Women With Chest Pain and Normal Coronary Arteries Study

Northwestern University

Status: Terminated

Conditions: Chest Pain

Treatments: Drug: Lisinopril; Behavioral: Therapeutic Lifestyle Changes; Drug: Aspirin; Drug: Simvastatin; Drug: Lovaza

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00743197

AB-08-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: Female

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Usual Care Group

No Intervention group

Description:

USUAL CARE GROUP-therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.

Medical Treatment Group

Active Comparator group

Description:

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.

Treatment:

Drug: Aspirin

Drug: Lovaza

Drug: Simvastatin

Behavioral: Therapeutic Lifestyle Changes

Drug: Lisinopril