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

Primary Purpose

Ischemic Heart Disease, Atrial Fibrillation

Status
Terminated
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Omega-3 fish oil emulsion (Omegaven)
Intralipid
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Omega-3 fatty acid, Ischemic Heart Disease, Atrial Fibrillation, Subcutaneous cardiac monitoring

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • State Research Institute of Circulation Patholody

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

CABG and intralipid infusion

CABG and omega-3 fatty acid infusion

Arm 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)

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)

Outcomes

Primary Outcome Measures

Freedom of Atrial Fibrillation or other atrial arrhythmias

Secondary Outcome Measures

All cause mortality

Full Information

First Posted
August 3, 2010
Last Updated
March 23, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT01175330
Brief Title
Omega 3 Fatty Acid Efficiency for Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting
Official Title
Randomized Trial of Fish Oil Infusion to Prevent Atrial Fibrillation After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis did not reveal of anticipated benefits of intervention
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Atrial Fibrillation
Keywords
Omega-3 fatty acid, Ischemic Heart Disease, Atrial Fibrillation, Subcutaneous cardiac monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CABG and intralipid infusion
Arm Type
Placebo Comparator
Arm 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)
Arm Title
CABG and omega-3 fatty acid infusion
Arm Type
Active Comparator
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Omega-3 fish oil emulsion (Omegaven)
Intervention Description
Lipid emulsion (omegaven) for intravenous use, 1 ml/kg/day daily for 7 days post-surgery period (The first infusion beginning in operative period)
Intervention Type
Drug
Intervention Name(s)
Intralipid
Intervention Description
Lipid emulsion (Intralipid) for intravenous use, 1 ml/kg/day daily for 7 days post-surgery period (The first infusion beginning in operative period)
Primary Outcome Measure Information:
Title
Freedom of Atrial Fibrillation or other atrial arrhythmias
Time Frame
2 years
Secondary Outcome Measure Information:
Title
All cause mortality
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
State Research Institute of Circulation Patholody
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
25027101
Citation
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 cardiac monitor. J Cardiothorac Vasc Anesth. 2014 Oct;28(5):1278-84. doi: 10.1053/j.jvca.2014.02.019. Epub 2014 Jul 11.
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Omega 3 Fatty Acid Efficiency for Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting

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