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

Phase 3TerminatedNCT01175330

Meshalkin Research Institute of Pathology of Circulation39 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Ischemic Heart Disease Atrial Fibrillation

Interventions

Omega-3 fish oil emulsion (Omegaven)DRUG

Lipid emulsion (omegaven) for intravenous use, 1 ml/kg/day daily for 7 days post-surgery period (The first infusion beginning in operative period)

IntralipidDRUG

Lipid emulsion (Intralipid) for intravenous use, 1 ml/kg/day daily for 7 days post-surgery period (The first infusion beginning in operative period)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

State Research Institute of Circulation Patholody

Novosibirsk, Russia

Outcomes

Primary Outcomes

Freedom of Atrial Fibrillation or other atrial arrhythmias

Time frame: 2 years

Secondary Outcomes

All cause mortality

Time frame: 3 years

Data from ClinicalTrials.gov

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