Ignite Creation Date:
2024-05-06 @ 7:54 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02624180
Status:
COMPLETED
Last Update Posted:
2021-10-21
First Post:
2015-11-11
Brief Title:
Inflammatory Pathogenesis of Coronary Atherosclerosis in HIV
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Inflammatory Pathogenesis of Coronary Atherosclerosis in HIV
Status:
COMPLETED
Status Verified Date:
2021-09
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 investigators are studying whether an anti-inflammatory intervention improves impaired coronary endothelial function CEF in HIV people with no clinical coronary artery disease CAD
Detailed Description:
Survival in people with HIV has significantly improved with the use of antiretroviral therapy ART but HIV people now experience an increasing burden of chronic diseases including coronary atherosclerosis and coronary artery disease CAD HIV patients manifest an increased risk of CAD and its consequences possibly due to interplay of inflammation with traditional risk factors smoking high cholesterol and poor diet some of the latter accentuated by ART
What the investigators are studying in this program is the function of the coronary arteries and in particular the inner lining of the arteries called the endothelium in patients with HIV The endothelium has several important functions one of them is that under conditions of stress it releases a substance called nitric oxide which increases the size of the artery and increases blood flow When it is not functioning normally the artery does not increase as much and blood flow does not increase during stress
The investigators study coronary artery function with magnetic resonance imaging or MRI MRI is a method of obtaining images of what is happening inside the body MRI does not involve radiation x-ray or injection of contrast The investigators can measure flow in the artery and the dimension of the artery at rest and with a handgrip stress and learn the extent to which the artery dilates and flow increases with the stress The investigators believe that inflammation can interfere with normal function and that by decreasing inflammation abnormal endothelial function may be improved
Colchicine is an anti-inflammatory agent approved by the Food and Drug Administration FDA to treat arthritis and some other conditions This drug is not approved for use to suppress inflammation in patients with coronary artery disease and improve coronary artery endothelial function The FDA is allowing the use of colchicine or a placebo in this research study
This study will involve 24 weeks of colchicine or placebo and 3 Magnetic Resonance Imaging MRI scans of the heart and other study procedures
What the investigators are studying in this program is the function of the coronary arteries and in particular the inner lining of the arteries called the endothelium in patients with HIV The endothelium has several important functions one of them is that under conditions of stress it releases a substance called nitric oxide which increases the size of the artery and increases blood flow When it is not functioning normally the artery does not increase as much and blood flow does not increase during stress
The investigators study coronary artery function with magnetic resonance imaging or MRI MRI is a method of obtaining images of what is happening inside the body MRI does not involve radiation x-ray or injection of contrast The investigators can measure flow in the artery and the dimension of the artery at rest and with a handgrip stress and learn the extent to which the artery dilates and flow increases with the stress The investigators believe that inflammation can interfere with normal function and that by decreasing inflammation abnormal endothelial function may be improved
Colchicine is an anti-inflammatory agent approved by the Food and Drug Administration FDA to treat arthritis and some other conditions This drug is not approved for use to suppress inflammation in patients with coronary artery disease and improve coronary artery endothelial function The FDA is allowing the use of colchicine or a placebo in this research study
This study will involve 24 weeks of colchicine or placebo and 3 Magnetic Resonance Imaging MRI scans of the heart and other study procedures
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HL125059 | NIH | None | httpsreporternihgovquickSearch1R01HL125059 |