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临床试验/NCT05982652
NCT05982652进行中(未招募)不适用

Heart Rate Variability and Its Association With Symptom of Orthostatic Hypotension in Spinal Cord Injury

Pusan National University Yangsan Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
1
主要终点
Logistic regression analysis of heart rate variability variables according to OH and presence of symptom

研究概览

简要总结

In this study, the SCI patients were sub-grouped on the basis of symptoms into symptomatic and asymptomatic groups and measured HRV during resting and tilt up tests to compare their cardiovascular autonomic functions.

详细描述

In study protocol and the subjects were asked to lie down quietly for 5 minutes, closing their eyes and avoiding talking, moving hand, legs and body, and coughing during the test. R-R interval and blood pressure were measured beat-to-beat using Finometer® PRO (Finapres Medical Systems, Amsterdam, Netherlands) for 6 minutes each in two positions, supine and 60-degree angle on the tilt table.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • spinal cord injury with or without OH
  • aged 19 or older
  • ASIA Impairment Scale (AIS) A to D
  • neurological level of injury above T6.

排除标准

  • Those with heart and respiratory diseases, neurological diseases other than SCI - medically unstable states
  • Those who are taking medications affecting BP that cannot be stopped

结局指标

主要结局

Logistic regression analysis of heart rate variability variables according to OH and presence of symptom

时间窗: at the test time (15minutes)

the investigators conducted logistic regression analysis to evaluate the significance and impact of HRV variables associated with orthostatic hypotension and its symptoms in spinal cord injury patients.

Differences of heart rate variability between groups (OH vs non-OH, asymptomatic-OH vs symptomatic-OH group)

时间窗: at the test time (15minutes)

mean HR (heart rate), mean RR(RR interval), RMSSD (mean square of the successive R-R interval differences), SDNN (standard deviation of normal-to-normal interval), LF (low frequency) domain, HF(High frequency) domain

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hae-ri Park

doctor

Pusan National University Yangsan Hospital

研究点 (1)

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