Clinical trial NCT00454493: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Olive View-UCLA Education & Research Institute
Sponsor class: OTHER
Collaborators: name: Reliant Pharmaceuticals
First posted: 2007-03-30
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, placebo-controlled, randomized, double-blind trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent change in flow-mediated vasodilation by brachial artery ultrasound at 2 months
timeFrame: 2 months
measure: Change in heart rate variability indices at 2 months
timeFrame: 2 months
measure: Percent change in carotid intimal media thickness at 12 months
timeFrame: 2 months
Secondary outcomes:
measure: Change in QT dispersion interval at 2 months
timeFrame: 2 months
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: OV-UCLA Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Sheba K Meymandi, M.D., FACC
role: PRINCIPAL_INVESTIGATOR
References: