Pectus ExcavatumCMRINCT06110689
Capturing Physiologic Autonomic Data from Clinically Indicated Magnetic Resonance Imaging Scans in Children
An observational study of Pectus Excavatum and Cardiac Anomaly, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 1 day to 30 years
- Conditions the study is for
- Pectus Excavatum, Cardiac Anomaly
- What is being tested?
- VU-AMS device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2023to 25 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients presenting for clinically indicated CMR scans with planned cine sequence and use of a respiratory bellows.
Who may be able to join
- 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
Who cannot join
- Patient or family refusal;
- Contraindication to study procedures
- Prior participation in the study (ie, we plan to sample without replacement)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
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.
- Conditions
- Pectus Excavatum, Cardiac Anomaly
- Being tested
- VU-AMS device
- Medical subject headings
- Funnel Chest, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VU-AMS deviceOther
Patients will wear the VU-AMS monitor prior to MRI.
| Study group | Role | What they receive |
|---|---|---|
| Fontan | Patients undergoing cardiac MRI for Fontan, Receives: Other: VU-AMS device | |
| Healthy controls | Patients undergoing thoracic MRI for chest wall deformity. Receives: Other: VU-AMS device |
What is being measured
The primary outcome is the main question the study is designed to answer.
80% availability of respiratory sinus arrhythmia from cardiac MRI (magnetic resonance imaging)
Data collected during MRI
Measured: Through MRI completion up to one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start3 Oct 2023
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pectus ExcavatumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pornswan Ngamprasertwong, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110689
- Sponsor's protocol ID
- 2023-0400
- Acronym
- CMRI
- Status last verified
- Jan 2025
- First submitted
- 19 Oct 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capturing Physiologic Autonomic Data from Clinically Indicated Magnetic Resonance Imaging Scans in Children
- ClinicalTrials.gov ID
- NCT06110689
- Acronym / sponsor ID
- CMRI / 2023-0400
- Conditions
- Pectus Excavatum, Cardiac Anomaly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fontan | – | Other: VU-AMS devicePatients undergoing cardiac MRI for Fontan, |
| Healthy controls | – | Other: VU-AMS devicePatients undergoing thoracic MRI for chest wall deformity. |
Who may qualify
- Ages
- 1 day to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients presenting for clinically indicated CMR scans with planned cine sequence and use of a respiratory bellows.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patient or family refusal;
- Contraindication to study procedures
- Prior participation in the study (ie, we plan to sample without replacement)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VU-AMS devicePatients will wear the VU-AMS monitor prior to MRI. | Other | Fontan, Healthy controls |
Primary outcome
80% availability of respiratory sinus arrhythmia from cardiac MRI (magnetic resonance imaging)
Time frame: Through MRI completion up to one hour
Data collected during MRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
Related trials for Pectus Excavatum
RecruitingObservational study
Biopsychosocial Risk Influences on the Development and Generation of Early-Onset Chronic Pain
Juvenile Idiopathic Arthritis (JIA), Fibromyalgia
Active, not recruitingObservational study
Postoperative and Chronic Pain Genetic Spine and Pectus Surgery Study
Scoliosis, Kyphosis
Recruiting
ES Catheter vs Cryoablation After Pectus Surgery
Pectus Excavatum
Active, not recruiting
Comprehensive Study of Post-surgical Pain After Pectus or Spine Surgery
Pain, Postoperative, Excavatum, Pectus
Active, not recruiting
Pectus Excavatum Camouflage (IT)
Pectus Excavatum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pornswan Ngamprasertwong, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pectus Excavatum and Cardiac Anomaly, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
80% availability of respiratory sinus arrhythmia from cardiac MRI (magnetic resonance imaging) (time frame: Through MRI completion up to one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.