Women With Chest Pain and Normal Coronary Arteries Study

Northwestern University3 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Chest Pain

Interventions

AspirinDRUG

Aspirin 81 mg daily

LisinoprilDRUG

Lisinopril 10 mg every night

SimvastatinDRUG

Simvastatin 20 mg every night

LovazaDRUG

Lovaza 1 gram daily

Therapeutic Lifestyle ChangesBEHAVIORAL

Therapeutic lifestyle changes will be initiated with the assistance of a dietician, including diet counseling, exercise recommendation, and weight maintenance/weight loss.

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Female gender 2. Age 30 or greater 3. Present with symptoms suggestive of Angina (Typical or "Atypical") 4. Abnormal myocardial perfusion scan 5. Referred for angiography 6. Normal (0% stenosis) versus Nonobstructive coronary artery disease (CAD) (\<50% stenosis) 7. Evidence of endothelial dysfunction. Exclusion Criteria: 1. Coronary vasospasm known or documented in cardiac catheterization 2. Obstructive CAD (greater than 50% stenosis) known or documented in cardiac catheterization 3. Pregnancy 4. Established CAD, history of revascularization with percutaneous transluminal coronary angioplasty (PTCA)/stent or coronary artery bypass graft (CABG) 5. Contraindications to magnetic resonance imaging (MRI) 6. Cardiac catheterization for valvular disease 7. Cardiac catheterization for heart failure assessment/biopsy 8. Known congestive heart failure (CHF)/hypertrophic obstructive cardiomyopathy (HOCM)/dilated cardiomyopathy (DCM) 9. Acute Renal Failure 10. Chronic renal failure (estimated glomerular filtration rare (eGFR) \<30 ml/min/1.73m\^2) or on hemodialysis 11. Known single kidney 12. History of peptic ulcer disease, known gastrointestinal bleed, known contraindication to aspirin 13. Known contraindication to statin 14. Known contraindication to adenosine (asthma, high degree atrial ventricular (AV) block)

Outcomes

Primary Outcomes

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).

The purpose of this study is to compare the effectiveness of standard medical therapy versus usual care in women with chest pain (CP), coronary endothelial dysfunction (CED) and unblocked coronary arteries. CED is a condition in which the layers of cells around the heart do not function properly and is believed to be a key factor in the development of atherosclerosis (fat deposits in arteries). In addition, CED is associated with an increased risk for suture cardiovascular events, such as heart attack and stroke.

Time frame: 1 year