Autonomic Monitoring in Neurocardiogenic Syncope

Comparing Phenotypic and Autonomic Physiologic Determinants of Neurocardiogenic Syncope

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05907018

Acronym

ANSS

Enrollment

Registered

2023-06-18

Start date

2023-05-12

Completion date

2024-10-23

Last updated

2025-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Pain, Dyspnea, Syncope

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

7 Years to 24 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Autonomic data respiratory sinus arrhythmia among patients with chest pain	Data collected throughout cardiopulmonary exercise testing. Up to 90 minutes.	Subjects will wear an ambulatory monitor during testing
Autonomic data respiratory sinus arrhythmia among patients with syncope	Data collected throughout cardiopulmonary exercise testing. Up to 90 minutes.	Subjects will wear an ambulatory monitor during testing
Autonomic data respiratory sinus arrhythmia among patients post heart transplant	Data collected throughout cardiopulmonary exercise testing. Up to 90 minutes.	Subjects will wear an ambulatory monitor during testing

Countries

United States

Outcome results