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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00454493
• Other study ID #: 05H-561610
• Status: Completed
• Phase: N/A
• Start date: August 2006
• Est. completion date: December 2008

Study information

• Verified date: March 2007
• Source: Olive View-UCLA Education & Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
United States	OV-UCLA Medical Center	Sylmar	California

Sponsors (2)

Lead Sponsor	Collaborator
Olive View-UCLA Education & Research Institute	Reliant Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in flow-mediated vasodilation by brachial artery ultrasound at 2 months	Percent change in flow-mediated vasodilation by brachial artery ultrasound	2 months
Primary	Change in heart rate variability indices at 2 months	Change in heart rate variability indices on holter monitor	2 months
Primary	Percent change in carotid intimal media thickness at 12 months	Percent change in carotid intimal media thickness on ultrasound	2 months
Secondary	Change in QT dispersion interval at 2 months	Change in QT dispersion interval on holter monitor	2 months