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

NCT05258981 | Recruiting

• 1 other identifier: P00039087
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  measure of executive function

  Baseline

Study Arms (1)

Brain MRI

OTHER

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

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

Brain MRI

Brain MRI

Eligibility Criteria

• Age: 24 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Michelle Gurvitz, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 28, 2022
• Study Start: July 1, 2022
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will become available 5 years after study completion
• Access Criteria: Researchers will need to request the data and have approval of the study PI

Locations

US (1)