Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04151966 |
| Other study ID # |
19-004287 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 22, 2019 |
| Est. completion date |
December 1, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
Mayo Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Researchers are trying to determine if heart injury occurs in subjects who undergo direct
current cardioversion.
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.
