NCT00743197

Women With Chest Pain and Normal Coronary Arteries Study

Women With Chest Pain and Normal Coronary Arteries Study: A Randomized Study of Medical Treatment and Therapeutic Lifestyle Changes

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: Female
• Age: 30 Years – 90 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Chest Pain

Interventions

Type	Name	Description
DRUG	Aspirin	Aspirin 81 mg daily
DRUG	Lisinopril	Lisinopril 10 mg every night
DRUG	Simvastatin	Simvastatin 20 mg every night
DRUG	Lovaza	Lovaza 1 gram daily
BEHAVIORAL	Therapeutic Lifestyle Changes	Therapeutic lifestyle changes will be initiated with the assistance of a dietician, including diet counseling, exercise recommendation, and weight maintenance/weight loss.

Timeline

• Start date: 2008-05-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2008-08-28
• Last updated: 2023-12-12
• Results posted: 2011-11-23

Locations

1 site across 1 country: United States