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

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Terminated; Phase 3

Conditions: Ischemic Heart Disease; Atrial Fibrillation

Treatments: Drug: Intralipid; Drug: Omega-3 fish oil emulsion (Omegaven)

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01175330

MCAFS-042

FAFPAF-042

Details and patient eligibility

About

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

Enrollment: 39 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 2 patient groups, including a placebo group

CABG and intralipid infusion

Placebo Comparator group

Description:

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)

Treatment:

Drug: Intralipid

CABG and omega-3 fatty acid infusion

Active Comparator group

Description:

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)

Treatment:

Drug: Omega-3 fish oil emulsion (Omegaven)