MINDS Imaging Ancillary Study

Completed

Conditions studied: Adult Congenital Heart Disease

In brief

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.

Key facts

Study ID

NCT05270356

Run by

University of Pittsburgh

People needed

195

Starts

2021-05-27

Expected to finish

2025-05-31

Last updated by the study team

2025-10-31

Who can join

Age: 18 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Emory University — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• University Health Network — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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