Women With Chest Pain and Normal Coronary Arteries Study

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.

Conditions

• Chest Pain

Interventions

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.

Sponsors & Collaborators

• Astellas Pharma US, Inc.

  collaborator INDUSTRY

• Northwestern University

  lead OTHER

Principal Investigators

• Martha Gulati, MD · Northwestern University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

90 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-05-31

Primary Completion

2010-05-31

Completion

2010-05-31

Countries

• United States

Study Locations