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临床试验/NCT03753139
NCT03753139已完成不适用

Identification of Arrhythmias With One-time ECG

Kuopio University Hospital1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2018年11月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
260
试验地点
1
主要终点
Heart rhythm monitoring with single-lead ECG

研究概览

简要总结

In Western countries, every sixth person in their lifetime and 15,000 people in Finland have a new stroke each year. About every fourth stroke is based on cardiac embolism. Atrial fibrillation causes formation of thrombi in the left atrium with ensuing embolization in the cerebral and peripheral circulation.

This study investigates the suitability of measurement techniques and new calculation methods used in sport/wellness technology for the screening and diagnosis of atrial fibrillation and other arrhythmias. New measurement technologies, the one-time ECG measurement and pulse wristband measurement, are studied for their characteristics, data quality and rhythm recognition. Identifying latent arrhythmias with new self-monitoring technologies can significantly reduce the number of strokes (the latent arrhythmias causes about 25% of strokes).

The research will be accomplished in cooperation with the Kuopio University Hospital Emergency Department, the Heart Center, the Department of Applied Physics of the University of Eastern Finland and Heart2Save Ltd.

The results of the research project will be published in the scientific journals of medicine and medical technology and will be presented at scientific conferences of the respective fields. The research results of the project can be utilized by all companies in the medical technology industry, in particular companies that produce ECG measuring instruments and companies that produce rhythm recognition software.

详细描述

The research aims to solve the following medical problems:

  1. Identifying and defining the type of atrial fibrillation is problematic due to its spontaneous occurrence and latency.
  2. Measurement devices for screening atrial fibrillation are poorly available.

The main research questions are:

  1. Can a single-lead ECG measurement be used to detect arrhythmias

  2. Find out the measurement locations (ECG leads) for single-lead ECG self-monitoring and evaluate the impact of measurement locations on usability and signal quality.

  3. Find out the measurement locations for single-lead ECG monitoring when the measurement is performed by another person (nurse or relative) and evaluate the impact of measurement locations on usability and signal quality.

  4. Find out the reliability of single-lead ECG measurement for the identification of atrial fibrillation.

  5. Find out the reliability of single-lead ECG measurement for identification of rapid (tachycardia) and slow heart rate (bradycardia).

  6. Can a wristband based on optical pulse registration be able to obtain reliable information about arrhythmias

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Patients treated for any reason in the emergency department of Kuopio University Hospital.

排除标准

  • body mass index (BMI) over 35, implanted heart pacemaker device and a medical condition requiring immediate treatment that would be delayed by the study measurements.

结局指标

主要结局

Heart rhythm monitoring with single-lead ECG

时间窗: 30 minutes

Sensitivity and Specificity for the atrial fibrillation detection

次要结局

未报告次要终点

研究者

发起方
Kuopio University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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