NCT01175330

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2010

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

2.3 years

First QC Date

August 3, 2010

Last Update Submit

March 23, 2015

Conditions

Ischemic Heart DiseaseAtrial Fibrillation

Keywords

Omega-3 fatty acidIschemic Heart DiseaseAtrial FibrillationSubcutaneous cardiac monitoring

Outcome Measures

Primary Outcomes (1)

  • Freedom of Atrial Fibrillation or other atrial arrhythmias

    2 years

Secondary Outcomes (1)

  • All cause mortality

    3 years

Study Arms (2)

CABG and intralipid infusion

PLACEBO COMPARATOR

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

CABG and omega-3 fatty acid infusion

ACTIVE COMPARATOR

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)

Interventions

Omega-3 fish oil emulsion (Omegaven)DRUG

Lipid emulsion (omegaven) for intravenous use, 1 ml/kg/day daily for 7 days post-surgery period (The first infusion beginning in operative period)

CABG and omega-3 fatty acid infusion
IntralipidDRUG

Lipid emulsion (Intralipid) for intravenous use, 1 ml/kg/day daily for 7 days post-surgery period (The first infusion beginning in operative period)

CABG and intralipid infusion

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective CABG surgery.
  • Signed, documented informed consent prior to admission to the study.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Research Institute of Circulation Patholody

Novosibirsk, 630055, Russia

Location

Related 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 cardiac monitor. J Cardiothorac Vasc Anesth. 2014 Oct;28(5):1278-84. doi: 10.1053/j.jvca.2014.02.019. Epub 2014 Jul 11.

    PMID: 25027101RESULT

MeSH Terms

Conditions

Myocardial IschemiaAtrial Fibrillation

Interventions

fish oil triglyceridessoybean oil, phospholipid emulsion

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesist

Study Record Dates

First Submitted

August 3, 2010

First Posted

August 4, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2012

Study Completion

August 1, 2013

Last Updated

March 24, 2015

Record last verified: 2015-03

Locations

RU(1)