Clinical trial NCT00743197: Women With Chest Pain and Normal Coronary Arteries Study
Official title: Women With Chest Pain and Normal Coronary Arteries Study: A Randomized Study of Medical Treatment and Therapeutic Lifestyle Changes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chest Pain
Keywords: coronary artery disease (CAD)
chest pain
myocardial ischemia
endothelial function
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2008-08-28
Enrollment: 3
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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.

Eligibility 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)

Primary outcomes:
measure: 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).
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Martha Gulati, MD
role: PRINCIPAL_INVESTIGATOR
References: