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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
Be between 18 and 65 years old
Must not have
Intellectual impairment precluding completion of the study questionnaires independently
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot complete study forms by myself due to intellectual impairment.

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
~1620

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
773 Previous Clinical Trials
5,580,726 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
~91 spots leftby Jan 2026
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