Comparison of Brain Perfusion in Rhythm Control and Rate Control of Persistent Atrial Fibrillation: Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- K-MOCA(Korean version of Montreal Cognitive Assessment)
研究概览
简要总结
Atrial fibrillation (AF) is associated with impaired cognitive function (CogF) and/or dementia, but it is unclear whether rhythm control of AF improves CogF or brain perfusion. The hypothesis is rhythm control of AF improves CogF by increasing brain perfusion with hemodynamic amelioration compared to AF state. We will randomize the patients with persistent AF to rhythm control group and rate control group, and check baseline and 3rd month cognitive function (K-MOCA score) and brain perfusion CT. K-MOCA score and brain perfusion CT findings will be compared between rhythm control group and rate control group of persistent AF.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with persistent Atrial fibrillation (20~80 years old)
- •LA diameter < 55mm
- •patients possible to anticoagulation and anti arrhythmic drug
排除标准
- •Structural cardiac disease
- •Contraindication to brain perfusion CT
- •Catheter ablation history for AF, Cardiac surgery
- •active internal bleeding
- •Impossible to anticoagulation or antiarrhythmic drug
- •valvular AF ((MA> GII, Mechanical valve, Mitral valve replacement)
- •LVEF < 30%
- •With severe medical disease
- •Expected survival < 1 year
- •Severe alcoholics, drug addiction
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 2. check the echo, brain perfusion CT and K-MOCA on baseline 3. confirm a thrombus through the TEE 4. Cardioversion after 1 month 5. Rhythm FU schedule (2012 ACC/AHA/ESC guidelines) 6. If AF recur, RFCA 7. check the brain perfusion CT, K-MOCA after 3M and 12M
干预措施: Propafenone (Drug)
Rate control group
- No AAD, just anticoagulation 2. HR control between 60~110bpm (with beta blocker, calcium channel blocker, digoxin) 3. check the echo, brain perfusion CT and K-MOCA on baseline 4. check the brain perfusion CT and K-MOCA after 3M and 12M 5. Without the treatment about antiarrythmia and rhythm control, diffication of rate control, the subject will be drop out for study.
干预措施: Apixaban (Drug)
结局指标
主要结局
K-MOCA(Korean version of Montreal Cognitive Assessment)
时间窗: 12 months after the enrollment
Brain perfusion CT
时间窗: 12 months after the enrollment
次要结局
未报告次要终点