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

NCT06110689 | Completed

• 1 other identifier: 2023-0400
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pectus Excavatum; Cardiac Anomaly

Outcome Measures

Primary Outcomes (1)

• 80% availability of respiratory sinus arrhythmia from cardiac MRI (magnetic resonance imaging)

  Data collected during MRI

  Through MRI completion up to one hour

Other Outcomes (4)

• Describe difference in respiratory sinus arrhythmia in participants with Fontan

  Through MRI completion up to one hour

• Describe difference in respiratory sinus arrhythmia in participants with pectus

  Through MRI completion up to one hour

• Compare estimate of pre-ejection period (PEP)

  Prior to MRI scan up to 10 minutes

Study Arms (2)

Fontan

Patients undergoing cardiac MRI for Fontan,

Other: VU-AMS device

Healthy controls

Patients undergoing thoracic MRI for chest wall deformity.

Other: VU-AMS device

Interventions

VU-AMS device OTHER

Patients will wear the VU-AMS monitor prior to MRI.

Fontan; Healthy controls

Eligibility Criteria

• Age: 1 Day - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Funnel Chest; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases

Study Officials

• Pornswan Ngamprasertwong, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: November 1, 2023
• Study Start: October 3, 2023
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

US (1)