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临床试验/NCT02960334
NCT02960334已完成不适用

Screening for Actionable Atrial Fibrillation During Preoperative Consultation With the MyDiagnostick

Martini Hospital Groningen1 个研究点 分布在 1 个国家目标入组 505 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
505
试验地点
1
主要终点
Presence of AF

研究概览

简要总结

Atrial Fibrillation (AF) It is the most common arrhythmia in the world. It carries great public health significance because of its prevalence, additional morbidity and mortality. It provides a 4-5 times higher risk of developing a ischemic stroke or transient ischemic attack. In term, this risk can be 70% reduced by taking oral anticoagulants. Actionable AF is the overarching term for silent AF (asymptomatic AF) and undertreated AF (known AF, but not sufficiently protected against ischemic stroke). It is recommended that over the age of 65, patients should be screened with pulse palpation or rhythm strip for the presence of AF. The MyDiagnostick is a single-lead I, compact hand-held device that analyses heart rhythm during one minute. During preoperative consultation, this device will be used to value the yield of screening for actionable AF.

详细描述

Atrial fibrillation (AF) is the most common arrhythmia in the world, with a prevalence ranging from 1.9 - 2.3% and rising. It is known that the disease occurs more often as age progresses: 70% of affected cases are aged between 65 and 85, over 80 years, one is 10-18% likely to be carrying the illness. Multiple risk factors for developing AF have been determined, like hypertension, myocardial infarction, heart failure, valvular heart disease, obesity, DM and hyperthyroidism.

AF potentially leads to thrombus formation, resulting in a 4-5 times increased risk of getting a TIA or ischemic infarction.

Taking a 12 lead electrocardiogram (ECG) remains the golden standard, with the absence of distinct P-waves and a RR interval that is irregularly irregular.

AF is a risk factor and a risk marker for developing ischemic stroke, by providing a prothrombotic environment. This makes a patient with AF 4-5 times more susceptible for getting an ischemic stroke. Protection for this risk is done by prescribing oral anticoagulants (OAC) (according to an individuals CHA2DS2VASc-score) by either Vitamin-K antagonists (VKAs) or Novel Oral Anticoagulants (NOACs). This allows for a 70% stroke risk reduction.

Not all AF is known to its carrier, it has been proven that 30% of all cases proceeds asymptomatic. These patients are unknowingly exposed to a higher stroke risk. Undertreated AF is when AF is known, but OAC is unrightfully withheld. In approximately 20% of all AF-related strokes, AF was known but undertreated.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • >64 years of age, visiting preoperative consultation

排除标准

  • <64 years of age

结局指标

主要结局

Presence of AF

时间窗: Single time point (when the patient visits the preoperative consultation hour)

The MyDiagnostick shows regular or irregular RR-interval

次要结局

  • Usage of OAC(Single time point (when the patient visits the preoperative consultation hour))

研究者

发起方
Martini Hospital Groningen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eva Roseboom

Student

Martini Hospital Groningen

研究点 (1)

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