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临床试验/NCT02530021
NCT02530021Unknown不适用

Sixty Minutes Heart Rate Variability Testing Compared With Non-invasive Exercise Stress Test in Hospitalized Patients With Suspected Angina Pectoris

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Correlation betwen Heart rate variability test and non-onvasive testing

研究概览

简要总结

There are many patients hospitalized for chest pain, which don't have high risk features that require invasive coronary angiography, but are considered intermediate risk and for which ischemic heart disease can not be excluded.

The current management for these patients is to perform a non invasive test in order to classify their risk.

Exercise ergometry is a commonly used non invasive test to detect ischemia. that test is non-invasive, and does not involve radiation or intra-venous contrast. The test is limited for many patients, because of un-ability to exercise, or because of non-interpetable Electro Cardio-Graphy (ECG).

Heart rate variability is well known to be a marker of ischemic heart disease. Heart rate variability testing is a non-invasive ECG monitoring technique.

The study design is to identify hospitalized patients who are candidates for non-invasive stress testing, and to monitor their heart rate variability for one hour prior to the stress test.

详细描述

Ischemic heart disease is among the leading causes of death and disability in the modern world. Effective treatment for cardiac ischemia is based on identification of the proper patients and assigning prompt treatment to those patients.

It is not simple identifying the proper patients. There are many patients complaining of typical anginal chest pain without coronary heart disease, and there are many patients with active angina who complain of non-typical symptoms or who don't feel any symptoms.

Management of hospitalized patients with suspected angina pectoris is based on their complaints, their risk factors and laboratory results (ECG, troponin). They are classified into low-risk, high risk and intermediate.

Intermediate risk patients usually require additional testing in the hospital in order to re-classify them into high or low risk.

Heart rate variability is a well-known marker of active cardiac ischemia. The investigators plan to perform a 60 minute heart rate variability monitoring.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients
  • Hospitalized for Chest pain
  • Intermediate probability for ischemic heart disease
  • Selected management strategy is non invasive cardiac stress testing

排除标准

  • Active Ischemic symptoms
  • ECG changes suggestive of myocardial ischemia
  • Troponin elevation on blood tests
  • Atrial flutter
  • Multiple APB's or VPB's on resting ECG

结局指标

主要结局

Correlation betwen Heart rate variability test and non-onvasive testing

时间窗: The time from non-invasive testing to hospital discharg. Estimated up to 5 Days

Heart rate variability results will be compared to non-invasive test results ordered as routine care by treating physician.

次要结局

  • Correlation between Heart rate variability and invasive angiography(Time from non-invasive testing to coronary angiography. Estimated up to 5 days)

研究者

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

Arnson Yoav

Dr.

Meir Medical Center

研究点 (1)

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