Randomized Controlled Trial to Evaluate Implanted Event Recorders for the First Diagnosis of Atrial Fibrillation in High-risk Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Time to first diagnosis of atrial fibrillation
研究概览
简要总结
Atrial fibrillation (AF) is the most common clinical arrhythmia. AF is associated with increased risk for stroke due to blood clots formed in the fibrillating atria. Some patient characteristics increase the likelyhood of AF and at the same time the risk of stroke when AF has developed. To reduce the risk of stroke, anticoagulation therapy is recommended in patients with AF and risk factors (such as high blood pressure, diabetes, vessel disease). However, occasional (paroxysmal) AF may occur without symptoms and remain undetected, leaving patients at risk.
Aim of the prospective randomized study is to compare two management strategies for patients at increased risk for AF but without a known history of AF. Patients are seen regularly (monthly, then quarterly) for follow-up (incl. ECG recording and blood sample). One group of patients additionally receives a subcutaneous implantation of a loop recorder for continuous rhythm monitoring, while the control group remains on standard follow-up. Observation period is one year (optional extension for 3 years). The time to first diagnosis of AF is compared between groups, blood samples are analyzed for potential biomarkers of AF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •CHA2DS2-VASc risk score >= 4*
- •18 years or older
排除标准
- •known history of atrial fibrillation
- •implanted rhythm device
- •pre-existing indication for oral anticoagulation
- •(*)CHA2DS2-VASc: C - chronic heart failure (1 point); H - hypertension (1 point); A - age >= 75 years (2 points); D - diabetes (1 point); S - stroke (2 points); V - vascular disease (1 point); A - age >=65 and < 75 years (1 point); Sc - sex category (female) (1 point) ;
结局指标
主要结局
Time to first diagnosis of atrial fibrillation
时间窗: 12 months
次要结局
- Death(12 months)
- Stroke(12 months)
- Hospitalizations(12 months)
- Change in NTproBNP serum level associated with occurrence of atrial fibrillation(Baseline (0 months), 1,2,3,4,5,6,9 and 12 months)
- Time to change in therapy based on the diagnosis of atrial fibrillation(Baseline (0 months), 1,2,3,4,5,6,9 and 12 months)
研究者
Frank R Heinzel, MD, PhD
Associate Professor Frank R. Heinzel, MD, PhD
Medical University of Graz