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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
Olive View-UCLA Education & Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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
  2. Age >18 and <75.

Exclusion Criteria:

  1. Baseline fish oil intake ≥1g/day or fish intake >100g/day
  2. Need for urgent or emergent CABG
  3. Contraindication for plavix, aspirin or statin
  4. Gastrointestinal malabsorption syndrome
  5. Pregnancy
  6. Oral contraceptive use
  7. Ejection fraction <40%
  8. Underlying atrial or ventricular arrhythmia
  9. 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

First Posted
March 29, 2007
Last Updated
March 11, 2019
Sponsor
Olive View-UCLA Education & Research Institute
Collaborators
Reliant Pharmaceuticals
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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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