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

Pectus Excavatum Clinical Trial

— CMRI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06110689
• Other study ID #: 2023-0400
• Status: Recruiting
• Start date: October 3, 2023
• Est. completion date: February 2025

Study information

• Verified date: October 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Jamie Sinton, MD
• Phone: (419) 236-7480
• Email: jamie.sinton[@]cchmc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Anomaly
• Funnel Chest
• Heart Defects, Congenital
• Pectus Excavatum

Intervention

Other:
• VU-AMS device
Patients will wear the VU-AMS monitor prior to MRI.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Describe difference in respiratory sinus arrhythmia in participants with Fontan	Collection of data from the cardiac MRI	Through MRI completion up to one hour
Other	Describe difference in respiratory sinus arrhythmia in participants with pectus	Collection of data from the cardiac MRI	Through MRI completion up to one hour
Other	Compare estimate of pre-ejection period (PEP)	Collection of data from VU-AMS monitor	Prior to MRI scan up to 10 minutes
Other	Compare estimate of pre-ejection period (PEP)	Collection of data from the cardiac MRI	Through MRI completion up to one hour
Primary	80% availability of respiratory sinus arrhythmia from cardiac MRI (magnetic resonance imaging)	Data collected during MRI	Through MRI completion up to one hour