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临床试验/NCT05907018
NCT05907018已完成不适用

Comparing Phenotypic and Autonomic Physiologic Determinants of Neurocardiogenic Syncope

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年5月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Autonomic data respiratory sinus arrhythmia among patients with chest pain

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
7 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Autonomic data respiratory sinus arrhythmia among patients with chest pain

时间窗: 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

时间窗: 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

时间窗: Data collected throughout cardiopulmonary exercise testing. Up to 90 minutes.

Subjects will wear an ambulatory monitor during testing

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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