SVR III: Brain Connectome and Neurodevelopmental Outcomes

NCT02692443 | Completed DMC

• 1 other identifier: R01HL128818
• Study Type: observational
• Target: 223
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with hypoplastic left heart syndrome and other single right ventricle lesions who have undergone the Fontan procedure have a high risk of neurodevelopmental disorders that affect quality of life and adulthood employment. This study will leverage the ongoing National Heart, Lung, and Blood Institute (NHLBI)-funded Single Ventricle Reconstruction Study by using innovative graph measures of brain connectivity to elucidate how alterations of the "connectome" in children with critical congenital heart disease are associated with developmental disabilities and their associated clinical risk factors. Improved understanding of these interrelationships may facilitate development of targeted interventions to improve outcome in the soaring population of adult Fontan survivors.

Conditions

Congenital Heart Disease

Keywords

Congenital Heart Disease; Magnetic Brain Resonance; CHD; MRI; Neurodevelopmental

Outcome Measures

Primary Outcomes (1)

• MRI and neurodevelopmental outcomes in CHD patients as compared to their healthy counterparts

  To precisely characterize the specific relationships between global brain network topology, specific patient/medical factors, and adverse neurocognitive/behavioral outcomes in the SVRIII cohort.

  Through study completion, an average of 4 years

Study Arms (2)

SVR Survivors

Through the SVR and SVR II studies vital status has been followed annually for the entire SVR cohort. As of June 2014 352 subjects are alive, 18 of whom have undergone cardiac transplantation, and 18 have undergone biventricular conversion leaving 334 transplant-free survivors with single ventricle physiology. Each patient enrolled to this ancillary study from the parent SVR study will be asked to undergo Magnetic Resonance Imaging (Brain MRI without Contrast) in addition to the already scheduled parent study follow-up procedures.

Device: Magnetic Resonance Imaging; Behavioral: Neurodevelopmental Testing

Healthy Controls

In addition to the SVR survivors, investigators plan to enroll 100 age- and gender-matched healthy controls. Healthy controls enrolled for participation in this ancillary study will be asked to undergo Magnetic Resonance Imaging (Brain MRI without Contrast) in addition to completing the Neurodevelopmental Testing Battery that is already part of the parent SVR study and completed by SVR Survivors as part of their SVR follow-up appointments.

Device: Magnetic Resonance Imaging; Behavioral: Neurodevelopmental Testing

Interventions

Magnetic Resonance Imaging DEVICE

Brain MRI without Contrast

Healthy Controls; SVR Survivors

Neurodevelopmental Testing BEHAVIORAL

Validated battery of neurodevelopmental and psychological tests.

Healthy Controls; SVR Survivors

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

SVR Survivor - male and female - 10 to 12 years of age

You may qualify if:

• SVR Survivor:
• All SVR study cohort members will be contacted to assess for vital status
• Transplant free survivors will be approached to participate in the in-person assessment
• Healthy Controls: Males and females aged 10 - 12 at the time of enrollment and whose parent or legal guardian can provide consent for participation will be recruited for participation in this study. Study participants will also be asked to provide assent for participation in this study.

You may not qualify if:

• SVR Survivors: The investigators will exclude patients who have undergone cardiac transplantation or biventricular conversion from all outcomes other than vital status.
• Those patients with a contraindication to MRI (i.e., claustrophobia; metal screen failure; inability to lie still) will not be enrolled for participation in this study.
• Healthy Controls: Potential participants will be excluded for any of the following reasons:
• disorders that would prevent successful completion of the planned study testing (e.g., pacemaker, metal implants; claustrophobia; inability to lie still)
• other forms of congenital heart disease requiring surgical correction
• Lack of reading fluency in English by primary caregiver in English

Sponsors & Collaborators

• University of Pittsburgh: lead
• Boston Children's Hospital: collaborator
• Children's Hospital of Philadelphia: collaborator
• Emory University: collaborator
• Medical College of Wisconsin: collaborator
• University of Michigan: collaborator

Related Publications (1)

• Schmithorst V, Ceschin R, Lee V, Wallace J, Sahel A, Chenevert T, Parmar H, Berman JI, Vossough A, Qiu D, Kadom N, Grant PE, Gagoski B, LaViolette P, Maheshwari M, Sleeper LA, Bellinger D, Ilardi D, O'Neil S, Miller TA, Detterich J, Hill KD, Atz AM, Richmond M, Cnota J, Mahle WT, Ghanayem N, Gaynor W, Goldberg CS, Newburger JW, Panigrahy A. Single Ventricle Reconstruction III: Brain Connectome and Neurodevelopmental Outcomes: Design, Recruitment, and Technical Challenges of a Multicenter, Observational Neuroimaging Study. medRxiv [Preprint]. 2023 Apr 17:2023.04.12.23288433. doi: 10.1101/2023.04.12.23288433.

  PMID: 37131744 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology

Study Record Dates

• First Submitted: September 24, 2015
• First Posted: February 26, 2016
• Study Start: August 1, 2015
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After all study subjects have completed participation and analysis have been completed.
• Access Criteria: Data will be shared through secure website with interested research and accessible only by username and password provided by PI research team.