NCT05666219撤回4 期
Assessing the Impact of Aminophylline in the Reversal of Complete Heart Block Secondary to Inferior Wall MI in Atropine Resistant Patients: An Open Label Non-randomized Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 73
- 主要终点
- Reversal of complete heart block
研究概览
简要总结
In this study, the investigator will evaluate the rate of reversal of complete heart block with aminophylline in atropine resistant patients with inferior wall myocardial infarction (MI)
详细描述
Administration of Aminophylline can result in reversal of complete heart block in a significant number of atropine resistant patients with inferior wall MI. Hence, in this study our primary aim is to evaluate the rate of reversal of complete heart block with aminophylline in atropine resistant patients with inferior wall MI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Adult patients admitted with recent acute inferior wall myocardial infarction (MI)
- •Hemodynamically stable blood pressure
- •Complete heart block with Narrow QRS < 120 ms and ventricular rate >40/min persisting for at least 6 hours, resistant to atropine
- •Temporary pacemaker (TPM) already placed
- •Patient asymptomatic with a mean arterial pressure of greater than 65 mmHg with TPM rate placed at 40/min
排除标准
- •Patients with cardiogenic shock
- •Patients with preexisting permanent pacemaker and Implantable Cardioverter Defibrillator (ICD).
- •Patients with a prior history of AV block
- •Drugs with dromotropic effects (beta blocker, calcium channel blocker, inotropes)
- •Known liver disease (cirrhosis, hepatitis)
- •Hypothyroidism
- •Unable to consent
研究组 & 干预措施
Treatment group
Experimental
Patients receiving Injection Aminophylline
干预措施: Aminophylline Injection (Drug)
结局指标
主要结局
Reversal of complete heart block
时间窗: Within 1 hour of 2nd dose
Conversion to sinus rhythm with 1:1 conduction
次要结局
- Improved conduction(Within 1 hour of 2nd dose)
- Major adverse cardiac events (MACE)(Within 12 hours)
研究者
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