MINDS Imaging Ancillary Study

NCT05270356 | Completed DMC

• 2 other identifiers: STUDY21020073R01HL152740
• Study Type: observational
• Target: 195
• Locations: 2 countries
• Sites: 13

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.

Conditions

Adult Congenital Heart Disease

Keywords

Adult Congenital Heart Disease; Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• Brain Injury

  Vascular-related brain injury (cortical infarcts, hemosiderin lesions, and white matter hyperintensity)

  At time of MRI

Interventions

MRI OTHER

Magnet Resonance Imaging of the Brain without Contrast

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Males and Females aged 18 to 30 who have been diagnosed with Congenital Heart Disease

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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Boston Children's Hospital: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (13)

Emory University

Atlanta, Georgia, 30322, United States

Location

Indiana University

Indianapolis, Indiana, 46202-3082, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48103, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84158, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

University Health Network

Toronto, Ontario, ON M5G 2C4, Canada

Location

Related Publications (7)

• Cohen S, Earing MG. Neurocognitive Impairment and Its Long-term Impact on Adults With Congenital Heart Disease. Prog Cardiovasc Dis. 2018 Sep-Oct;61(3-4):287-293. doi: 10.1016/j.pcad.2018.08.002. Epub 2018 Aug 15.

  PMID: 30118722 BACKGROUND

• Daliento L, Mapelli D, Russo G, Scarso P, Limongi F, Iannizzi P, Melendugno A, Mazzotti E, Volpe B. Health related quality of life in adults with repaired tetralogy of Fallot: psychosocial and cognitive outcomes. Heart. 2005 Feb;91(2):213-8. doi: 10.1136/hrt.2003.029280.

  PMID: 15657236 BACKGROUND

• Utens EM, Bieman HJ, Verhulst FC, Meijboom FJ, Erdman RA, Hess J. Psychopathology in young adults with congenital heart disease. Follow-up results. Eur Heart J. 1998 Apr;19(4):647-51. doi: 10.1053/euhj.1997.0824.

  PMID: 9597415 BACKGROUND

• Utens EM, Verhulst FC, Erdman RA, Meijboom FJ, Duivenvoorden HJ, Bos E, Roelandt JR, Hess J. Psychosocial functioning of young adults after surgical correction for congenital heart disease in childhood: a follow-up study. J Psychosom Res. 1994 Oct;38(7):745-58. doi: 10.1016/0022-3999(94)90027-2.

  PMID: 7877129 BACKGROUND

• Ilardi D, Ono KE, McCartney R, Book W, Stringer AY. Neurocognitive functioning in adults with congenital heart disease. Congenit Heart Dis. 2017 Mar;12(2):166-173. doi: 10.1111/chd.12434. Epub 2016 Dec 13.

  PMID: 27957813 BACKGROUND

• Murphy LK, Compas BE, Reeslund KL, Gindville MC, Mah ML, Markham LW, Jordan LC. Cognitive and attentional functioning in adolescents and young adults with Tetralogy of Fallot and d-transposition of the great arteries. Child Neuropsychol. 2017 Jan;23(1):99-110. doi: 10.1080/09297049.2015.1087488. Epub 2015 Sep 20.

  PMID: 26388325 BACKGROUND

• Klouda L, Franklin WJ, Saraf A, Parekh DR, Schwartz DD. Neurocognitive and executive functioning in adult survivors of congenital heart disease. Congenit Heart Dis. 2017 Jan;12(1):91-98. doi: 10.1111/chd.12409. Epub 2016 Sep 21.

  PMID: 27650247 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ashok Panigrahy, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: March 8, 2022
• Study Start: May 27, 2021
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: October 31, 2025

Record last verified: 2024-12

Locations

CA (1); US (12)