Status:
COMPLETED
MINDS Imaging Ancillary Study
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Boston Children's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Adult Congenital Heart Disease
Eligibility:
All Genders
18-30 years
Brief Summary
This study is an ancillary study to the NHLBI-funded Pediatric Heart Network (PHN) "Multi-Institutional Neurocognitive Discovery Study" (MINDS) in Adult Congenital Heart Disease (ACHD). The MINDS-ACHD...
Detailed Description
Dramatic advances in management of congenital heart disease (CHD) have improved survival to adulthood from \<10% in the 1960's to nearly 90% in the current era. With this shifting demographic, adult C...
Eligibility Criteria
Inclusion
- • Participation in and completion of MINDS parent study procedures. The inclusion criteria for the MINDS parent study consists of ACHD patients aged 18 - 30 years with moderate and severely complex CHD.
Exclusion
- Individuals with mild complexity lesions;
- Individuals with MRI contraindications will be excluded from study participation. Contraindications include, but are not limited, to:
- Pregnancy or breast feeding
- Claustrophobia or inability to lie still for an extended period
- Implantable device (i.e., pacemaker; defibrillator; ferromagnetic aneurysm clips; cochlear implant; gastric reflux device; internal insulin pump; pacing leads; neurostimulation system) that cannot be cleared for scanning at 3T
- Foreign body (i.e., metallic splinter in the eye; bullet or grenade fragments)
- Braces or orthodontic appliances that cannot be removed prior to scanning and/or cannot be cleared for scanning at 3T
- Individuals who are unable to participate in the informed consent process or complete the study questionnaire will also be excluded from participation.
Key Trial Info
Start Date :
May 27 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2025
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT05270356
Start Date
May 27 2021
End Date
May 31 2025
Last Update
October 31 2025
Active Locations (13)
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1
Emory University
Atlanta, Georgia, United States, 30322
2
Indiana University
Indianapolis, Indiana, United States, 46202-3082
3
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
4
University of Michigan
Ann Arbor, Michigan, United States, 48103