The Effect of Fish Oil Supplementation on Endothelial Function, Heart Rate Variability and Intimal Media Thickness of Patients With Coronary Artery Disease
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omacor (omega-3-acid ethyl esters)
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring omacor, fish oil, omega 3, fatty acids, coronary artery disease, endothelial function, heart rate variability, carotid intimal media thickness, QT dispersion
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Ejection fraction <40%
- Underlying atrial or ventricular arrhythmia
- History of rheumatoid arthritis
Sites / Locations
- OV-UCLA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
fish oil
placebo
Arm Description
Outcomes
Primary Outcome Measures
Percent change in flow-mediated vasodilation by brachial artery ultrasound at 2 months
Percent change in flow-mediated vasodilation by brachial artery ultrasound
Change in heart rate variability indices at 2 months
Change in heart rate variability indices on holter monitor
Percent change in carotid intimal media thickness at 12 months
Percent change in carotid intimal media thickness on ultrasound
Secondary Outcome Measures
Change in QT dispersion interval at 2 months
Change in QT dispersion interval on holter monitor
Full Information
NCT ID
NCT00454493
First Posted
March 29, 2007
Last Updated
March 11, 2019
Sponsor
Olive View-UCLA Education & Research Institute
Collaborators
Reliant Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00454493
Brief Title
The Effect of Fish Oil Supplementation on Endothelial Function, Heart Rate Variability and Intimal Media Thickness of Patients With Coronary Artery Disease
Official Title
The Effect of Fish Oil Supplementation on Endothelial Function, Heart Rate Variability and Intimal Media Thickness of Patients With Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Olive View-UCLA Education & Research Institute
Collaborators
Reliant Pharmaceuticals
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
omacor, fish oil, omega 3, fatty acids, coronary artery disease, endothelial function, heart rate variability, carotid intimal media thickness, QT dispersion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, placebo-controlled, randomized, double-blind trial
Masking
Double
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fish oil
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Omacor (omega-3-acid ethyl esters)
Primary Outcome Measure Information:
Title
Percent change in flow-mediated vasodilation by brachial artery ultrasound at 2 months
Description
Percent change in flow-mediated vasodilation by brachial artery ultrasound
Time Frame
2 months
Title
Change in heart rate variability indices at 2 months
Description
Change in heart rate variability indices on holter monitor
Time Frame
2 months
Title
Percent change in carotid intimal media thickness at 12 months
Description
Percent change in carotid intimal media thickness on ultrasound
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Change in QT dispersion interval at 2 months
Description
Change in QT dispersion interval on holter monitor
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Ejection fraction <40%
Underlying atrial or ventricular arrhythmia
History of rheumatoid arthritis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheba K Meymandi, M.D., FACC
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
OV-UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of Fish Oil Supplementation on Endothelial Function, Heart Rate Variability and Intimal Media Thickness of Patients With Coronary Artery Disease
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