1. Measurement of the hsTnT value in patients undergoing elective ECV in order to determine AMI.2. Identification of characteristics related to an minimal increase of hsTnT value (
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Acuut myocardialinfarction is proved by a high-sensitive Troponin T value of
above 50 ng/L or above 14 ng/L combined with an increase of hsTnT for at least
with 7 ng/L within 2 hours in patients undergoing an elective cardioversion for
atrial tachyarrhythmias.
Secondary outcome
Identification of characteristics related to a minimal increase of hsTnT value
(<14 ng/L).
Background summary
The measurement of cardiac troponins, biomarker, in patients suspected of an
acute myocardial infarction (AMI) is a standard technique. High-sensitive
troponins (hsTnT) are the most recent biomarker of AMI, which is included in
the guidelines. Electric cardioversion (ECV) might cause myocardial damage. It
is unknown whether the damage creates an AMI. Prior troponins studies couldn*t
determine AMI. HsTnT might be able to detect AMI after ECV.
Study objective
1. Measurement of the hsTnT value in patients undergoing elective ECV in order
to determine AMI.
2. Identification of characteristics related to an minimal increase of hsTnT
value (<14 ng/L).
Study design
Inclusion of patients with an atrial tachyarrhythmia requiring elective
electric cardioversion at the cardiology department. Prior ECV blood samples
are collected, extra study blood samples (hsTnT and CK) will be collected. Two
and four hours after ECV study blood samples will be collected. During
hospitalization heart rhythm will be monitored continuously. In case of
significant elevated hsTnT levels the study protocol will be switched to the
standard AMI protocol. In all other cases the patient will be discharged after
four hours. An appointment for the next day at the outpatients clinic will be
made in order to asses an electrocardiogram and the last study blood samples.
Clinical data will be obtained from electronic patients files.
Three months after the ECV the electronic patients files will be consulted in
order to define any incidence of AMI in past three months.
Study burden and risks
Patient*s hospitalization will be prolonged by one hour with continuous rhythm
monitoring. During vena punction extra blood will be taken and 3 times an extra
vena punction will take place. The vena punction can be complicated with a
local hematoma.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
1. Atrial arrhythmias requiring electric cardioversion in an elective setting
2. Competent adults
3. Patients 18 year old or >18 years
Exclusion criteria
1. Electric cardioversion in an emergency setting
2. Incompetent adults
3 Patients <18 year old
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43530.078.13 |