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临床试验/NCT06482320
NCT06482320招募中不适用

Diagnostic Accuracy in the Detection of Arrhythmias of Patient Recorded ECGs With Smart WATCH TIMEly Performed During Palpitations

University Hospital of Ferrara1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Assessment of diagnostic accuracy of 1-lead ECGs interpretation for different cardiac arrhythmias (compared to standard ecg or h24-h holter)

研究概览

简要总结

Approximately 100 patients with heart palpitations over the age of 22, in possession of smartwatches capable of recording a single-lead ECG will be enrolled.

The study plans to evaluate the performance in the diagnosis of arrhythmia of single-lead ECGs self-recorded by patients during heart palpitations using a smartwatch.

详细描述

The patient who complains of palpitations can undergo multiple evaluations in the absence of a definitive diagnosis, especially in the case of paroxysmal arrhythmias of short duration. There are methods that allow prolonged cardiac rhythm recordings but which in clinical practice are not always available even in the face of high costs. Smartwatches capable of recording single-lead ECGs are increasingly popular even among patients who come to health services complaining of heart palpitations. The traces recorded can be diagnostic for atrial fibrillation but cases suggesting other types of arrhythmias are also reported, later confirmed by further investigations.

Therefore, the patient with heart palpitations who already owns a Smart Watch capable of recording ECGs can, if adequately involved, contribute in an innovative and economic way to the diagnosis of arrhythmia.

The rationale of this study is to evaluate the performance in the diagnosis of arrhythmia of the ECGs sent via smartwatch by patients in case of heart palpitations.

This is an observational, prospective, non-randomized multicenter study that involves the collection of clinical and electrocardiographic data of patients (over the age of 22) referring to the outpatient clinics of the participating centers for heart palpitations, owners of Smart Watches capable of recording ECGs.

Before enrollment, the Smart Watch will be identified by checking whether it belongs to the list of devices capable of recording single-lead ECG Upon enrollment, enrolled patients are associated with an identification number with progressive numbering (ID). They will then be instructed to record a basal mono-lead ECG (ECG 0) using their smart watch and will be invited to send the recorded file to a separate and specific e-mail address dedicated to the study for each participating centre. The sender's e-mail address will be recorded and associated with the ID of the enrolled patient, becoming the only element capable of providing an association between traces sent in the future and the belonging ID. The main clinical and personal data including the telephone number will also be collected.

研究设计

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

入排标准

年龄范围
22 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients attending the outpatient clinics of the participating heart palpitations owners of smartwatches and mobile phones capable of recording a single-lead ECG on request
  • Patients 22 years of age and older
  • Patients able to send recorded traces in PDF format by e-mail.
  • Signature of consent

排除标准

  • Under 22 years of age
  • Carriers of ICDs, S-ICDs, pacemakers, loop recorders.
  • Known left bundle branch block although frequency dependent on a previous baseline ECG or Holter ECG
  • Known right bundle branch block with QRS duration greater than or equal to 120 ms even if frequency dependent on a previous baseline ECG or Holter ECG
  • State of pregnancy;

结局指标

主要结局

Assessment of diagnostic accuracy of 1-lead ECGs interpretation for different cardiac arrhythmias (compared to standard ecg or h24-h holter)

时间窗: 3 month after the enrollment

Assessment of diagnostic accuracy of 1-lead ECGs interpretation for different cardiac arrhythmias (compared to standard ecg or h24-h holter)

Compare the accuracy of physician rhythm interpretation vs interpretation of 1-lead ECG generated provided by the Watch.

时间窗: 3 month after the enrollment

Compare the accuracy of physician rhythm interpretation vs interpretation of 1-lead ECG generated provided by the Watch

次要结局

  • evel of agreement of measured interval duration between the Watch 1-lead ECG and a 12-lead ECG.(3 month after the enrollment)
  • Compare the accuracy of automatic AF detection of the Watch versus a cardiologist interpretation of a 12-lead ECG (gold-standard)(3 month after the enrollment)

研究者

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

研究点 (1)

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