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

This study is currently recruiting participants.

Verified April 2012 by Meshalkin Research Institute of Pathology of Circulation

First Received on August 3, 2010. Last Updated on April 24, 2012 History of Changes

Sponsor:	Meshalkin Research Institute of Pathology of Circulation
Information provided by (Responsible Party):	Efremov Sergey, Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:	NCT01175330

Purpose

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

Condition	Intervention	Phase
Ischemic Heart Disease Atrial Fibrillation	Drug: Omega-3 fish oil emulsion (Omegaven) Drug: Intralipid	Phase 3

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

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Coronary Artery Bypass Surgery Coronary Artery Disease Heart Diseases

Drug Information available for: Liposyn II Liposyn III

U.S. FDA Resources

Further study details as provided by Meshalkin Research Institute of Pathology of Circulation:

Primary Outcome Measures:

Freedom of Atrial Fibrillation or other atrial arrhythmias [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

All cause mortality [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	August 2010
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175330

Contacts

Contact: Alexander Cherniavskiy, MD, PhD, Prof.	+7 383 3322655	amchern@mail.ru
Contact: Alexander Romanov, MD, PhD	+7 383 33227655	abromanov@mail.ru

Locations

Russian Federation
State Research Institute of Circulation Patholody	Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Alexander Cherniavskiy, MD, PhD, Prof. +73833322655 amchern@mail.ru
Contact: Alexander Romanov, MD, PhD +73833327655 abromanov@mail.ru
Principal Investigator: Alexander Cherniavskiy, MD,PhD, Prof.
Sub-Investigator: Evgeny Pokushalov, MD, PhD
Sub-Investigator: Vladimir Lomivorotov, MD,PhD
Sub-Investigator: Alexander Romanov, MD, PhD

Sponsors and Collaborators

Meshalkin Research Institute of Pathology of Circulation

More Information

No publications provided

Responsible Party:	Efremov Sergey, Anesthesist, Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:	NCT01175330 History of Changes
Other Study ID Numbers:	FAFPAF-042, MCAFS-042
Study First Received:	August 3, 2010
Last Updated:	April 24, 2012
Health Authority:	Russia: Ethics Committee

Keywords provided by Meshalkin Research Institute of Pathology of Circulation:

Omega-3 fatty acid
Ischemic Heart Disease
Atrial Fibrillation
Subcutaneous cardiac monitoring

Additional relevant MeSH terms:

Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Arrhythmias, Cardiac

Cardiovascular Diseases
Pathologic Processes
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2012