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临床试验/NCT05298553
NCT05298553已完成不适用

Diagnostic Accuracy of WEARable TECHnology Single-lead ECG in Detecting Cardiac Arrhythmias: WEAR-TECH ECG

Oxford University Hospitals NHS Trust4 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年4月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
4
主要终点
Compare the accuracy of physician rhythm interpretation of 1-lead ECG generated by SkyLabs CART-I ring and Apple Watch versus 12-lead ECG (gold-standard)

研究概览

简要总结

Atrial fibrillation (AF) is the most common arrhythmia (irregular heart rhythm), affecting 1-2 million people in the UK. AF significantly increases the risk of an AF-related stroke, heart failure and dementia. A significant proportion of people will have no symptoms, and they may only be found to have AF after suffering an AF-related stroke.

An electrocardiogram (ECG) uses sensors placed on the skin to record the heart's electrical activity. A 12-lead ECG uses 10 sensors and is the gold-standard (best available test) to detect any abnormal heart rhythm disturbances. Until recently, a 12-lead ECG showing an irregular heart rhythm was required to make a diagnosis of AF but as AF episodes are often short and unpredictable it may be missed. Therefore, a small device that continuously records heartbeat and heart rhythm could make the diagnosis of arrhythmias and AF much quicker and easier.

Accessories such as watches or rings - referred to as wearable devices - have extremely good sensors that measure pulse rate by detecting small changes in skin colour during each heartbeat and can perform a single-lead ECG. Algorithms built in the wearable devices can identify irregular heart rhythms, such as atrial fibrillation.

The purpose of this study is to test two new wearable devices - the Skylabs CART-I ring and the Apple Watch - in detecting abnormal heart rhythm recording and recording ECGs. The investigators plan to recruit 500 patients attending Cardiology Departments in several hospitals in the UK and will ask them to wear the Apple Watch and the CART-I and perform 12-lead ECG with each device (two in total). No extra follow-up visits are required. At the end of the study, the investigators will compare interpretation by two cardiologists of the wearable devices' ECGs and the 12-lead ECGs and look at their ability to automatically detect abnormal rhythms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

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

  • Participant is willing and able to give informed consent for participation in the trial.
  • Male or female aged 18 years or above.
  • Indication for 12-lead ECG.

排除标准

  • Unable to comply with instructions.
  • Tattoos in the wrists or fingers where the device will be placed.
  • Severe skin allergy to silicone (Apple Watch wrist band) or nickel allergies.

研究组 & 干预措施

Group 1

Experimental

The order in which the wearable devices being investigated will be randomly assigned in a 1:1 fashion.

Simultaneous 12-lead ECG and single-lead ECG with the SkyLabs CART-I ring followed by the Apple Watch.

干预措施: Group A (Device)

Group 2

Experimental

The order in which the wearable devices being investigated will be randomly assigned in a 1:1 fashion.

Simultaneous 12-lead ECG and single-lead ECG with the Apple Watch followed by the SkyLabs CART-I ring.

干预措施: Group B (Device)

结局指标

主要结局

Compare the accuracy of physician rhythm interpretation of 1-lead ECG generated by SkyLabs CART-I ring and Apple Watch versus 12-lead ECG (gold-standard)

时间窗: 1 Day

Assessment of diagnostic accuracy of SkyLabs CART-I ring and Apple Watch 1-lead ECGs interpretation for different cardiac arrhythmias (atrial compared with a 12-lead ECG (gold-standard).

次要结局

  • Compare the accuracy of automatic AF detection of the SkyLabs CART-I Ring and Apple Watch versus a cardiologist interpretation of a 12-lead ECG (gold-standard)(1 Day)
  • Compare the accuracy of heart rate detection of the SkyLabs CART-I ring and Apple Watch 1-lead ECG to a 30-second 12-lead ECG(1 Day)
  • Compare the accuracy of ECG interval measurement for the SkyLabs CART-I Ring and Apple Watch to a 12-lead ECG (gold-standard)(1 Day)
  • Compare the accuracy of rhythm interpretation of SkyLabs CART-I ring 1-lead ECG to combined PPG (plethosysmography) signal and 1-lead ECG.(1 Day)

研究者

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

Tim Betts MD MBChB FRCP

Primary Investigator

Oxford University Hospitals NHS Trust

研究点 (4)

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