Clinical trial NCT06110689: Capturing Physiologic Autonomic Data from Clinically Indicated Magnetic Resonance Imaging Scans in Children
Official title: Capturing Physiologic Autonomic Data from Clinically Indicated Magnetic Resonance Imaging Scans in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pectus Excavatum
Cardiac Anomaly
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting for clinically indicated CMR scans with planned cine sequence and use of a respiratory bellows.

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: 80% availability of respiratory sinus arrhythmia from cardiac MRI (magnetic resonance imaging)
timeFrame: Through MRI completion up to one hour
Secondary outcomes:
Other outcomes:
measure: Describe difference in respiratory sinus arrhythmia in participants with Fontan
timeFrame: Through MRI completion up to one hour
measure: Describe difference in respiratory sinus arrhythmia in participants with pectus
timeFrame: Through MRI completion up to one hour
measure: Compare estimate of pre-ejection period (PEP)
timeFrame: Prior to MRI scan up to 10 minutes
measure: Compare estimate of pre-ejection period (PEP)
timeFrame: Through MRI completion up to one hour
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Pornswan Ngamprasertwong, MD
role: PRINCIPAL_INVESTIGATOR
References: