Ignite Creation Date:
2024-05-05 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00743197
Status:
TERMINATED
Last Update Posted:
2023-12-12
First Post:
2008-08-26
Brief Title:
Women With Chest Pain and Normal Coronary Arteries Study
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Women With Chest Pain and Normal Coronary Arteries Study A Randomized Study of Medical Treatment and Therapeutic Lifestyle Changes
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to departure of PI from institution
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 compare the effectiveness of standard medical therapy versus usual care in women with chest pain coronary endothelial dysfunction and unblocked coronary arteries
Coronary endothelial dysfunction CED is a condition in which the layers of cells around the heart do not function properly and is believed to be key factor in the development of atherosclerosis fat deposits in arteries In addition CED is associated with an increased risk for future cardiovascular events such as heart attack and stroke
A coronary angiogram allows physicians to see if any of the arteries in the heart are blocked usually by fatty plaque In many instances angiograms in women experiencing chest pain do not show evidence of coronary disease free of significant plaque build-up Currently there is no standard of care treatment plan for patients with normal coronary arteries despite symptoms of chest pain and as a result these patients may not receive medical treatment However these women often return to their physicians more than once with chest pain and go through a similar battery of tests
Coronary endothelial dysfunction CED is a condition in which the layers of cells around the heart do not function properly and is believed to be key factor in the development of atherosclerosis fat deposits in arteries In addition CED is associated with an increased risk for future cardiovascular events such as heart attack and stroke
A coronary angiogram allows physicians to see if any of the arteries in the heart are blocked usually by fatty plaque In many instances angiograms in women experiencing chest pain do not show evidence of coronary disease free of significant plaque build-up Currently there is no standard of care treatment plan for patients with normal coronary arteries despite symptoms of chest pain and as a result these patients may not receive medical treatment However these women often return to their physicians more than once with chest pain and go through a similar battery of tests
Detailed Description:
Endothelial function testing will be performed on women without significant coronary disease in order to help identify women who may be likely to develop coronary artery disease CAD and who would benefit from aggressive lifestyle dietary counseling exercise or medical treatment with aspirin and cholesterol and blood pressure lowering medications interventions
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