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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Omacor (omega-3-acid ethyl esters)

• Registration Number: NCT00454493
• Lead Sponsor: Olive View-UCLA Education & Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Status Verified: 2007-03
• Study First Submitted: 2007-03-29
• Study First Submitted QC: 2007-03-29
• Study First Posted: 2007-03-30
• Primary Completion: 2008-10
• Study Completion: 2008-12
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fish oil	Omacor (omega-3-acid ethyl esters)	-
placebo	Omacor (omega-3-acid ethyl esters)	-

Primary Outcome Measures

Name	Time	Method
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
Percent change in carotid intimal media thickness at 12 months	2 months	Percent change in carotid intimal media thickness on ultrasound
Change in heart rate variability indices at 2 months	2 months	Change in heart rate variability indices on holter monitor

Secondary Outcome Measures

Name	Time	Method
Change in QT dispersion interval at 2 months	2 months	Change in QT dispersion interval on holter monitor

Trial Locations

Locations (1)

OV-UCLA Medical Center; 🇺🇸 Sylmar, California, United States