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NCT05258981 Clinical Trial

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

Congenital Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05258981
Other study ID # P00039087
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date June 2026

Study information
Verified date August 2023
Source Boston Children's Hospital
Contact Michelle Gurvitz, MD
Phone 617-355-6508
Email michelle.gurvitz@cardio.chboston.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 225
Est. completion date June 2026
Est. primary completion date January 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 24 Years to 35 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• MRI
Brain MRI

Locations
Country Name City State
United States Boston Children's Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Delis-Kaplan Executive Function Scale (D-KEFS) composite score; measure of executive function Baseline
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