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Brain MRI Analysis for Congenital Heart Disease

N/A
Recruiting
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Study Summary

This trial will use MRI to study how d-TGA affects the brain, and how genes may play a role in modulating that effect.

Who is the study for?
This trial is for adults with d-transposition of the great arteries who were part of past studies at Boston Children's Hospital, and healthy adults matching their age and sex. Participants must be able to consent to an MRI scan and some cognitive tests. People can't join if they have metal implants, claustrophobia, mental illness history, brain injuries or interventions, intellectual impairments that prevent questionnaire completion, or are not fluent in English.Check my eligibility
What is being tested?
The study uses advanced MRI scans to explore how certain heart defects from birth affect the brain's structure and function related to decision-making skills. It also looks into how genetic differences might influence these changes.See study design
What are the potential side effects?
Since this trial involves only MRI scanning which is a non-invasive imaging technique, there are typically no side effects associated with it. However, individuals may experience discomfort due to lying still during the procedure or from being in a confined space.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a healthy adult who can consent to an MRI and some brain function tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Delis-Kaplan Executive Function Scale (D-KEFS) composite score;

Trial Design

1Treatment groups
Experimental Treatment
Group I: Brain MRIExperimental Treatment1 Intervention
Obtain Brain MRI in adults with congenital heart disease and age/sex matched controls
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI
2009
Completed Phase 2
~1370

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
761 Previous Clinical Trials
5,579,505 Total Patients Enrolled

Media Library

Brain MRI Clinical Trial Eligibility Overview. Trial Name: NCT05258981 — N/A
Congenital Heart Disease Research Study Groups: Brain MRI
Congenital Heart Disease Clinical Trial 2023: Brain MRI Highlights & Side Effects. Trial Name: NCT05258981 — N/A
Brain MRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT05258981 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to partake in this research trial?

"This research study seeks 225 participants with congenital heart disease (CHD) aged between 24 to 35 years old. Most critically, applicants need to have taken part in the Boston Circulatory Arrest, pH and Hematocrit studies at Boston Childrens Hospital as children (n~300). Additionally, normally-developed age-matched adults able to give informed consent must also be included for MRI scans and limited IQ testing alongside more specialized neuropsychological tests which lack a normative reference."

Answered by AI

How many participants are contributing to this trial's findings?

"Affirmative, according to records on clinicaltrials.gov the trial is still enrolling participants. This study was first advertised on July 1st 2022 and last updated 19th September of the same year. The aim is to recruit 225 patients from one medical centre."

Answered by AI

Is the research team currently engaging new participants for this experiment?

"Affirmative. Clinicaltrials.gov points out that the trial, which was launched on July 1st 2022 and recently revised on September 19th 2022, is actively recruiting 225 participants from a single medical site."

Answered by AI

Is there an upper age limit for those eligible to participate in this trial?

"This research aims to include individuals between 24 and 35 years of age."

Answered by AI
~107 spots leftby Jan 2026