NCT07278089招募中不适用
Screening of Atrial Fibrillation/Arrhythmia Events in Patients With Abnormal Echocardiographic Parameters: The Randomized, Prospective SAFE-ECHO Study Design and Rationale
Tze-Fan Chao1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2025年3月17日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- the detection of AF either by 12-lead ECG or any episodes of AF lasting ≥ 30 seconds by the single-lead ECG or 7-day continuous recording.
研究概览
简要总结
To evaluate the feasibility of specific echocardiographic parameters as criteria for AF screening and to determine the AF detection yield of scheduled extended ECG monitoring compared to contemporary care.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who met any of the following criteria
- •LAE: defined as LAD ≥ 45 mm or LAVI > 34 ml/m2;
- •LVH: defined as LV septal or posterior wall thickness ≥ 15 mm;
- •E/e' > 14;
- •grade II or III diastolic dysfunction;
- •HF: defined as LVEF < 40% or LVEF ≥40% with clinical presentation compatible with Framingham criteria, New York Heart Association functional classification II-IV, and N-terminal pro-B type natriuretic peptide (NT-proBNP) > 125 pg/ml.
排除标准
- •Patients with a history of AF or atrial flutter, congenital heart disease, acute coronary syndrome undergoing urgent percutaneous coronary intervention within 3 months, uncontrolled hyperthyroidism, end-stage renal disease, unstable hemodynamic status or any known major comorbidities or medical conditions with expected life expectancy less than 1 year are excluded.
结局指标
主要结局
the detection of AF either by 12-lead ECG or any episodes of AF lasting ≥ 30 seconds by the single-lead ECG or 7-day continuous recording.
时间窗: 2 years
次要结局
未报告次要终点
研究者
Tze-Fan Chao
Doctor
Taipei Veterans General Hospital, Taiwan
研究点 (1)
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