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临床试验/NCT04151966
NCT04151966已完成不适用

Evaluation of Potential Myocardial Injury Following Elective Direct Current Cardioversion for Atrial Arrhythmias

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2019年7月22日最近更新:
适应症

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

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

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Allan S. Jaffe

Principal Investigator

Mayo Clinic

研究点 (1)

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