Women With Chest Pain and Normal Coronary Arteries Study

• Status: Terminated
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anna Huskin
• Collaborator: Astellas Pharma US, Inc.
• Treatments: Aspirin; Lisinopril; Simvastatin

Criteria

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)