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

NCT00454493 | Completed

• 1 other identifier: 05H-561610
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

• Change in heart rate variability indices at 2 months

  Change in heart rate variability indices on holter monitor

  2 months

• Percent change in carotid intimal media thickness at 12 months

  Percent change in carotid intimal media thickness on ultrasound

  2 months

Secondary Outcomes (1)

• Change in QT dispersion interval at 2 months

  2 months

Study Arms (2)

fish oil

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

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

Interventions

Omacor (omega-3-acid ethyl esters) DRUG

fish oil; placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Olive View-UCLA Education & Research Institute: lead
• Reliant Pharmaceuticals: collaborator

Study Sites (1)

OV-UCLA Medical Center

Sylmar, California, 91342, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Omacor

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Sheba K Meymandi, M.D., FACC

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiovascular Research

Model Details: prospective, placebo-controlled, randomized, double-blind trial

Study Record Dates

• First Submitted: March 29, 2007
• First Posted: March 30, 2007
• Study Start: August 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 13, 2019

Record last verified: 2007-03

Locations

US (1)