Genetic Risk-Based Atrial Fibrillation Screening
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 726
- 试验地点
- 1
- 主要终点
- Detection of atrial fibrillation/atrial flutter (Y/N)
研究概览
简要总结
AF is the most common sustained arrhythmia in adults and its prevalence increases with advancing age.
In this study, we aim to determine whether the published genome-wide polygenic scores for atrial fibrillation (GPSAF) can facilitate AF screening by accurately discriminating between patients with low and high risk for AF.
All included patients are participating in the MHI biobank, an ongoing funded institutional DNA bank and clinical registry approved by the research ethics board where included patients consent for future genetic research.
The study will compare AF detection rate using a 3 months near continuous monitoring in individuals with a high GPSAF with matched individuals from the bottom GPSAF.
详细描述
In Canada, 50,000 strokes occur every year and can have devastating consequences on patients. Approximately 15% of strokes are attributable to an undiagnosed arrhythmia, atrial fibrillation (AF). Strokes due to AF are more severe and lethal but are preventable with anti-coagulation. Most patients who suffer from AF are asymptomatic and thus don't come spontaneously to medical attention. The diagnosis can be made by electrocardiographical (ECG) recording. As longer recordings spanning on weeks and months are often required, it is not possible to apply this intense screening to the entire population. The GeneAF project thus aims to use genetic information to identify and target patients who benefit the most from a more intensive screening approach. A previously published genetic polygenic risk score (GPS) for AF has been shown to be associated with prevalent AF in the UK biobank population. Participants in the top 5 percentile were three times more likely to have a history of AF (prevalent AF).
The aim of this project is to determine if the use of this previously published GPS score for prevalent AF can be used to screen for silent incident AF in our population.
Primary objective: To assess the association of GPSAF with silent AF and compare AF detection rates in patients with a high GPSAF to matched controls.
Secondary objectives: To determine the proportion of patients with identified AF who will be prescribed anticoagulation during follow-up.
Methods:
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
- 否
入选标准
- •Having a CHADS65 score>1, which requires either:
- •Age >= 65 and/or A prior Stroke or TIA and/or Hypertension and/or A history of heart failure and/or Diabetes
排除标准
- •Already on oral anticoagulation
- •Any prior history of AF or atrial flutter (AFl)
- •Patients currently having an implantable device (pacemaker, defibrillator or loop recorder) that allows detection of AF/AFl
- •Refusing testing with the "Apple Watch"
结局指标
主要结局
Detection of atrial fibrillation/atrial flutter (Y/N)
时间窗: 3 months
Atrial Fibrillation will be diagnosed according to the standard definition: "at least one 30-second recording with irregular rhythm without p waves". This will be accomplished either through the baseline ECG, Holter or during the 3 months monitoring with the Apple watch. The diagnostic of AF with the "Apple watch" requires: 1. Detection of irregular heart rate (photopletysmography) 2. Confirmation of the rhythm with a real time single lead 30 seconds ECG with the Apple Watch.
次要结局
未报告次要终点
研究者
Julia Cadrin-Tourigny
Cardiologist electrophysiologist
Montreal Heart Institute