Women With Chest Pain and Normal Coronary Arteries Study

Not Applicable

Terminated

• Conditions: Chest Pain
• Interventions: Drug: Aspirin; Drug: Lisinopril; Drug: Simvastatin; Drug: Lovaza; Behavioral: Therapeutic Lifestyle Changes

• Registration Number: NCT00743197
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-08-26
• Study First Submitted QC: 2008-08-26
• Study First Posted: 2008-08-28
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2011-09-13
• Results First Submitted QC: 2011-10-19
• Results First Posted: 2011-11-23
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical Treatment Group	Therapeutic Lifestyle Changes	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.
Medical Treatment Group	Lisinopril	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.
Medical Treatment Group	Aspirin	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.
Medical Treatment Group	Simvastatin	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.
Medical Treatment Group	Lovaza	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.

Primary Outcome Measures

Name	Time	Method
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).	1 year	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.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States