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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Anomaly; Pectus Excavatum
• Intervention / Treatment: Other: VU-AMS device

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting for clinically indicated CMR scans with planned cine sequence and use of a respiratory bellows.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fontan; Patients undergoing cardiac MRI for Fontan,	Other: VU-AMS device; Patients will wear the VU-AMS monitor prior to MRI.
Healthy controls; Patients undergoing thoracic MRI for chest wall deformity.	Other: VU-AMS device; Patients will wear the VU-AMS monitor prior to MRI.

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare estimate of pre-ejection period (PEP)	Collection of data from VU-AMS monitor	Prior to MRI scan up to 10 minutes
Compare estimate of pre-ejection period (PEP)	Collection of data from the cardiac MRI	Through MRI completion up to one hour
Describe difference in respiratory sinus arrhythmia in participants with Fontan	Collection of data from the cardiac MRI	Through MRI completion up to one hour
Describe difference in respiratory sinus arrhythmia in participants with pectus	Collection of data from the cardiac MRI	Through MRI completion up to one hour

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Pornswan Ngamprasertwong, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Actual): November 25, 2024
• Study Completion (Actual): November 25, 2024

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Cardiovascular Diseases; Heart Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Cardiovascular Abnormalities; Bone Diseases, Developmental; Heart Defects, Congenital; Funnel Chest
• Other Study ID Numbers: 2023-0400

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No