ANSS: Autonomic Monitoring in Neurocardiogenic Syncope
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Parent/Legal guardian able to provide informed consent
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Verbal participant assent
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Undergoing clinically indicated CPET.
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Diagnosis of either syncope, chest pain/dyspnea or status post OHT
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Participant willing and able to participate in study procedures
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Age 7-24 years
Exclusion Criteria:
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Participant unwilling or unable to participate
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Contraindication to adhesive placement, eg, epidermolysis bullosa
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Cancellation of the subject's planned CPET procedure.
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Tracheostomy tube presence (this will prevent proper placement of impedance cardiogram lead)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
Sponsors and Collaborators
- Children's Hospital Medical Center, Cincinnati
Investigators
- Principal Investigator: Jamie Sinton, MD, Children's Hospital Medical Center, Cincinnati
Study Documents (Full-Text)
None provided.More Information
Publications
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- Bottasso E. Toward the Existence of a Sympathetic Neuroplasticity Adaptive Mechanism Influencing the Immune Response. A Hypothetical View-Part II. Front Endocrinol (Lausanne). 2019 Sep 18;10:633. doi: 10.3389/fendo.2019.00633. eCollection 2019.
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- Sheldon RS, Grubb BP 2nd, Olshansky B, Shen WK, Calkins H, Brignole M, Raj SR, Krahn AD, Morillo CA, Stewart JM, Sutton R, Sandroni P, Friday KJ, Hachul DT, Cohen MI, Lau DH, Mayuga KA, Moak JP, Sandhu RK, Kanjwal K. 2015 heart rhythm society expert consensus statement on the diagnosis and treatment of postural tachycardia syndrome, inappropriate sinus tachycardia, and vasovagal syncope. Heart Rhythm. 2015 Jun;12(6):e41-63. doi: 10.1016/j.hrthm.2015.03.029. Epub 2015 May 14. No abstract available.
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