Myocardial Injury Following Elective Direct Current Cardioversion for Atrial Arrhythmias

Completed

• Conditions: Cardioversion
• Interventions: Diagnostic Test: Blood sample collection

• Registration Number: NCT04151966
• Lead Sponsor: Mayo Clinic

Brief Summary

Researchers are trying to determine if heart injury occurs in subjects who undergo direct current cardioversion.

Detailed Description

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.

Study Timeline

• Study Start: 2019-07-22
• Study First Submitted: 2019-11-02
• Study First Submitted QC: 2019-11-02
• Study First Posted: 2019-11-05
• Primary Completion: 2020-06-05
• Study Completion: 2021-12-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-04
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• Patients who are undergoing elective direct current cardioversion, either externally or via the patient's internal cardioverter-defibrillator

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardioversion Group	Blood sample collection	Subjects scheduled to undergo direct current cardioversion (DCCV) as part of the clinical plan of care

Primary Outcome Measures

Name	Time	Method
Myocardial injury	Baseline, 6-24 hours post procedure	Changes in high sensitivity cardiac troponin T (hs-cTnT) or troponin I (hs-cTnI) assay

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States