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

March 11, 2019 updated by: Sheba Meymandi, Olive View-UCLA Education & Research Institute

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sylmar, California, United States, 91342
        • OV-UCLA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: Omacor (omega-3-acid ethyl esters)
Active Comparator: fish oil
Drug: Omacor (omega-3-acid ethyl esters)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 months
Change in heart rate variability indices at 2 months
Time Frame: 2 months
Change in heart rate variability indices on holter monitor
2 months
Percent change in carotid intimal media thickness at 12 months
Time Frame: 2 months
Percent change in carotid intimal media thickness on ultrasound
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in QT dispersion interval at 2 months
Time Frame: 2 months
Change in QT dispersion interval on holter monitor
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Olive View-UCLA Education & Research Institute

Collaborators

Reliant Pharmaceuticals

Investigators

  • Principal Investigator: Sheba K Meymandi, M.D., FACC, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

March 29, 2007

First Submitted That Met QC Criteria

March 29, 2007

First Posted (Estimate)

March 30, 2007

Study Record Updates

Last Update Posted (Actual)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05H-561610

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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