Clinical Trial: Women With Chest Pain and Normal Coronary Arteries Study
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Women With Chest Pain and Normal Coronary Arteries Study: A Randomized Study of Medical Treatment and Therapeutic Lifestyle Changes
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.
Detailed Summary: 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.
Sponsor: Anna Huskin
Current Primary Outcome: Effectiveness of Therapy Compared to Usual Care, in Those Women With Chest Pain (CP), Reversible Ischemia by Stress Testing and Nonobstructive Coronary Artery Disease (CAD) by Angiography Who Are Found to Have Coronary Endothelial Dysfunction (CED). [ Time Frame: 1 year ]
Original Primary Outcome: Assess effectiveness of therapy compared to usual care, in those women with CP, reversible ischemia by stress testing and nonobstructive CAD by angiography who are found to have coronary endothelial dysfunction. [ Time Frame: 1 year ]
Current Secondary Outcome: The Role and Function of Endothelial Progenitor Cells (EPCs) in the Presence of Proven Endothelial Dysfunction and the Response of EPCs to Medical Therapy for Endothelial Dysfunction. [ Time Frame: 1 year ]
Original Secondary Outcome: To assess the role and function of endothelial progenitor cells (EPCs) in the presence of proven endothelial dysfunction and the response of EPCs to medical therapy for endothelial dysfunction. [ Time Frame: 1 year ]
Information By: Northwestern University
Dates:
Date Received: August 26, 2008
Date Started: May 2008
Date Completion:
Last Updated: November 30, 2011
Last Verified: November 2011