congenital Heart Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Brain MRI

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

Group Type OTHER

MRI

Intervention Type DIAGNOSTIC_TEST

Brain MRI

Interventions

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MRI

Brain MRI

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

24 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Michelle Gurvitz

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michelle Gurvitz, MD

Role: CONTACT

617-355-6508

Facility Contacts

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Michelle Gurvitz, MD

Role: primary

617-355-6508

Donna Duva

Role: backup

617-355-5422

Other Identifiers

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P00039087

Identifier Type: -

Identifier Source: org_study_id

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