Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454493
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2007-03-29
Brief Title:
The Effect of Fish Oil Supplementation on Endothelial Function Heart Rate Variability and Intimal Media Thickness of Patients With Coronary Artery Disease
Sponsor:
Olive View-UCLA Education Research Institute
Organization:
Olive View-UCLA Education Research Institute
Study Overview
Official Title:
The Effect of Fish Oil Supplementation on Endothelial Function Heart Rate Variability and Intimal Media Thickness of Patients With Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None