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

Atrial Fibrillation Clinical Trial

Official title:

Randomized Trial of Fish Oil Infusion to Prevent Atrial Fibrillation After Cardiac Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01175330
• Other study ID #: FAFPAF-042
• Secondary ID: MCAFS-042
• Status: Terminated
• Phase: Phase 3
• First received: August 3, 2010
• Last updated: March 23, 2015
• Start date: August 2010
• Est. completion date: August 2013

Study information

• Verified date: March 2015
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: August 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• Omega-3 fish oil emulsion (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)
• 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)

Locations

Country	Name	City	State
Russian Federation	State Research Institute of Circulation Patholody	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

Lomivorotov VV, Efremov SM, Pokushalov EA, Romanov AB, Ponomarev DN, Cherniavsky AM, Shilova AN, Karaskov AM, Lomivorotov VN. Randomized trial of fish oil infusion to prevent atrial fibrillation after cardiac surgery: data from an implantable continuous c — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom of Atrial Fibrillation or other atrial arrhythmias		2 years	Yes
Secondary	All cause mortality		3 years	Yes

External Links

•   Link