Trial | NCT00454493  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    icosapent ethyl ...

  • Study Participants

    71
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.
Study Started
Aug 31
2006
Primary Completion
Oct 31
2008
Study Completion
Dec 31
2008
Last Update
Mar 13
2019

Drug Omacor (omega-3-acid ethyl esters)

fish oil Active Comparator

placebo Placebo Comparator

Criteria 

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
No Results Posted