Omega-3 fatty acids for Prevention of post-opERative Atrial fibrillation (OPERA) - OPERA

Conditions: Patients scheduled for cardiac surgery
MedDRA version: 9.1Level: SOCClassification code 10007541

Registration Number: EUCTR2009-017582-29-IT

Lead Sponsor: CONSORZIO MARIO NEGRI SUD

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1516

Inclusion Criteria

Age 18+ years of age. 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, ectopy and history of AF are acceptable).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Regular use (3 or more days/week) of fish oil within the past 4 weeks. Known allergy or intolerance to omega-3 or olive oil. Currently pregnant. Unable to provide informed written consent.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether peri-operative administration of omega-3 reduces occurrence of atrial fibrillation or flutter (AF) in patients undergoing cardiac surgery compared to placebo;Secondary Objective: To determine if omega-3 treatment reduces resource utilization as assessed by coronary care unit, telemetry, and total hospital lengths-of-stay. To determine genetic, biologic, autonomic, and electrophysiologic mediators and pathways of effects of omega-3 on cardiac arrhythmia.;Primary end point(s): To determine whether peri-operative administration of omega-3 reduces the occurrence of post- cardiac surgery AF (Fibrillation/Flutter) of at least 30 seconds duration and confirmed by rhythm strip or 12-lead ECG compared to placebo

Secondary Outcome Measures