Omega 3 Fatty Acid Efficiency for Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting

Phase 3

Terminated

• Conditions: Atrial Fibrillation; Ischemic Heart Disease
• Interventions: Drug: Omega-3 fish oil emulsion (Omegaven); Drug: Intralipid

• Registration Number: NCT01175330
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

The purpose of this study is to evaluate efficacy of Polyunsaturated Fatty Acid for the prevention of Atrial Fibrillation and anti-inflammatory effects in patients after CABG surgery

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-03
• Study First Submitted QC: 2010-08-03
• Study First Posted: 2010-08-04
• Primary Completion: 2012-12
• Study Completion: 2013-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Elective CABG surgery.
• Signed, documented informed consent prior to admission to the study.

Exclusion Criteria

• Unstable angina, requiring intervention or CABG <24 hrs after screening.
• Decompensated congestive heart failure.
• Chronic, persistent, paroxysmal atrial fibrillation.
• Uncorrected significant valvular heart disease
• Known hypersensitivity to the study drug
• Left ventricular dysfunction (ejection fraction <35%)
• Use of anti-arrhythmic drugs other than beta blockers
• Non-cardiac illness with a life expectancy of less than 1 year
• Bleeding diathesis or history of coagulopathy
• Significant renal and liver insufficiency
• Significant thyroid, pulmonary disease
• Uncontrolled diabetes mellitus
• Patients on anti-arrhythmic drugs
• Patients with pacemaker
• Patients unable to provide/sign informed consent.
• Patients currently taking marine based omega-three fish oil supplements.
• Disturbances in lipid metabolism, serum triglyceride value >3 mmol/l

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CABG and omega-3 fatty acid infusion	Omega-3 fish oil emulsion (Omegaven)	Procedure: CABG surgery and subcutaneous cardiac monitor implantation Drug: Omegaven Lipid emulsion (omegaven) for intravenous use, 1 ml/kg/day daily for 7 days post-surgery period (The first infusion beginning in operative period)
CABG and intralipid infusion	Intralipid	Procedure: CABG surgery and subcutaneous cardiac monitor implantation Drug: Intralipid Lipid emulsion (Intralipid) for intravenous use, 1 ml/kg/day daily for 7 days post-surgery period (The first infusion beginning in operative period)

Primary Outcome Measures

Name	Time	Method
Freedom of Atrial Fibrillation or other atrial arrhythmias	2 years

Secondary Outcome Measures

Name	Time	Method
All cause mortality	3 years

Trial Locations

Locations (1)

State Research Institute of Circulation Patholody; 🇷🇺 Novosibirsk, Russian Federation