Comparison of elective early direct current (DC) cardioversion vs oral amiodarone in the treatment for new post-operative atrial fibrillation in patients undergoing coronary artery bypass grafting (CABG): a prospective randomised controlled study
| ISRCTN | ISRCTN69583185 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69583185 |
| Protocol serial number | N0054123058 |
| Sponsor | Department of Health |
| Funder | The Cardiothoracic Centre Liverpool NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 14/11/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr W Dihmis
Scientific
Scientific
Department of Cardiac Surgery
The Cardiothoracic Centre
Liverpool NHS Trust
Thomas Drive
Liverpool
L14 3PE
United Kingdom
| Phone | +44 (0)151 228 1616 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Elective DC cardioversion is one of the modalities of treating new atrial fibrillation. The procedure is deemed relatively safe, and immediately effective in most instances. However, there have been few studies comparing the results of early elective DC cardioversion with the results of the use of anti-arrhythmic drugs only as primary modalities of treatment for this condition, and the implications this may have on the incidence of heamodynamic compromise, thrombo-embolic events and hospital stay. The results of this study will help us in making the choice about the safest, quickest and most appropriate modality of treatment for these patients, and this would have favourable implications on patient outcome and duration of hospital stay. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Atrial fibrillation (AF) |
| Intervention | First time CABG patients who develop atrial fibrillation in the post-operative period following discharge from intensive care will be randomly assigned to one of two groups. Group one will be administered oral amiodarone and group two will receive DC cardioversion in addition to oral amiodarone. Daily electrocardiogram (ECG) will document heart rhythm. A blinded independent researcher will interpret the ECG on the day of discharge. |
| Intervention type | Other |
| Primary outcome measure(s) |
Patient's cardiac rhythm at discharge |
| Key secondary outcome measure(s) |
1. Duration between onset of atrial fibrillation and reversion to sinus rhythm |
| Completion date | 01/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 400 |
| Key inclusion criteria | 400 first time CABG patients who develop atrial fibrillation in the post-operative period following discharge from intensive care will be randomly assigned to one of two groups. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 08/05/2003 |
| Date of final enrolment | 01/05/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Cardiac Surgery
Liverpool
L14 3PE
United Kingdom
L14 3PE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
