Overview

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

Status:
Terminated
Trial end date:
2013-08-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Treatments:
Soybean oil, phospholipid emulsion
Criteria
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