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CompletedNCT06110689CMRIUpdated Jan 29, 2025

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

An observational study in Pectus Excavatum and Cardiac Anomaly, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 1 Day to 30 Years. Per ClinicalTrials.gov, last updated 2025-01-29.

Sponsored by Children's Hospital Medical Center, Cincinnati · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
40
Ages
1 Day to 30 Years
Sex
All
01

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.

02

Conditions studied

  • Pectus Excavatum
  • Cardiac Anomaly
03

Who can participate

Ages eligible
1 Day to 30 Years
Sexes eligible
All
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.

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

Exclusion Criteria:

  • Patient or family refusal;
  • Contraindication to study procedures
  • Prior participation in the study (ie, we plan to sample without replacement)
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherVU-AMS device

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

05

What researchers measure

Primary outcomes

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

    Data collected during MRI

    Time frame: Through MRI completion up to one hour

Other outcomes

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

    Collection of data from the cardiac MRI

    Time frame: Through MRI completion up to one hour

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

    Collection of data from the cardiac MRI

    Time frame: Through MRI completion up to one hour

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

    Collection of data from VU-AMS monitor

    Time frame: Prior to MRI scan up to 10 minutes

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

    Collection of data from the cardiac MRI

    Time frame: Through MRI completion up to one hour

06

Study locations

1 site
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
07

Registry details

Key details

Study ID
NCT06110689
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Responsible party
Sponsor
First posted
Nov 1, 2023
Start date
Oct 3, 2023
Primary completion
Nov 25, 2024
Completion
Nov 25, 2024
Last update
Jan 29, 2025

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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