Use of Adenosine to Determine the Electrophysiological Mechanism of Premature Ventricular Contractions
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Effects of Adenosine on premature ventricular contractions (PVCs) as measured by EKG;
研究概览
简要总结
Unblinded, controlled, non-randomized, mechanistic study to determine whether physiological mechanisms underlying PVC are sensitive to adenosine. One hundred subjects undergoing clinically-indicated, standard-of-care cardiac electrophysiology study (EPS) procedure for PVCs will receive adenosine and/or verapamil to learn if their arrhythmias are inducible similarly to sustained ventricular tachycardia.
详细描述
The cellular mechanism of premature ventricular contractions (PVCs) is unknown. The investigators have previously observed that 5% of patients in the investigators electrophysiology laboratory with ventricular outflow tract PVCs have inducible sustained ventricular tachycardia (VT) that behaves in a manner similar to patients who present clinically with sustained ventricular tachycardia, i.e., sensitive to adenosine and triggered activity. This suggests that outflow arrhythmias may be a continuum of a single mechanism.
Adenosine is known to terminate ventricular arrhythmias that are due to triggered activity (ref Lerman). To study the effects of adenosine on PVC, the investigators will administer Verapamil to slow down the heart initially and adenosine after catheters are introduced to patients who are being treated for symptomatic PVC and have consented to treatment with an invasive electrophysiology study and catheter ablation. The investigators will observe if there is any effect of reduced PVC following adenosine administration.
The investigators hypothesize that PVC will be suppressed by exogenous adenosine and/or verapamil. The information from this study will elucidate the underlying cellular mechanism of this common arrhythmia. Such knowledge could potentially lead to developing therapeutic targets. Moreover, it will have potential clinical applications for inducing outflow tract PVCs/VT in patients whose arrhythmia is suppressed at the time of their invasive electrophysiology study.
Analysis of the Holter recording of premature ventricular contractions:
Analysis of the PVC coupling intervals can be helpful for delineating the mechanism of PVCs. Holter monitors are being obtained on these patients prior to ablation as part of standard of care. Holters monitors, if performed at our institution, will be analyzed in detail in a retrospective fashion. Holter reports from 1/1/2015 - 5/15/2019 will be reviewed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of premature ventricular contractions (PVCs)
- •Scheduled to undergo an electrophysiology study with the intention of performing cardiac ablation for the treatment of PVCs
- •Male or female between the ages of 18 and 70 years
- •Capable of giving informed consent
排除标准
- •Any structural heart disease
- •Coronary artery disease (≥ 70% stenosis)
- •Current treatment with anti-arrhythmic drugs
- •Asthma (if administering adenosine)
研究组 & 干预措施
Adenosine/ Verapamil Arm
Adenosine: 0.84 mg/kg IV (140 mcg/kg/minute IV for 6 minutes) Verapamil: 0.15 mg/kg IV
Adenosine is known to terminate ventricular arrhythmias that are due to triggered activity (ref Lerman). To study the effects of adenosine on PVC, the investigators will administer Verapamil to slow down the heart initially and adenosine after catheters are introduced to patients who are being treated for symptomatic PVC and have consented to treatment with an invasive electrophysiology study and catheter ablation.
干预措施: Adenosine (Drug)
结局指标
主要结局
Effects of Adenosine on premature ventricular contractions (PVCs) as measured by EKG;
时间窗: baseline
The metrics that will be collected will be: * Baseline frequency of premature ventricular contractions (PVCs) * Frequency of premature ventricular contractions (PVCs) during adenosine administration
Effects of verapamil on premature ventricular contractions (PVCs) as measured by EKGs.
时间窗: baseline
The metrics that will be collected will be: * Baseline frequency of premature ventricular contractions (PVCs) * Frequency of premature ventricular contractions (PVCs) during verapamil administration
次要结局
未报告次要终点