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

March 23, 2015 updated by: Efremov Sergey, Meshalkin Research Institute of Pathology of Circulation

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation, 630055
        • State Research Institute of Circulation Patholody

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: CABG and intralipid infusion
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)
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)
Active Comparator: CABG and omega-3 fatty acid infusion
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)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom of Atrial Fibrillation or other atrial arrhythmias
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

August 3, 2010

First Submitted That Met QC Criteria

August 3, 2010

First Posted (Estimate)

August 4, 2010

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 23, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAFPAF-042
  • MCAFS-042

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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