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OpenTrials
Completed

NCT Number: NCT06110689

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

VU-AMS device

Other

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

Primary outcomes

  1. 80% availability of respiratory sinus arrhythmia from cardiac MRI (magnetic resonance imaging)

    Time frame: Through MRI completion up to one hour

    Data collected during MRI

Other outcomes

  1. Describe difference in respiratory sinus arrhythmia in participants with Fontan

    Time frame: Through MRI completion up to one hour

    Collection of data from the cardiac MRI

  2. Describe difference in respiratory sinus arrhythmia in participants with pectus

    Time frame: Through MRI completion up to one hour

    Collection of data from the cardiac MRI

  3. Compare estimate of pre-ejection period (PEP)

    Time frame: Prior to MRI scan up to 10 minutes

    Collection of data from VU-AMS monitor

  4. Compare estimate of pre-ejection period (PEP)

    Time frame: Through MRI completion up to one hour

    Collection of data from the cardiac MRI

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Acronym: CMRI

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2023
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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