Women With Chest Pain and Normal Coronary Arteries Study

Condition(s) targeted: Chest Pain

Intervention: aspirin, lisinopril, simvastatin, lovaza (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Northwestern University

Official(s) and/or principal investigator(s):
Martha Gulati, MD, Principal Investigator, Affiliation: Northwestern University

Overall contact:
Amy Miller, RN, Phone: 312-695-2734, Email: ammiller@nmh.org

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.

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

Study design: Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment

Primary outcome: Assess effectiveness of therapy compared to usual care, in those women with CP, reversible ischemia by stress testing and nonobstructive CAD by angiography who are found to have coronary endothelial dysfunction.

Secondary outcome: To assess the role and function of endothelial progenitor cells (EPCs) in the presence of proven endothelial dysfunction and the response of EPCs to medical therapy for endothelial dysfunction.

Detailed 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 CAD and who would benefit from aggressive lifestyle (dietary counseling, exercise) or medical (treatment with aspirin and cholesterol and blood pressure lowering medications) interventions.

Minimum age: 30 Years. Maximum age: 90 Years. Gender(s): Female.

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 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 PTCA/stent or CABG

5. Contraindications to MRI

6. Cardiac catheterization for valvular disease

7. Cardiac catheterization for heart failure assessment/biopsy

8. Known CHF/HOCM/DCM;

9. Acute Renal Failure

10. Chronic renal failure (eGFR <30 ml/min/1. 73m2) 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 AV block)

Amy Miller, RN, Phone: 312-695-2734, Email: ammiller@nmh.org

Northwestern University, Chicago, Illinois 60611, United States; Recruiting
Byron Yip, Phone: 312-695-3270, Email: b-yip@northwestern.edu
Neil Stone, MD, Sub-Investigator
Doug Losordo, MD, Sub-Investigator
Charles Davidson, MD, Sub-Investigator
Richard Lee, MD, Sub-Investigator
Robert Bonow, MD, Sub-Investigator

Starting date: May 2008
Ending date: May 2010
Last updated: June 5, 2009