MINDS Imaging Ancillary Study
- Conditions
- Adult Congenital Heart Disease
- Registration Number
- NCT05270356
- Lead Sponsor
- University of Pittsburgh
- 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" study will recruit 500 complex CHD patients between18-30 years old. The investigators propose to quantitate multi-modal neuroimaging biomarkers (brain injury, structure and physiology) which are not only important components of brain and cognitive reserve but can be predictive of neurocognitive decline and early onset of dementia in the aging non-CHD population.
- 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 CHD (ACHD) patients now outnumber pediatric CHD patients. ACHD patients demonstrate domain-specific neurocognitive deficits such as impairment in executive function, associated with reduced quality of life that includes deficits in educational attainment and social interaction. These deficits are related to risk factors that can occur across the lifespan, including genetic abnormalities, cumulative hypoxic/ischemic injury, and, adult-onset atherosclerotic cerebrovascular disease. The overarching hypothesis is that ACHD patients exhibit vascular brain injury and structural/physiological brain alterations that are predictive of specific neurocognitive deficits, including executive dysfunction, which are modified by behavioral and environmental enrichment proxies of CR (e.g., level of education and lifestyle/social habits). The investigators propose an ancillary study to the NHLBI-funded Pediatric Heart Network (PHN) "Multi-Institutional Neurocognitive Discovery Study (MINDS) in Adult Congenital Heart Disease (ACHD)." The investigators will leverage the MINDS-ACHD parent study data (i.e., NIH Toolbox neuropsychological battery/clinical data/biological samples) and an established neuroimaging harmonization, which the investigators currently use for the PHN Single Ventricle Reconstruction (SVRIII) multi-center brain connectome study (R01-HL128818), to measure neuroimaging biomarkers in ACHD patients at the same PHN sites. The specific aims are: Specific Aim #1 (brain injury): To determine if vascular-related brain injury (cortical infarcts, hemosiderin lesions, and white matter hyperintensity) is associated with specific neurocognitive deficits (e.g. NIH Toolbox total composite score) in ACHD patients. Specific Aim #2 (brain structure): To determine if reduced fronto-temporal cortical thickness and white matter connectivity are associated with specific neurocognitive deficits (e.g. NIH Toolbox frontal executive sub-score) in ACHD patients. Specific Aim #3 (brain physiology): To determine if reduced cerebrovascular reserve (regional cerebral blood flow/ resting BOLD imaging) is associated with specific neurocognitive deficits (e.g. NIH Toolbox crystallized composite score) in ACHD patients. Specific Aim #4 (cognitive reserve): To determine if the associations between neuroimaging biomarkers and neurocognitive outcomes in ACHD patients are modified by behavioral and environmental enrichment proxies of CR, using traditional statistical models and machine learning techniques. Given the paucity of multi-modal neuroimaging studies in ACHD, the proposed study addresses a major knowledge gap in the ACHD population by providing insight into the mechanism underlying impaired neurocognitive outcomes. This study will provide structural-physiological correlates of neurocognitive outcomes, representing the first multi-center neuroimaging study to be performed in ACHD. Importantly, other behavioral and environmental enrichment data will be integrated with these neuroimaging and neurocognitive outcome data to model cognitive reserve. Results from this research will help shape the care of ACHD patients, and further our understanding of the interplay between brain injury and cognitive reserve. The proposed ancillary study is thus both feasible and cost-effective by leveraging the NHLBI-PHN infrastructure. As such, the proposed research is well aligned with the NHLBI's Strategic Vision.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 156
• 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Brain Injury At time of MRI Vascular-related brain injury (cortical infarcts, hemosiderin lesions, and white matter hyperintensity)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
University Health Network
🇨🇦Toronto, Ontario, Canada
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States