Clinical trial NCT05907018: Autonomic Monitoring in Neurocardiogenic Syncope
Official title: Comparing Phenotypic and Autonomic Physiologic Determinants of Neurocardiogenic Syncope
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Syncope
Chest Pain
Dyspnea
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll participants scheduled to undergo clinically indicated CPET procedures.

Brief summary: This is a prospective observational pilot study of suitability of autonomic monitoring via the VU-AMS device for prediction of neurocardiogenic syncope (NCS) in children referred to cardiopulmonary exercise testing (CPET) for a diagnosis of syncope. The study population is children referred for CPET to evaluate for neurocardiogenic syncope. The purpose is to describe autonomic function during rest and exercise and determine the positive predictive value of autonomic function measurements against the gold standard for diagnosis of neurocardiogenic syncope, the CPET. Children presenting for CPET with chest pain or who are status post orthotopic heart transplantation will serve as positive and negative controls respectively.


Eligibility criteria: Inclusion Criteria:

* Parent/Legal guardian able to provide informed consent
* Verbal participant assent
* Undergoing clinically indicated CPET.
* Diagnosis of either syncope, chest pain/dyspnea or status post OHT
* Participant willing and able to participate in study procedures
* Age 7-24 years

Exclusion Criteria:

* Participant unwilling or unable to participate
* Contraindication to adhesive placement, eg, epidermolysis bullosa
* Cancellation of the subject's planned CPET procedure.
* Tracheostomy tube presence (this will prevent proper placement of impedance cardiogram lead)

Primary outcomes:
measure: Autonomic data respiratory sinus arrhythmia among patients with chest pain
timeFrame: Data collected throughout cardiopulmonary exercise testing. Up to 90 minutes.
measure: Autonomic data respiratory sinus arrhythmia among patients with syncope
timeFrame: Data collected throughout cardiopulmonary exercise testing. Up to 90 minutes.
measure: Autonomic data respiratory sinus arrhythmia among patients post heart transplant
timeFrame: Data collected throughout cardiopulmonary exercise testing. Up to 90 minutes.
Secondary outcomes:
Other outcomes:
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
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