The Effect of Fish Oil Supplementation on Endothelial Function, Heart Rate Variability and Intimal Media Thickness of Patients With Coronary Artery Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00454493|
Recruitment Status : Unknown
Verified March 2007 by University of California, Los Angeles.
Recruitment status was: Recruiting
First Posted : March 30, 2007
Last Update Posted : March 30, 2007
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 or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Omacor (omega-3-acid ethyl esters)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effect of Fish Oil Supplementation on Endothelial Function, Heart Rate Variability and Intimal Media Thickness of Patients With Coronary Artery Disease|
|Study Start Date :||August 2006|
|Estimated Study Completion Date :||July 2008|
- 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
- Change in QT dispersion interval at 2 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454493
|Contact: Sheba K Meymandi, M.D.,FACCemail@example.com|
|Contact: Mahmoud I Traina, M.D.||firstname.lastname@example.org|
|United States, California|
|OV-UCLA Medical Center||Recruiting|
|Sylmar, California, United States, 91342|
|Principal Investigator:||Sheba K Meymandi, M.D., FACC||University of California, Los Angeles|