Evaluation of Potential Myocardial Injury Following Elective Direct Current Cardioversion for Atrial Arrhythmias
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Myocardial injury
研究概览
简要总结
Researchers are trying to determine if heart injury occurs in subjects who undergo direct current cardioversion.
详细描述
External transthoracic direct current (DC) cardioversion is a commonly used method of terminating cardiac arrhythmias. Conventional wisdom indicates that external DC cardioversion causes myocardial injury. Previous research has shown that DC cardioversion resulted in myocardial injury as evidenced by increased levels of cardiac troponin, even though those changes were modest. Many of these studies evaluated monophasic defibrillators and older, less sensitive cardiac troponin assays. The current standard is now to use modern biphasic defibrillators and new high sensitivity cardiac troponin assays (hs-cTnT). It is conceivable that the newer defibrillators may not cause myocardial injury. It would be important to understand if myocardial injury occurs in this setting and its approximate magnitude as it would the interpretation of hs-cTnT values in patients and therefore influenced diagnoses. It may be if a threshold energy level can be identified that is would also influence the choice of energy used to deliver the shock in this situation.
A previous preliminary study documented no evidence of myocardial injury after elective DC cardioversion with modern day defibrillators. We aim to validate and expand that study here at Mayo Clinic Rochester.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 who are undergoing elective direct current cardioversion, either externally or via the patient's internal cardioverter-defibrillator
排除标准
- •Patients under age 18
- •Patients with myocardial infarction, coronary artery bypass grafting or any invasive cardiac procedure in the previous six weeks
- •Pregnant patients
- •Patients who cannot provide informed consent because of cognitive dysfunction
结局指标
主要结局
Myocardial injury
时间窗: Baseline, 6-24 hours post procedure
Changes in high sensitivity cardiac troponin T (hs-cTnT) or troponin I (hs-cTnI) assay
次要结局
未报告次要终点
研究者
Allan S. Jaffe
Principal Investigator
Mayo Clinic
