跳至主要内容
临床试验/NCT05526170
NCT05526170进行中(未招募)不适用

Personalized Detection of Triggers and Risk Factors for Recurrence of Atrial Fibrillation and Other Atrial Arrhythmias With the Use of Long-term Monitoring

Vilnius University1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2021年8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
182
试验地点
1
主要终点
Blood pressure association with atrial arrhythmias in patients with previously diagnosed atrial fibrillation

研究概览

简要总结

A prospective cohort study to evaluate the association between various triggers encountered in daily life and induction of atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia and premature atrial contractions) with the use of long-term monitoring devices. The collected data of personalized triggers and risk factors will be used to define the individual phenotype of atrial arrhythmia.

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

入选标准

  • Patients with previously diagnosed paroxysmal or persistent atrial fibrillation who are in sinus rhythm at inclusion time.
  • An informed consent is signed by the patient.

排除标准

  • The qualifying episode of AF has never been documented in ECG or Holter ECG monitoring.
  • Patients with atrial fibrillation, atrial flutter or atrial tachycardia at inclusion time.
  • Patients with permanent atrial fibrillation or permanent atrial flutter.
  • Age <18 years.
  • Patients with a pacemaker or an implanted cardiovert-defibrillator.
  • Patients suffering from dementia or other severe neurological disorders and thus incapable to participate.
  • Patients who present with antisocial behavior and/or do not want to participate in the study.

结局指标

主要结局

Blood pressure association with atrial arrhythmias in patients with previously diagnosed atrial fibrillation

时间窗: 7 days

Patterns of blood pressure fluctuations in relation to atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia, premature atrial contractions) within a monitoring period of 7 days. An association between episodes of uncontrolled arterial hypertension and occurrence of arrhythmia episodes is anticipated.

次要结局

  • Association of physical activity to predict the risk of atrial arrhythmias in patients with previously diagnosed atrial fibrillation(7 days)
  • Usability of devices in everyday use(1 day)
  • Association of various triggers with atrial arrhythmias in patients with previously diagnosed atrial fibrillation(7 days)
  • Potential triggers named by participants, symptoms, burden of arrhythmia and the quality of life in patients with previously diagnosed atrial fibrillation after the collected information is presented to the patients(3 months after the collected information is presented to the patient)
  • Potential triggers named by participants, symptoms, burden of arrhythmia and the quality of life in patients with previously diagnosed atrial fibrillation before monitoring(1 day)
  • Association of available blood tests results to predict the risk of atrial arrhythmias in patients with previously diagnosed atrial fibrillation(3 months prior to 3 months after inclusion)
  • Association of echocardiographic results to predict the risk of atrial arrhythmias in patients with previously diagnosed atrial fibrillation(3 months prior to 3 months after inclusion.)
  • Association of sleep analysis data with atrial arrhythmias in patients with previously diagnosed atrial fibrillation(7 days)
  • Temporal relation between changes in blood pressure and atrial arrhythmias in patients with previously diagnosed atrial fibrillation(7 days)
  • Association of parasympathetic and sympathetic tone to predict the risk of atrial arrhythmias in patients with previously diagnosed atrial fibrillation(7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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