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临床试验/NCT02843516
NCT02843516已完成不适用

Detection Rate of Atrial Fibrillation in Patients Implanted With ILRs

Cambridge University Hospitals NHS Foundation Trust0 个研究点目标入组 500 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
主要终点
Incidence of Atrial Fibrillation in patients with and without previous stroke

研究概览

简要总结

Implantable Loop Recorders (ILRs), are subcutaneous heart monitors, which are implanted for different reasons including syncope (fainting), pre syncope (near fainting), palpitations and stroke. They monitor the heart and detect abnormalities.

Atrial fibrillation (irregular heart rhythm),is a common cardiac arrhythmia associated with a five-fold risk of stroke. Atrial Fibrillation increases the risk of stroke in patients to a different degree according to a risk stratification score. Anticoagulation is recommended to all high-risk patients.

Recent published studies have shown a high incidence of Atrial Fibrillation detected by ILRs in patients with previous stroke.

It is not known whether a similar incidence of Atrial Fibrillation occurs in patients without previous stroke. It is also not know ''how much'' Atrial Fibrillation is necessary to increase the risk of stroke, how relevant the finding of Atrial Fibrillation is and whether everybody with Atrial Fibrillation should have anticoagulation or whether a "bit of Atrial Fibrillation" is actually normal in most people.

The purpose of this study is to identify and compare the rate and the burden of Atrial Fibrillation (more or less than 30 seconds) in patients with and without previous stroke.

Medical notes and Implantable Loop Recorder records of the patients that had the devices implanted in Addendbrooke's Hospital from March 2009 up to 1 month after the implantation of the latest device will be inspected in order to identify whether the device had detected Atrial Fibrillation and if so the burden of Atrial Fibrillation in the two different groups of patients (with and without previous stroke).

The risk of stroke for each patient will be calculated. Echocardiographic (ultrasound scan of the heart)risk factors for Atrial Fibrillation will be identified and compared between the two groups.

This is going to be a retrospective study and we will be inspecting patients' data only.

详细描述

Implantable Loop Recorders (ILRs), are subcutaneous heart monitors, which are implanted for different reasons including syncope (fainting), pre syncope (near fainting), palpitations and stroke. They monitor the heart and detect abnormalities.

Atrial fibrillation (irregular heart rhythm),is a common cardiac arrhythmia associated with a five-fold risk of stroke. Atrial Fibrillation increases the risk of stroke in patients to a different degree according to a risk stratification score. Anticoagulation is recommended to all high-risk patients.

Recent published studies have shown a high incidence of Atrial Fibrillation detected by ILRs in patients with previous stroke.

It is not known whether a similar incidence of Atrial Fibrillation occurs in patients without previous stroke. It is also not know ''how much'' Atrial Fibrillation is necessary to increase the risk of stroke, how relevant the finding of Atrial Fibrillation is and whether everybody with Atrial Fibrillation should have anticoagulation or whether a "bit of Atrial Fibrillation" is actually normal in most people.

The purpose of this study is to identify and compare the rate and the burden of Atrial Fibrillation (more or less than 30 seconds) in patients with and without previous stroke.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

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

  • Male or Female, aged 18 years or above.
  • Patients with Implantable Loop Recorder

排除标准

  • 未提供

结局指标

主要结局

Incidence of Atrial Fibrillation in patients with and without previous stroke

时间窗: 6 years

次要结局

未报告次要终点

研究者

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

Peter J Pugh

Consultant Cardiologist

Cambridge University Hospitals NHS Foundation Trust

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