Capturing Physiologic Autonomic Data from Clinically Indicated Magnetic Resonance Imaging Scans in Children

Completed

• Conditions: Pectus Excavatum; Cardiac Anomaly
• Interventions: Other: VU-AMS device

• Registration Number: NCT06110689
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

The Fontan Procedure is a palliative surgical procedure used in pediatric patients with one functional ventricle. The procedure, a series of stepwise operations that alter cardiorespiratory physiology, separate the systemic and pulmonary circulations to create Fontan physiology, where the systemic venous blood flows passively and without ventricular thrust into the pulmonary circulation. The hallmark of the Fontan circulation is a sustained, abnormally elevated central venous pressure combined with decreased cardiac output, especially during periods of increased demands. Results of several studies in Fontan patients have shown reduced parasympathetic and sympathetic activity compared to controls. In children with congenital heart disease, a differential diagnosis of autonomic dysfunction may be part of their pathophysiology, a compensatory mechanism, a consequence of surgical procedures or a combination of these.

In children, measurement of ANS function is equally important. Children with single ventricle physiology (and other cardiac conditions) have routine surveillance and cardiac magnetic resonance (CMR) imaging to monitor for disease progression. While autonomic data is routinely collected and is available from these scans, these data are rarely, collected and analyzed; however, our group has shown feasibility. Therefore, autonomic data is usually unavailable in children. Despite the availability of agerelated normal values, the predictive power of autonomic activity is understudied in children and there are no published studies of quantification of autonomic data in this population.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-03
• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-25
• Study First Posted: 2023-11-01
• Primary Completion: 2024-11-25
• Study Completion: 2024-11-25
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Ages 0 to ≤ 30 years
• Baseline sinus rhythm (interventricular conduction delays and bundle branch blocks allowed); and undergoing CMR scan in which sequences containing timing of aortic valve opening (cine), vector cardiogram (VCG) and respiratory bellows use will be obtained
• Fontan physiology - only for the Fontan group. Chest wall deformity or arrhythmogenic right ventricular cardiomyopathy for the healthy control group

Exclusion Criteria

• Patient or family refusal;
• Contraindication to study procedures
• Prior participation in the study (ie, we plan to sample without replacement)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fontan	VU-AMS device	Patients undergoing cardiac MRI for Fontan,
Healthy controls	VU-AMS device	Patients undergoing thoracic MRI for chest wall deformity.

Primary Outcome Measures

Name	Time	Method
80% availability of respiratory sinus arrhythmia from cardiac MRI (magnetic resonance imaging)	Through MRI completion up to one hour	Data collected during MRI

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States