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Autonomic Monitoring in Neurocardiogenic Syncope (ANSS)

Cincinnati Children's Hospital Medical Center logo

Cincinnati Children's Hospital Medical Center

Status

Completed

Conditions

Syncope
Dyspnea
Chest Pain

Study type

Observational

Funder types

Other

Identifiers

NCT05907018
2022-0841

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

7 to 24 years old

Volunteers

No 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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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