Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a clinical trial that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 40 participants.
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.
Interventions
- OTHER VU-AMS device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-10-03 |
| Est. Completion | 2024-11-25 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06110689
The ClinicalTrials.gov registry entry for NCT06110689 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which VU-AMS device is the first listed.
NCT06110689 reports 0 study locations.
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.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.