Atrial Fibrillation Clinical Trial
— CODEOfficial title:
A Comparison of Two Biphasic Waveforms and Impact of Oxygen on Myocardial Injury Following Cardioversion
NCT number | NCT02317029 |
Other study ID # | 38281 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2013 |
Est. completion date | January 2016 |
Verified date | May 2018 |
Source | Randers Regional Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background:
Cardiac arrhythmias can be terminated by electrical current applied by an external
defibrillator. This treatment, named cardioversion, has been used for decades in the
treatment of atrial fibrillation.
Several kinds of defibrillators exist, though the relative efficacy and safety of these
defibrillators is not clear.
During cardioversion, oxygen is being administered, and it has been a long-held belief that
oxygen is always beneficial for the patient. This is now being challenged by recent studies
suggesting excessive oxygenation to be potentially dangerous for the patients.
Objective:
1. To compare the efficiency and safety of two different defibrillators
2. To investigate the effects of excessive oxygen on injury of the heart following
cardioversion.
Experimental design:
Patients will be recruited at the outpatient clinic at the Department of Cardiology, Regional
Hospital of Randers, Denmark as a part of the pre-cardioversion check.
Patients will be randomized to cardioversion using one of two defibrillators and randomized
to treatment with room air or 100% oxygen.
The cardiac condition will be measured by blood samples before cardioversion, 4 hours after
cardioversion and 3 months after cardioversion. Heart rhythm will be measured by ECG before
cardioversion, 1 minute-, 30 minutes- and 4 hours after cardioversion.
Status | Terminated |
Enrollment | 134 |
Est. completion date | January 2016 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Atrial fibrillation or -flutter Exclusion Criteria: - Patients <18 years of age - Pregnancy - Haemodynamically unstable patients - Other arrhythmias - Untreated hyperthyroidism |
Country | Name | City | State |
---|---|---|---|
Denmark | Randers Regional Hospital | Randers | Midtjylland |
Lead Sponsor | Collaborator |
---|---|
Randers Regional Hospital | Aarhus University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Hs-cTnI and Hs-cTnT for room air versus hyperoxia | High sensitive cardiac Troponin I (Hs-cTnI) and -T (Hs-cTnT) are biomarkers for myocardial injury. Cardiac troponins are measured in plasma as ng/L. Change in cardiac troponins (4 hours after cardioversion - pre-cardioversion) will be compared between room air and hyperoxia. |
Change measured from 2 hours before and 4 hours after cardioversion | |
Primary | Defibrillator Efficiency: Proportion of patients in sinus rhythm four hours post cardioversion | Proportion of patients in sinus rhythm four hours post cardioversion | Heart rhythm measured four hours after cardioversion | |
Secondary | Cardiac rhythm and change in biomarkers | Biomarkers will be measured by NT-pro-BNP (ng/L) and Copeptin (pmol/L) at baseline, discharge and at a 3 months follow up visit in the outpatient Clinic. Change in biomarker levels will be compared for patients treated with hyperoxia and room air. | Biomarkers will be measured within 2 hours before, 4 hours after and 3 months after cardioversion. ECG will be recorded after 1 minute, 30 minutes and four hours after cardioversion. | |
Secondary | Echocardiography | Cardiac function will be evaluated. | Performed at baseline, 2-4 hours after and 3 months following cardioversion |
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