Coronary Artery DiseaseNCT00454493
The Effect of Fish Oil Supplementation on Endothelial Function, Heart Rate Variability and Intimal Media Thickness of Patients With Coronary Artery Disease
A study testing Omacor (omega-3-acid ethyl esters) in people with Coronary Artery Disease, run by Olive View-UCLA Education & Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether there is a difference in endothelial function, heart rate variability and carotid intimal media thickness in patients with coronary artery disease who are receiving fish oil therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Omacor (omega-3-acid ethyl esters)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Dec 2008
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established coronary artery disease as determined by coronary angiography within the last 5 years demonstrating at least 50% stenosis in one of the major coronary vessels
- Age >18 and <75.
Who cannot join
- Baseline fish oil intake ≥1g/day or fish intake >100g/day
- Need for urgent or emergent CABG
- Contraindication for plavix, aspirin or statin
- Gastrointestinal malabsorption syndrome
- Pregnancy
- Oral contraceptive use
Show all 9Show fewer
- Ejection fraction <40%
- Underlying atrial or ventricular arrhythmia
- History of rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate whether there is a difference in endothelial function, heart rate variability and carotid intimal media thickness in patients with coronary artery disease who are receiving fish oil therapy.
One hundred patients with established coronary artery disease by coronary angiography will undergo randomization for enrollment in the study. Baseline evaluation will include assessment of brachial artery endothelial function, heart rate variability and carotid intimal media thickness. Evaluation of the endothelial function of the brachial artery will be elucidated by inflation of a blood pressure cuff around the arm for five minutes and measuring blood vessel dynamics after release of the cuff. Heart rate variability will be evaluated by 24 hour holter monitoring and analysis by standard protocol. Carotid intimal media thickness will be evaluated by ultrasound measurements guided by predetermined protocol. Patients will then be randomized to a highly purified fish oil, Omacor, 1 gram twice a day or placebo. Brachial artery ultrasound and holter monitoring will be repeated at 2 months. Carotid ultrasound will be repeated at the end of the study at 12 months.
- Conditions
- Coronary Artery Disease
- Being tested
- Omacor (omega-3-acid ethyl esters)
- Keywords
- omacor, fish oil, omega 3, fatty acids, coronary artery disease, endothelial function, heart rate variability, carotid intimal media thickness, QT dispersion
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omacor (omega-3-acid ethyl esters)Drug
| Study group | Role | What they receive |
|---|---|---|
| fish oil | Active comparator | Not described Receives: Drug: Omacor (omega-3-acid ethyl esters) |
| placebo | Placebo comparator | Not described Receives: Drug: Omacor (omega-3-acid ethyl esters) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in flow-mediated vasodilation by brachial artery ultrasound at 2 months
Percent change in flow-mediated vasodilation by brachial artery ultrasound
Measured: 2 months
Change in heart rate variability indices at 2 months
Change in heart rate variability indices on holter monitor
Measured: 2 months
Percent change in carotid intimal media thickness at 12 months
Percent change in carotid intimal media thickness on ultrasound
Measured: 2 months
Secondary outcomes (1)
Change in QT dispersion interval at 2 months
Change in QT dispersion interval on holter monitor
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2007 (estimated)
- Study startAug 2006
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, placebo-controlled, randomized, double-blind trial
- Masking
- Double blind
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olive View-UCLA Education & Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Reliant Pharmaceuticals
- Responsible party
- Principal investigator, Sheba Meymandi, University of California, Los Angeles
- Investigators
- Sheba K Meymandi, M.D., FACC, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454493
- Sponsor's protocol ID
- 05H-561610
- Status last verified
- Mar 2007
- First submitted
- 29 Mar 2007
- Last updated
- 13 Mar 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fish Oil Supplementation on Endothelial Function, Heart Rate Variability and Intimal Media Thickness of Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00454493
- Acronym / sponsor ID
- 05H-561610
- Conditions
- Coronary Artery Disease
- Keywords
- omacor, fish oil, omega 3, fatty acids, coronary artery disease, endothelial function, heart rate variability, carotid intimal media thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Olive View-UCLA Education & Research InstituteUniversity, hospital or other
- Collaborators
- Reliant Pharmaceuticals
- Study start
- Aug 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 30 Mar 2007 (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 investigate whether there is a difference in endothelial function, heart rate variability and carotid intimal media thickness in patients with coronary artery disease who are receiving fish oil therapy.
One hundred patients with established coronary artery disease by coronary angiography will undergo randomization for enrollment in the study. Baseline evaluation will include assessment of brachial artery endothelial function, heart rate variability and carotid intimal media thickness. Evaluation of the endothelial function of the brachial artery will be elucidated by inflation of a blood pressure cuff around the arm for five minutes and measuring blood vessel dynamics after release of the cuff. Heart rate variability will be evaluated by 24 hour holter monitoring and analysis by standard protocol. Carotid intimal media thickness will be evaluated by ultrasound measurements guided by predetermined protocol. Patients will then be randomized to a highly purified fish oil, Omacor, 1 gram twice a day or placebo. Brachial artery ultrasound and holter monitoring will be repeated at 2 months. Carotid ultrasound will be repeated at the end of the study at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
- Model description
- prospective, placebo-controlled, randomized, double-blind trial
| Arm | Type | Receives |
|---|---|---|
| fish oil | Active comparator | Drug: Omacor (omega-3-acid ethyl esters) |
| placebo | Placebo comparator | Drug: Omacor (omega-3-acid ethyl esters) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Established coronary artery disease as determined by coronary angiography within the last 5 years demonstrating at least 50% stenosis in one of the major coronary vessels
- Age >18 and <75.
Key exclusion criteria (9 listed)
- Baseline fish oil intake ≥1g/day or fish intake >100g/day
- Need for urgent or emergent CABG
- Contraindication for plavix, aspirin or statin
- Gastrointestinal malabsorption syndrome
- Pregnancy
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 |
|---|---|---|
| Omacor (omega-3-acid ethyl esters) | Drug | fish oil, placebo |
Primary outcome
Percent change in flow-mediated vasodilation by brachial artery ultrasound at 2 months
Time frame: 2 months
Percent change in flow-mediated vasodilation by brachial artery ultrasound
Change in heart rate variability indices at 2 months
Time frame: 2 months
Change in heart rate variability indices on holter monitor
Percent change in carotid intimal media thickness at 12 months
Time frame: 2 months
Percent change in carotid intimal media thickness on ultrasound
1 secondary outcome
Change in QT dispersion interval at 2 months
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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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.
Sheba K Meymandi, M.D., FACC principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omacor (omega-3-acid ethyl esters) in people with Coronary Artery Disease, run by Olive View-UCLA Education & Research Institute at 1 site in United States.
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 9 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: finished, as of the sponsor's last update on 13 Mar 2019. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent change in flow-mediated vasodilation by brachial artery ultrasound at 2 months (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2019.