Examining brain changes and cognitive function in adults with congenital heart disease
Exploring the Relationship Between Advanced Multimodal Brain MRI Phenotypes, Genes and Cognitive Outcome in Adults With CHD
This study is trying to see how brain changes and genetics affect thinking skills in adults with a specific heart condition called d-TGA compared to people without the condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 225 (estimated) |
| Ages | 24 Years to 35 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05258981 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between brain MRI phenotypes and cognitive outcomes in adults with d-transposition of the great arteries (d-TGA). It aims to analyze sulcal patterns, structural connectivity, and functional connectivity using advanced MRI techniques to understand how these factors relate to executive function. Additionally, the study will explore how genetic variants related to neuroresilience and hypoxia response may influence these relationships. Participants will include individuals who were part of earlier studies at Boston Children's Hospital and age-matched controls.
Who should consider this trial
Good fit: Ideal candidates include adults with d-transposition of the great arteries who participated in previous studies at Boston Children's Hospital.
Not a fit: Patients with significant intellectual impairment or those unable to undergo MRI due to medical or psychological reasons may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could enhance understanding of cognitive outcomes in adults with congenital heart disease, potentially leading to targeted interventions.
How similar studies have performed: While studies have explored cognitive outcomes in congenital heart disease, this specific approach combining MRI phenotypes and genetic factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Michelle Gurvitz, MD
- Email: michelle.gurvitz@cardio.chboston.org
- Phone: 617-355-6508
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.