Single Ventricle Reconstruction III: Brain Connectome and Neurodevelopmental Outcomes: Design, Recruitment, and Technical Challenges of a Multicenter, Observational Neuroimaging Study

被引：0

作者：

Schmithorst, Vanessa ^{[1
]}

Ceschin, Rafael ^{[1
,2
]}

Lee, Vincent ^{[1
]}

Wallace, Julia ^{[1
]}

Sahel, Aurelia ^{[1
]}

Chenevert, Thomas L. ^{[3
]}

Parmar, Hemant ^{[3
]}

Berman, Jeffrey I. ^{[4
]}

Vossough, Arastoo ^{[4
]}

Qiu, Deqiang ^{[5
]}

Kadom, Nadja ^{[5
]}

Grant, Patricia Ellen ^{[6
]}

Gagoski, Borjan ^{[7
]}

LaViolette, Peter S. ^{[8
]}

Maheshwari, Mohit ^{[8
]}

Sleeper, Lynn A. ^{[9
,10
]}

Bellinger, David C. ^{[11
]}

Ilardi, Dawn ^{[12
]}

O'Neil, Sharon ^{[13
]}

Miller, Thomas A. ^{[14
]}

Detterich, Jon ^{[15
]}

Hill, Kevin D. ^{[16
]}

Atz, Andrew M. ^{[17
]}

Richmond, Marc E. ^{[18
]}

Cnota, James ^{[19
]}

Mahle, William T. ^{[20
]}

Ghanayem, Nancy S. ^{[21
,22
]}

Gaynor, J. William ^{[23
]}

Goldberg, Caren S. ^{[24
]}

Newburger, Jane W. ^{[9
]}

Panigrahy, Ashok ^{[1
]}

机构：

[1] UPMC Childrens Hosp Pittsburgh, Dept Radiol, 4401 Penn Ave,Floor 2, Pittsburgh, PA 15224 USA

[2] Univ Pittsburgh Sch, Dept Biomed Informat, 5607 Baum Blvd, Pittsburgh, PA 15206 USA

[3] Univ Michigan, Michigan Med Dept Radiol, 1500 E Med Ctr Dr, Ann Arbor, MI 48109 USA

[4] Childrens Hosp Philadelphia, Dept Radiol, 3401 Civ Ctr Blvd, Philadelphia, PA 19104 USA

[5] Emory Univ, Dept Radiol & Imaging Sci, Childrens Healthcare Atlanta, 1364 Clifton Rd, Atlanta, GA 30322 USA

[6] Childrens Hosp Boston, Fetal Neonatal Neuroimaging & Dev Sci Ctr FNNDSC, 300 Longwood Ave, Boston, MA 02115 USA

[7] Childrens Hosp Boston, Dept Radiol, 300 Longwood Ave, Boston, MA 02115 USA

[8] Med Coll Wisconsin, Dept Radiol, 9200 W Wisconsin Ave, Milwaukee, WI 53226 USA

[9] Boston Childrens Hosp, Dept Cardiol, 300 Longwood Ave, Boston, MA 02115 USA

[10] Harvard Med Sch, Dept Pediat, 25 Shattuck St, Boston, MA 02115 USA

[11] Boston Childrens Hosp, Dept Neurol, Cardiac Neurodev Program, 300 Longwood Ave, Boston, MA 02115 USA

[12] Childrens Healthcare Atlanta, Dept Neuropsychol, 1400 Tullie Rd NE, Atlanta, GA 30329 USA

[13] Childrens Hosp Los Angeles, Saban Res Inst, Neuropsychol Core, 4661 Sunset Blvd, Los Angeles, CA 90027 USA

[14] Univ Utah, Dept Pediat, Div Pediat Cardiol, Sch Med, 30 N 1900 E, Salt Lake City, UT 84132 USA

[15] Childrens Hosp Los Angeles, Div Pediat Cardiol, 4650 Sunset Blvd, Los Angeles, CA 90027 USA

[16] Duke Univ, Sch Med, Dept Pediat, Div Pediat Cardiol, 7506 Hosp North,DUMC Box 3090, Durham, NC 27710 USA

[17] Med Univ South Carolina, Div Pediat Cardiol, 96 Jonathan Lucas St,Ste 601,MSC 617, Charleston, SC 29425 USA

[18] New York Presbyterian Morgan Stanley Childrens Hos, Program Pediat Cardiomyopathy Heart Failure & Tran, 3959 Broadway MSCH North,2nd Floor, New York, NY 10032 USA

[19] Cincinnati Childrens, Fetal Heart Program, 3333 Burnet Ave, Cincinnati, OH 45229 USA

[20] Childrens Healthcare Atlanta, Div Pediat Cardiol, 1400 Tullie Rd NE,Suite 630, Atlanta, GA 30329 USA

[21] Univ Chicago Med, Comer Childrens Hosp, Dept Pediat, Sect Pediat Crit Care, 5721 S Maryland Ave, Chicago, IL 60637 USA

[22] Med Coll Wisconsin, Dept Pediat, Sect Pediat Crit Care, 9000 W Wisconsin Ave,MS 681, Milwaukee, WI 53226 USA

[23] Childrens Hosp Philadelphia, Heart Failure & Transplant Program, 3401 Civ Ctr Blvd, Philadelphia, PA 19104 USA

[24] CS Mott Childrens Hosp, Dept Pediat, Div Cardiol, 1540 E Hosp Dr 4204, Ann Arbor, MI 48109 USA

来源：

DIAGNOSTICS | 2023年 / 13卷 / 09期

关键词：

hypoplastic left heart syndrome; brain connectome; harmonization; multi-center neuroimaging; phantoms; CONGENITAL HEART-DISEASE; QUALITY-OF-LIFE; FUNCTIONAL CONNECTIVITY; CIRCULATORY ARREST; TEST-RETEST; D-TRANSPOSITION; GREAT-ARTERIES; DIFFUSION MRI; CHILDREN; NETWORK;

D O I：

10.3390/diagnostics13091604

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Patients with hypoplastic left heart syndrome who have been palliated with the Fontan procedure are at risk for adverse neurodevelopmental outcomes, lower quality of life, and reduced employability. We describe the methods (including quality assurance and quality control protocols) and challenges of a multi-center observational ancillary study, SVRIII (Single Ventricle Reconstruction Trial) Brain Connectome. Our original goal was to obtain advanced neuroimaging (Diffusion Tensor Imaging and Resting-BOLD) in 140 SVR III participants and 100 healthy controls for brain connectome analyses. Linear regression and mediation statistical methods will be used to analyze associations of brain connectome measures with neurocognitive measures and clinical risk factors. Initial recruitment challenges occurred that were related to difficulties with: (1) coordinating brain MRI for participants already undergoing extensive testing in the parent study, and (2) recruiting healthy control subjects. The COVID-19 pandemic negatively affected enrollment late in the study. Enrollment challenges were addressed by: (1) adding additional study sites, (2) increasing the frequency of meetings with site coordinators, and (3) developing additional healthy control recruitment strategies, including using research registries and advertising the study to community-based groups. Technical challenges that emerged early in the study were related to the acquisition, harmonization, and transfer of neuroimages. These hurdles were successfully overcome with protocol modifications and frequent site visits that involved human and synthetic phantoms.

引用

页数：21

共 103 条

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