Comparison of Intravenous Amiodarone Versus Intravenous Procainamide for the Acute Treatment of Regular and Haemodynamically Well Tolerated Wide QRS Tachycardia (Probably of Ventricular Origen). The PROCAMIO Multicenter Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 302
- 试验地点
- 29
- 主要终点
- To compare clinically significant cardiac adverse events occurring within 40 minutes from treatment initiation
研究概览
简要总结
The purpose of this study is to determine whether intravenous amiodarone has less cardiac significant adverse events compared to intravenous procainamide in the acute treatment of haemodynamically well tolerated wide QRS tachycardia, the majority of them of probably ventricular origen.
详细描述
Multicenter, prospective and randomized study in phase IV. A total of 302 patients will be included in the study within 40-50 institutions in Spain. Patients with regular and monomorphic tachycardia ≥ 120 bpm, QRS ≥ 120 ms and haemodynamically well tolerated will be randomized to receive iv amiodarone (single dosage: 5 mg/kg in 20 minutes) vs iv procainamide (single dosage: 10 mg/kg in 20 minutes). The study period will be 40 minutes from infusion initiation. Study variables include the presence of clinically cardiac significant adverse events: hypotension, syncope, heart failure, symptomatic sinus bradycardia, AV block, proarrhythmia and tachycardia acceleration (<20 lpm)and death. Total observation period will be 24 hours after the end of the infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patients with stable tachycardia ≥120 lpm, QRS ≥120 ms and haemodynamically well tolerated defined as: 1)Systolic blood pressure ≥90 mmHg, 2) absence of dyspnea at rest, 3)absence of peripheric hypoperfusion signs and 4)no severe angina.
- •Age > 18 years
- •Written inform consent obtained
排除标准
- •Treatment with iv amiodarone or iv procainamide during the previous 24 hours
- •QRS tachycardia <120 ms
- •Patients with QRS ≥120 ms tachycardia with haemodynamic compromise that requires urgent cardioversion for termination
- •Irregular tachycardia
- •Tachycardia that is considered as supraventricular due to physician criteria (adenosine and/or vagal manoeuvres response)
- •Patient that do not want to cooperate
研究组 & 干预措施
Group 1
IV procainamide (single dose: 10 mg/kg over 20 min)
干预措施: iv Procainamide (Drug)
Group 2
IV Amiodarone (single dose: 5 mg/kg over 20 min)
干预措施: iv Amiodarone (Drug)
结局指标
主要结局
To compare clinically significant cardiac adverse events occurring within 40 minutes from treatment initiation
时间窗: 40 minutes
次要结局
- To compare efficacy of both therapies in relation to episode termination(40 minuutes)
- To compare the rate of total adverse events, cardiac and non cardiac, occurring during an observation period of 24 hours after treatment was applied(24 hours)