Autonomic Monitoring in Neurocardiogenic Syncope

Completed

• Conditions: Chest Pain; Dyspnea; Syncope

• Registration Number: NCT05907018
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-12
• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-18
• Primary Completion: 2024-10-23
• Study Completion: 2024-10-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 post heart transplant	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

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States