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

This study has been terminated.
(Interim analysis did not reveal of anticipated benefits of intervention)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01175330
First Posted: August 4, 2010
Last Update Posted: March 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Efremov Sergey, Meshalkin Research Institute of Pathology of Circulation
August 3, 2010
August 4, 2010
March 24, 2015
August 2010
December 2012   (Final data collection date for primary outcome measure)
Freedom of Atrial Fibrillation or other atrial arrhythmias [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT01175330 on ClinicalTrials.gov Archive Site
All cause mortality [ Time Frame: 3 years ]
Same as current
Not Provided
Not Provided
 
Omega 3 Fatty Acid Efficiency for Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
  • Ischemic Heart Disease
  • Atrial Fibrillation
  • 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)
  • 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)
  • 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)
    Intervention: Drug: Intralipid
  • 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)
    Intervention: Drug: Omega-3 fish oil emulsion (Omegaven)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
39
August 2013
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
 
NCT01175330
FAFPAF-042
MCAFS-042
Yes
Not Provided
Not Provided
Efremov Sergey, Meshalkin Research Institute of Pathology of Circulation
Meshalkin Research Institute of Pathology of Circulation
Not Provided
Not Provided
Meshalkin Research Institute of Pathology of Circulation
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP