DeteCtiON and Stroke PreventIon by MoDEl ScRreenING for Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,112
- 试验地点
- 4
- 主要终点
- Incident AF
研究概览
简要总结
Atrial fibrillation (AF) is the most common clinical arrhythmia and the prevalence increases with age. AF increases the risk of ischaemic stroke fivefold and accounts for almost one-third of all strokes. As AF is often asymptomatic there are many undetected cases. It is important to find patients with AF and additional risk factors for stroke in order to initiate oral anticoagulation treatment, which can reduce the risk of an ischaemic stroke by 60-70%. Screening is recommended in European guidelines, however the most suitable population and the most suitable device for AF detection remain to be defined.
The main objective of this study is to test the hypothesis that AF screening with 14-days continuous ECG monitoring in high-risk individuals identified with a risk prediction model is more effective than routine care in identifying patients with undetected AF.
Effectively detecting AF among patients with risk factors for ischaemic stroke has the potential to decrease mortality and morbidity, stroke burden and costs for the society as a whole.
详细描述
Objective(s): To compare the yield of atrial fibrillation (AF) using 14-days continuous ECG in a population aged ≥ 65 years with an increased risk for AF incidence according to the risk prediction model compared with standard of care in Region Halland.
Study Population: Residents in Region Halland age 65 and above.
Data Collection Methods: Electronic Health Records from Region Halland and 14-days continuous ECG recording using an ECG patch.
Study design:
Step 1:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Alive residents in the Halland region aged 65 or older without a recorded diagnosis of AF
排除标准
- •Known atrial fibrillation
- •No longer resident in Region Halland
- •Pacemaker, implantable cardioverter defibrillator or insertable monitor
- •Other indication for OAC treatment (such as VTE, mechanical heart valve replacement, VTE prophylaxis post surgery, mitral stenosis, left side intracardial thrombus)
结局指标
主要结局
Incident AF
时间窗: 14 days
1. Incident AF on ECG screening (intervention arms) defined as at least one episode of AF or atrial flutter with a duration of at least 30 seconds on ambulatory ECG recording. 2. Incident AF registered in the Electronic Health Record during follow-up (all four arms).
次要结局
- Yield newly diagnosed AF: RPM/ intervention arm versus RPM/ control arm(14 days)
- Yield newly diagnosed AF: general/ intervention arm versus general/ control arm(14 days)
- Yield newly diagnosed AF: general/ intervention arm versus RPM/ control arm(14 days)
研究者
Johan Engdahl, MD
Associate Professor, Senior consultant, Karolinska Institutet
Bristol-Myers Squibb