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Completed

NCT Number: NCT05907018

Autonomic Monitoring in Neurocardiogenic Syncope

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.

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Key information

Conditions

Syncope Chest Pain Consciousness Disorders Dyspnea Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Unconsciousness

Age range

7 year–24 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Autonomic data respiratory sinus arrhythmia among patients with chest pain

    Time frame: Data collected throughout cardiopulmonary exercise testing. Up to 90 minutes.

    Subjects will wear an ambulatory monitor during testing

  2. Autonomic data respiratory sinus arrhythmia among patients with syncope

    Time frame: Data collected throughout cardiopulmonary exercise testing. Up to 90 minutes.

    Subjects will wear an ambulatory monitor during testing

  3. Autonomic data respiratory sinus arrhythmia among patients post heart transplant

    Time frame: Data collected throughout cardiopulmonary exercise testing. Up to 90 minutes.

    Subjects will wear an ambulatory monitor during testing

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Comparing Phenotypic and Autonomic Physiologic Determinants of Neurocardiogenic Syncope

Acronym: ANSS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2023
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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