Ignite Creation Date:
2024-05-06 @ 3:46 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02366091
Status:
COMPLETED
Last Update Posted:
2021-10-21
First Post:
2015-02-05
Brief Title:
Inflammation and Coronary Endothelial Function
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Inflammation and Coronary Endothelial Function in Patients With Coronary Artery Disease
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 anti-inflammatory agents can improve abnormal coronary artery function in patients with coronary artery disease CAD and abnormal coronary artery endothelial function
Detailed Description:
Sometimes in patients with coronary artery disease CAD even though blood pressure is controlled the patients are on cholesterol medication not smoking eating properly and have normal levels of physical activity the investigators still see development of new blockages progression of existing blockages and sometimes even clinical events like heart attacks and strokes Therefore the investigators are always trying to find additional ways to decrease the progression of existing blockages and to prevent new ones
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 It 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 and 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
Methotrexate and colchicine are anti-inflammatory agents approved by the Food and Drug Administration FDA to treat arthritis and some other conditions These drugs are 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 methotrexate colchicine andor their combination in this research study
This study will involve 24 weeks of anti-inflammatory drugs 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 It 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 and 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
Methotrexate and colchicine are anti-inflammatory agents approved by the Food and Drug Administration FDA to treat arthritis and some other conditions These drugs are 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 methotrexate colchicine andor their combination in this research study
This study will involve 24 weeks of anti-inflammatory drugs 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 |
|---|---|---|---|
| R01HL120905 | NIH | None | httpsreporternihgovquickSearchR01HL120905 |