Status:
TERMINATED
Omega 3 Fatty Acid Efficiency for Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting
Lead Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Conditions:
Ischemic Heart Disease
Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- Elective CABG surgery.
- Signed, documented informed consent prior to admission to the study.
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01175330
Start Date
August 1 2010
End Date
August 1 2013
Last Update
March 24 2015
Active Locations (1)
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1
State Research Institute of Circulation Patholody
Novosibirsk, Russia, 630055