Comparison of the Clinical Utility of Atropine and Isoprenaline in the Invasive Diagnosis of Arrhythmias
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Evaluation of anterograde atrioventricular conduction
研究概览
简要总结
During electrophysiological study (EPS) multiple drugs are used to reveal arrhythmias and/or conductive system disorders. Two most often used agents are atropine and isoprenaline. Due to their distinct pharmacological properties, they are affecting myocardium in different manner. Those dissimilarities can affect the EPS course and long-term prognosis. The aim of presented study is to evaluate the optimal protocol of pharmacotherapy during EPS.
详细描述
Electrophysiological study (EPS) is essential tool for heart rhythm disorders diagnostic. Inducibility of arrhythmia before ablation to confirm the diagnosis and inability to do so after the procedure is crucial for long-term success. Multiple drugs are used to reveal arrhythmias and/or conductive system disorders. Two most often used are atropine and isoprenaline. Atropine is a natural, selective antagonist of cholinergic receptors M1 and M2. It reverses the inhibitory effect of vagal nerve on myocardium. This improves sinus node automatism and conduction in atrioventricular node. Isoprenaline is a preferential agonist of beta-1-adrenergic receptors. It has bathmotropic and chronotropic effect. During daily clinical practice those two drugs are often used interchangeably. However, differences in pharmacokinetics and pharmacodynamics may affect the results. There are lack of data directly comparing those two agents. There are isolated evidences that arrhythmia inducibility rate after the ablation differs between those two drugs. This may lead to the misconception of ablation as successful. The aim of presented study is to evaluate the optimal protocol of pharmacotherapy during EPS.
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
- Single (Participant)
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
- •Patients with indication for electrophysiological study according to present guidelines of European Society of Cardiology
排除标准
- •Not willing or incapable to give written informed consent.
- •Previous diagnosed ventricle tachycardia or fibrillation
- •Previous diagnosed atrial fibrillation or flutter
- •Glaucoma (contraindication for atropine)
研究组 & 干预措施
Atropine
Patients in whom during electrophysiological study atropine will be used. I.v. bolus of 0.01 mg/kg b.w. will be administered to reach the increase of heart rate of 25% or up to 130/min. If necessary, dose will be increased every 5 minutes until mention above parameters are achieved. Maximum dose will be 0.4 mg/kg b.w.
干预措施: Comparison of atropine and isoprenaline (Drug)
Isoprenaline
Patients in whom during electrophysiological study isoprenaline will be used. Continuous i.v. infusion of 0.01 mcg/kg b.w./min will be administered to reach the increase of heart rate of 25% or up to 130/min. If necessary, dose will be doubled every 5 minutes until mention above parameters are achieved. Maximum dose will be 20 mcg/min.
干预措施: Comparison of atropine and isoprenaline (Drug)
结局指标
主要结局
Evaluation of anterograde atrioventricular conduction
时间窗: During the procedure
Anterograde Wenkebach point (ms) and effective refractory period of atrioventricular node (ms) during programed atrial stimulation will be assessed.
Evaluation of sino-atrial conduction time
时间窗: During the procedure
Sino-atrial conduction time (ms) during programed atrial stimulation will be assessed to examine the function of sinus node.
Evaluation of sinus node recovery time
时间窗: During the procedure
Sinus node recovery time (ms) during programed atrial stimulation will be assessed to examine the function of sinus node.
Long-term success rate
时间窗: 12 months
Recurrence of clinical arrhythmia during 12 months of observation
Arrhythmia inducibility
时间窗: During the procedure
Inducibility of anticipated arrythmia before and after drug administration and after eventual ablation.
Evaluation of retrograde atrioventricular conduction
时间窗: During the procedure
Retrograde Wenkebach point (ms) and effective refractory period of atrioventricular node (ms) during programed ventricular stimulation will be assessed.
次要结局
- Incidence of adverse events during the electrophysiological study.(During the procedure)
- Length of the procedure(During the procedure)
- Incidence of adverse events during the 12-month follow up.(12 months)
- Procedure time form drug administration till the end.(During the procedure)
