Autonomic Monitoring in Neurocardiogenic Syncope

Dyspnea Clinical Trial

— ANSS  

Official title:

Comparing Phenotypic and Autonomic Physiologic Determinants of Neurocardiogenic Syncope

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05907018
• Other study ID #: 2022-0841
• Status: Enrolling by invitation
• Start date: May 12, 2023
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 24 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chest Pain
• Dyspnea
• Syncope

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (11)

Akselrod S, Gordon D, Ubel FA, Shannon DC, Berger AC, Cohen RJ. Power spectrum analysis of heart rate fluctuation: a quantitative probe of beat-to-beat cardiovascular control. Science. 1981 Jul 10;213(4504):220-2. doi: 10.1126/science.6166045. — View Citation

Bottasso E. Toward the Existence of a Sympathetic Neuroplasticity Adaptive Mechanism Influencing the Immune Response. A Hypothetical View-Part I. Front Endocrinol (Lausanne). 2019 Sep 20;10:632. doi: 10.3389/fendo.2019.00632. eCollection 2019. — View Citation

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. — View Citation

Dahlqvist JA, Karlsson M, Wiklund U, Hornsten R, Stromvall-Larsson E, Berggren H, Hanseus K, Johansson S, Rydberg A. Heart rate variability in children with Fontan circulation: lateral tunnel and extracardiac conduit. Pediatr Cardiol. 2012 Feb;33(2):307-15. doi: 10.1007/s00246-011-0126-2. Epub 2011 Oct 8. — View Citation

Grossman P, Taylor EW. Toward understanding respiratory sinus arrhythmia: relations to cardiac vagal tone, evolution and biobehavioral functions. Biol Psychol. 2007 Feb;74(2):263-85. doi: 10.1016/j.biopsycho.2005.11.014. Epub 2006 Nov 1. — View Citation

Grossman P, van Beek J, Wientjes C. A comparison of three quantification methods for estimation of respiratory sinus arrhythmia. Psychophysiology. 1990 Nov;27(6):702-14. doi: 10.1111/j.1469-8986.1990.tb03198.x. — View Citation

Harteveld LM, Nederend I, Ten Harkel ADJ, Schutte NM, de Rooij SR, Vrijkotte TGM, Oldenhof H, Popma A, Jansen LMC, Suurland J, Swaab H, de Geus EJC; FemNAT-CD collaborators *. Maturation of the Cardiac Autonomic Nervous System Activity in Children and Adolescents. J Am Heart Assoc. 2021 Feb 16;10(4):e017405. doi: 10.1161/JAHA.120.017405. Epub 2021 Feb 2. — View Citation

Saklani P, Krahn A, Klein G. Syncope. Circulation. 2013 Mar 26;127(12):1330-9. doi: 10.1161/CIRCULATIONAHA.112.138396. No abstract available. — View Citation

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. — View Citation

Vinik AI, Ziegler D. Diabetic cardiovascular autonomic neuropathy. Circulation. 2007 Jan 23;115(3):387-97. doi: 10.1161/CIRCULATIONAHA.106.634949. No abstract available. — View Citation

Willemsen GH, De Geus EJ, Klaver CH, Van Doornen LJ, Carroll D. Ambulatory monitoring of the impedance cardiogram. Psychophysiology. 1996 Mar;33(2):184-93. doi: 10.1111/j.1469-8986.1996.tb02122.x. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autonomic data respiratory sinus arrhythmia among patients with chest pain	Subjects will wear an ambulatory monitor during testing	Data collected throughout cardiopulmonary exercise testing. Up to 90 minutes.
Primary	Autonomic data respiratory sinus arrhythmia among patients with syncope	Subjects will wear an ambulatory monitor during testing	Data collected throughout cardiopulmonary exercise testing. Up to 90 minutes.
Primary	Autonomic data respiratory sinus arrhythmia among patients post heart transplant	Subjects will wear an ambulatory monitor during testing	Data collected throughout cardiopulmonary exercise testing. Up to 90 minutes.