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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Reliant Pharmaceuticals
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00454493
First received: March 29, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Coronary Artery Disease
 Drug: Omacor (omega-3-acid ethyl esters)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of Fish Oil Supplementation on Endothelial Function, Heart Rate Variability and Intimal Media Thickness of Patients With Coronary Artery Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Percent change in flow-mediated vasodilation by brachial artery ultrasound at 2 months
  • Change in heart rate variability indices at 2 months
  • Percent change in carotid intimal media thickness at 12 months

Secondary Outcome Measures:
  • Change in QT dispersion interval at 2 months

Estimated Enrollment: 100
Study Start Date: August 2006
Estimated Study Completion Date: July 2008
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454493

Contacts
Contact: Sheba K Meymandi, M.D.,FACC 818-364-4287 smeymandi@ladhs.org
Contact: Mahmoud I Traina, M.D. 818-364-4287 mitraina@gmail.com

Locations
United States, California
OV-UCLA Medical Center Recruiting
Sylmar, California, United States, 91342
Sponsors and Collaborators
University of California, Los Angeles
Reliant Pharmaceuticals
Investigators
Principal Investigator: Sheba K Meymandi, M.D., FACC University of California, Los Angeles
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00454493     History of Changes
Other Study ID Numbers: 05H-561610
Study First Received: March 29, 2007
Last Updated: March 29, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
omacor
fish oil
omega 3
fatty acids
coronary artery disease
 endothelial function
heart rate variability
carotid intimal media thickness
QT dispersion

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013