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OpenTrials
Completed

NCT Number: NCT00454493

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OV-UCLA Medical Center

Sylmar, California, 91342, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • 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

Treatment and study plan

Omacor (Omega-3-acid ethyl esters)

Drug

Primary outcomes

  1. Percent change in flow-mediated vasodilation by brachial artery ultrasound at 2 months

    Time frame: 2 months

    Percent change in flow-mediated vasodilation by brachial artery ultrasound

  2. Change in heart rate variability indices at 2 months

    Time frame: 2 months

    Change in heart rate variability indices on holter monitor

  3. Percent change in carotid intimal media thickness at 12 months

    Time frame: 2 months

    Percent change in carotid intimal media thickness on ultrasound

Secondary outcomes

  1. Change in QT dispersion interval at 2 months

    Time frame: 2 months

    Change in QT dispersion interval on holter monitor

Sponsors and collaborators

Lead sponsor

Olive View-UCLA Education & Research Institute

Other

Collaborators

  • Reliant Pharmaceuticals

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 30, 2007
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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