Rhythm Control of AF in Patients With Acute Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- acute stroke with AF
研究概览
简要总结
Prospective randomized (rhythm control or rate control) Objective of study
- To analyze long term outcome of patients with acute stroke with atrial fibrillation according to the rhythm control
- To analyze recurrence rate of atrial fibrillation or recurrence stroke in patients with acute stroke according to the rhythm control (by antiarrhythmic drug, cardioversion, catheter ablation)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Atrial fibrillation (20~80 years old)
- •patients with Acute stroke within 7 days
- •LA diameter < 55mm
- •patients possible to anticoagulation and anti arrhythmic drug
- •NIHSS score ≤12
排除标准
- •Hemorrhagic transformation
- •Large cerebral lesion or cerebellar lesion (more than 1/3 of MCA area and 1/2 of ACA area, 1/2 of PCA area, 1/2 of cerebellar area)
- •active internal bleeding
- •Impossible to anticoagulation or anti arrhythmic drug
- •Valvular AF (MA> GII, Mechanical valve, Mitral valve replacement)
- •LV ejection fraction < 30%
- •Structural cardiac disease
- •Catheter ablation history for AF, Cardiac surgery
- •Already prescribed anti arrhythmic drugs
- •With severe medical disease
- •Expected survival < 1year
- •Severe alcoholics, drug addiction
- •14. Contraindication to MRI
研究组 & 干预措施
Rhythm control group
- Start AAD right after evaluating for LA size, EF, LA thrombus, and presence of CAD during anticoagulation
- Cardioversion after 1 month
- Rhythm FU schedule (2012 ACC/AHA/ESC guidelines)
- If AF recur, RFCA
干预措施: Rhythm control (Procedure)
Rate control group
- No AAD, just anticoagulation
- HR control between 60~110bpm (with beta blocker, calcium channel blocker, digoxin)
- Without the treatment about antiarrhythmia and rhythm control, deification of rate control, the subject will be drop out for study.
干预措施: Rate control (Procedure)
结局指标
主要结局
acute stroke with AF
时间窗: 1 year
Long term outcome of rhythm control in patients with acute stroke with AF related to all cause morality, hospital admission, recurrence rate of stroke, major adverse cardiac events
recurrence of silence stroke
时间窗: 1 year
Adverse events after anticoagulation or anti arrhythmic drug, recurrence rate after RFCA on AF in patients with stroke, adverse events after RFCA, recurrence rate of silence stroke or clinical stroke
recurrence of AF after rhythm control
时间窗: 1 year
Adverse events after anticoagulation or anti arrhythmic drug, recurrence rate after RFCA on AF in patients with stroke, adverse events after RFCA, recurrence rate of silence stroke or clinical stroke
次要结局
未报告次要终点