Women With Chest Pain and Normal Coronary Arteries Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chest Pain

Intervention / Treatment
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* Drug: Aspirin
* Drug: Lisinopril
* Drug: Simvastatin
* Drug: Lovaza
* Behavioral: Therapeutic Lifestyle Changes


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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care Group<br>USUAL CARE GROUP-therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician. | |
| Active Comparator: Medical Treatment Group<br>TREATMENT GROUP-therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes. | Drug: Aspirin<br>* Aspirin 81 mg daily<br>Drug: Lisinopril<br>* Lisinopril 10 mg every night<br>Drug: Simvastatin<br>* Simvastatin 20 mg every night<br>* Other names: Zocor;Drug: Lovaza<br>* Lovaza 1 gram daily<br>* Other names: Fish Oil, Omega-3;Behavioral: Therapeutic Lifestyle Changes<br>* Therapeutic lifestyle changes will be initiated with the assistance of a dietician, including diet counseling, exercise recommendation, and weight maintenance/weight loss.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease (CAD), chest pain, myocardial ischemia, endothelial function