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NCT06110689 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Children's Hospital Medical Center, Cincinnati.

Completed
Registry status
40
Enrollment target

NCT06110689: Completed study, sponsored by Children's Hospital Medical Center, Cincinnati.

NCT06110689 is a clinical trial that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 40 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06110689 has completed, sponsored by Children's Hospital Medical Center, Cincinnati.

COMPLETED
Registry status
40 participants
Enrollment target

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.

Primary Outcome

Data collected during MRI

Interventions

  • OTHER VU-AMS device

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2023-10-03
Est. Completion 2024-11-25

What the finished NCT06110689 record still lists

NCT06110689 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which VU-AMS device is the first listed.

NCT06110689 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06110689 about?

NCT06110689 is a clinical study titled "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 v...

What is the current status of trial NCT06110689?

This trial is currently completed. The enrollment target is 40 participants. The study started on 2023-10-03. Estimated completion is 2024-11-25.

What interventions are being tested in trial NCT06110689?

The interventions under investigation include: VU-AMS device (OTHER).

Who is sponsoring clinical trial NCT06110689?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT06110689, the US trial registry maintained by the National Library of Medicine. NCT06110689 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.