Autonomic Monitoring in Neurocardiogenic Syncope (ANSS)

January 27, 2025 updated by: Children's Hospital Medical Center, Cincinnati

Comparing Phenotypic and Autonomic Physiologic Determinants of 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will enroll participants scheduled to undergo clinically indicated CPET procedures.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Data collected throughout cardiopulmonary exercise testing. Up to 90 minutes.
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
Data collected throughout cardiopulmonary exercise testing. Up to 90 minutes.
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
Data collected throughout cardiopulmonary exercise testing. Up to 90 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Pornswan Ngamprasertwong, MD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2023

Primary Completion (Actual)

October 23, 2024

Study Completion (Actual)

October 23, 2024

Study Registration Dates

First Submitted

May 23, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0841

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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