Ischemic Heart DiseasePhase 3NCT01175330
Omega 3 Fatty Acid Efficiency for Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting
A Phase 3 study testing Omega-3 fish oil emulsion (Omegaven) and Intralipid in people with Ischemic Heart Disease and Atrial Fibrillation, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Heart Disease, Atrial Fibrillation
- What is being tested?
- Omega-3 fish oil emulsion (Omegaven) and Intralipid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteRussia
- Study dates
- Aug 2010to Aug 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective CABG surgery.
- Signed, documented informed consent prior to admission to the study.
Who cannot join
- 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%)
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- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
State Research Institute of Circulation Patholody
Novosibirsk, 630055
About this study
Official title: 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
- Conditions
- Ischemic Heart Disease, Atrial Fibrillation
- Being tested
- Omega-3 fish oil emulsion (Omegaven), Intralipid
- Keywords
- Omega-3 fatty acid, Ischemic Heart Disease, Atrial Fibrillation, Subcutaneous cardiac monitoring
- Medical subject headings
- Myocardial Ischemia, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Omega-3 fish oil emulsion (Omegaven) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom of Atrial Fibrillation or other atrial arrhythmias
Measured: 2 years
Secondary outcomes (1)
All cause mortality
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2012
- Study completionAug 2013
Why it stopped: Interim analysis did not reveal of anticipated benefits of intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Efremov Sergey, Meshalkin Research Institute of Pathology of Circulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175330
- Sponsor's protocol ID
- FAFPAF-042
- Other IDs
- MCAFS-042
- Status last verified
- Mar 2015
- First submitted
- 3 Aug 2010
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25027101
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Fish Oil Infusion to Prevent Atrial Fibrillation After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01175330
- Acronym / sponsor ID
- FAFPAF-042
- Conditions
- Ischemic Heart Disease, Atrial Fibrillation
- Keywords
- Omega-3 fatty acid, Ischemic Heart Disease, Atrial Fibrillation, Subcutaneous cardiac monitoring
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis did not reveal of anticipated benefits of intervention
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Aug 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 4 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CABG and intralipid infusion | Placebo comparator | Drug: IntralipidProcedure: 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) |
| CABG and omega-3 fatty acid infusion | Active comparator | Drug: Omega-3 fish oil emulsion (Omegaven)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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective CABG surgery.
- Signed, documented informed consent prior to admission to the study.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | CABG and omega-3 fatty acid infusion |
| IntralipidLipid emulsion (Intralipid) for intravenous use, 1 ml/kg/day daily for 7 days post-surgery period (The first infusion beginning in operative period) | Drug | CABG and intralipid infusion |
Primary outcome
Freedom of Atrial Fibrillation or other atrial arrhythmias
Time frame: 2 years
1 secondary outcome
All cause mortality
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Interim analysis did not reveal of anticipated benefits of intervention). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
- Results publication: PubMed 25027101Lomivorotov 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omega-3 fish oil emulsion (Omegaven) and Intralipid in people with Ischemic Heart Disease and Atrial Fibrillation, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Interim analysis did not reveal of anticipated benefits of intervention). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom of Atrial Fibrillation or other atrial arrhythmias (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01175330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.