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

NCT06110689 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-01-29

No results posted yet for this study

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

Interventions

OTHER

VU-AMS device

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

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Pornswan Ngamprasertwong, MD · Children's Hospital Medical Center, Cincinnati

Eligibility

Min Age
1 Day
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-03
Primary Completion
2024-11-25
Completion
2024-11-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06110689 on ClinicalTrials.gov