The Effect of Fish Oil Supplementation on Endothelial Function, Heart Rate Variability and Intimal Media Thickness of Patients With Coronary Artery Disease

Sponsor

Olive View-UCLA Education & Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00454493

Collaborator

Reliant Pharmaceuticals (Industry)

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Omacor (omega-3-acid ethyl esters)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective, placebo-controlled, randomized, double-blind trialprospective, placebo-controlled, randomized, double-blind trial

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2006

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: fish oil	Drug: Omacor (omega-3-acid ethyl esters)
Placebo Comparator: placebo	Drug: Omacor (omega-3-acid ethyl esters)

Arm

Intervention/Treatment

Active Comparator: fish oil

Drug: Omacor (omega-3-acid ethyl esters)

Placebo Comparator: placebo

Drug: Omacor (omega-3-acid ethyl esters)

Outcome Measures

Primary Outcome Measures

Percent change in flow-mediated vasodilation by brachial artery ultrasound at 2 months [2 months]
Percent change in flow-mediated vasodilation by brachial artery ultrasound
Change in heart rate variability indices at 2 months [2 months]
Change in heart rate variability indices on holter monitor
Percent change in carotid intimal media thickness at 12 months [2 months]
Percent change in carotid intimal media thickness on ultrasound

Secondary Outcome Measures

Change in QT dispersion interval at 2 months [2 months]
Change in QT dispersion interval on holter monitor

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.