NCT05907018|Completed
Autonomic Monitoring in Neurocardiogenic Syncope
ANSS
Comparing Phenotypic and Autonomic Physiologic Determinants of Neurocardiogenic Syncope
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ANSS
Comparing Phenotypic and Autonomic Physiologic Determinants of Neurocardiogenic Syncope
Sponsor study identifier
observational
40
1 country
1
Study Start
May 12, 2023
Actual (reported)Primary Completion
October 23, 2024
Actual (reported)Study Completion
October 23, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 23, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 12, 2023
Actual (reported)May 23, 2023
Actual (reported)June 18, 2023
Actual (reported)October 23, 2024
Actual (reported)October 23, 2024
Actual (reported)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.
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.
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.
The study will enroll participants scheduled to undergo clinically indicated CPET procedures.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
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Pornswan Ngamprasertwong, MD
Children's Hospital Medical Center, Cincinnati
40 participants (actual enrollment reported by the registry).
First Submitted
May 23, 2023
First Posted
June 18, 2023
Study Start
May 12, 2023
Actual (reported)Improving Management of Emergency Department Patients With Undifferentiated Syncope: Prospective Validation of the Canadian Syncope Risk Score
Contact the study team to confirm eligibility.
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.
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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.
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.
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.
Saklani P, Krahn A, Klein G. Syncope. Circulation. 2013 Mar 26;127(12):1330-9. doi: 10.1161/CIRCULATIONAHA.112.138396. No abstract available.
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.
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.
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.
Primary Completion
October 23, 2024
Actual (reported)Study Completion
October 23, 2024
Actual (reported)Last Updated
January 29, 2025
Record last verified: 2025-01
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