Status:
COMPLETED
Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
The OPERA Investigators
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a large multi-center study to examine whether peri-operative intake of n-3 polyunsaturated fatty acids (PUFA) will reduce the occurrence of post-operative atrial fibrillation or flutter (AF) i...
Eligibility Criteria
Inclusion
- Age 18 years or over
- Scheduled for CS on the following day or later, including coronary artery bypass, valve surgery, any other open cardiac surgery (i.e., that includes opening of the pericardium), or any combination.
- Sinus rhythm on current ECG (sinus bradycardia, sinus tachycardia, and ectopy are acceptable).
Exclusion
- Regular use (3 or more days/week) of fish oil within the past 4 weeks.
- Known allergy or intolerance to fish oil or corn oil.
- Currently pregnant.
- Unable to provide informed written consent.
- Current or planned cardiac transplant or LVAD
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
1516 Patients enrolled
Trial Details
Trial ID
NCT00970489
Start Date
August 1 2010
End Date
June 1 2012
Last Update
April 10 2017
Active Locations (1)
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1
US, Italy and Argentina
Boston, Massachusetts, United States, 02115