Trial DesignsDesign of a multi-institutional neurocognitive discovery study in adult congenital heart disease (MINDS-ACHD)
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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2024, Journal of the American College of CardiologyDesign and Harmonization Approach for the Multi-Institutional Neurocognitive Discovery Study (MINDS) of Adult Congenital Heart Disease (ACHD) Neuroimaging Ancillary Study: A Technical Note
2023, Journal of Cardiovascular Development and Disease
ClinicalTrials.gov identifier: NCT05270356.