The Relationship Between Brain MRI Phenotypes, Genes and Cognitive Outcome in CHD Adults
Primary Purpose
Congenital Heart Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional other trial for Congenital Heart Disease
Eligibility 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
Sites / Locations
- Boston Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Brain MRI
Arm Description
Obtain Brain MRI in adults with congenital heart disease and age/sex matched controls
Outcomes
Primary Outcome Measures
Delis-Kaplan Executive Function Scale (D-KEFS) composite score;
measure of executive function
Secondary Outcome Measures
Full Information
NCT ID
NCT05258981
First Posted
February 8, 2022
Last Updated
August 14, 2023
Sponsor
Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05258981
Brief Title
The Relationship Between Brain MRI Phenotypes, Genes and Cognitive Outcome in CHD Adults
Official Title
Exploring the Relationship Between Advanced Multimodal Brain MRI Phenotypes, Genes and Cognitive Outcome in Adults With CHD
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
225 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Brain MRI
Arm Type
Other
Arm Description
Obtain Brain MRI in adults with congenital heart disease and age/sex matched controls
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI
Intervention Description
Brain MRI
Primary Outcome Measure Information:
Title
Delis-Kaplan Executive Function Scale (D-KEFS) composite score;
Description
measure of executive function
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Gurvitz, MD
Phone
617-355-6508
Email
michelle.gurvitz@cardio.chboston.org
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Gurvitz, MD
Phone
617-355-6508
Email
michelle.gurvitz@cardio.chboston.org
First Name & Middle Initial & Last Name & Degree
Donna Duva
Phone
617-355-5422
Email
donna.duva@cardio.chboston.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified participant data will be shared with other researchers upon request and approval of the PI.
IPD Sharing Time Frame
The data will become available 5 years after study completion
IPD Sharing Access Criteria
Researchers will need to request the data and have approval of the study PI
Learn more about this trial
The Relationship Between Brain MRI Phenotypes, Genes and Cognitive Outcome in CHD Adults
We'll reach out to this number within 24 hrs