Elsevier

American Heart Journal

Volume 262, August 2023, Pages 131-139
American Heart Journal

Trial Designs
Design of a multi-institutional neurocognitive discovery study in adult congenital heart disease (MINDS-ACHD)

https://doi.org/10.1016/j.ahj.2023.04.002Get rights and content

Background

Neurocognitive dysfunction (NCD) is a common comorbidity among children with congenital heart disease (CHD). However, it is unclear how underlying CHD and its sequelae combine with genetics and acquired cardiovascular and neurological disease to impact NCD and outcomes across the lifespan in adults with CHD.

Methods

The Multi-Institutional Neurocognitive Discovery Study in Adults with Congenital Heart Disease (MINDS-ACHD) is a partnership between the Pediatric Heart Network (PHN) and the Adult Alliance for Research in Congenital Cardiology (AARCC) that examines objective and subjective neurocognitive function and genetics in young ACHD. This multicenter cross-sectional pilot study is enrolling 500 young adults between 18 and 30 years with moderate or severe complexity CHD at 14 centers in North America. Enrollment includes 4 groups (125 participants each): (1) d-looped Transposition of the Great Arteries (d-TGA); (2) Tetralogy of Fallot (TOF); (3) single ventricle (SV) physiology; and (4) “other moderately or severely complex CHD.” Participants complete the standardized tests from the NIH Toolbox Cognitive Battery, the NeuroQoL, the Hospital Anxiety and Depression Scale, and the PROMIS Global QoL measure. Clinical and demographic variables are collected by interview and medical record review, and an optional biospecimen is collected for genetic analysis. Due to the COVID-19 pandemic, participation may be done remotely. Tests are reviewed by a Neurocognitive Core Laboratory.

Conclusions

MINDS-ACHD is the largest study to date characterizing NCD in young adults with moderate or severely complex CHD in North America. Its results will provide valuable data to inform screening and management strategies for NCD in ACHD and improve lifelong care.

Section snippets

Methods

MINDS-ACHD is funded by the National Heart, Lung, and Blood Institute's (NHLBI) Pediatric Heart Network (PHN) and is executed in collaboration with The Alliance for Adult Research in Congenital Cardiology (AARCC).

Enrolled participants are aged 18 to 30 years, with moderate or severe complexity CHD, as defined by the 2018 American College of Cardiology/American Heart Association ACHD Guidelines.2 Participants are excluded if they have nonstructural CHD (eg, connective tissue disease, genetic

Discussion

MINDS-ACHD provides a framework to describe NCD in ACHD and inform targeted treatment strategies to improve outcomes. This analysis adds to the literature on childhood NCD in CHD by providing data on adult populations with d-TGA, TOF, and SV,19 and the group with “other moderately and severely complex CHD” provides exploratory data on less-well-studied lesions. Understanding the true burden of NCD in the ACHD population will enable a shift from description towards intervention.

It is well known

Submission declaration

This work has been approved by all authors. It has not been published previously and is not in consideration for publication elsewhere. If accepted for publication, this work will not be submitted for publication elsewhere in the same form, in English or any other language, including electronically without the written consent of the copyright holder.

Ethics and dissemination

Institutional Review Board (IRB) approval was obtained at each participating site using a single IRB model for centers in the United States, and Ethics Board approval was obtained at the Canadian site. Additional oversight is provided by an NIH-appointed Data and Safety Monitoring Board and an independent medical monitor. Written consent is obtained from each participant.

Funding

Funding for this study is provided by grants from the National Heart, Lung, and Blood Institute (HL135646, HL135665, HL135666, HL135678, HL135680, HL135682, HL135683, HL135685, HL135689, and HL135691).

CRediT authorship contribution statement

Scott Cohen: Conceptualization, Methodology, Investigation, Writing – original draft, Supervision, Funding acquisition. Michelle Gurvitz: Conceptualization, Methodology, Investigation, Writing – original draft, Supervision, Funding acquisition. Kristin M. Burns: Conceptualization, Methodology, Investigation, Writing – original draft, Supervision. Olivia Wheaton: Data curation, Supervision, Project administration, Writing – review & editing. Ashok Panigrahy: Methodology, Writing – review &

Conflicts of interest

There are no declarations of interest to disclose for any of the authors. The views expressed in this manuscript are those of the authors and do not reflect official positions of the National Heart, Lung, and Blood Institute, the National Institutes of Health (NIH), or the United States Department of Health and Human Services.

Acknowledgments

None

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