Women With Chest Pain and Normal Coronary Arteries Study

Chest Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00743197
• Other study ID #: AB-08-002
• Status: Terminated
• Phase: N/A
• Start date: May 2008
• Est. completion date: May 2010

Study information

• Verified date: November 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chest Pain

Intervention

Drug:
• Aspirin
Aspirin 81 mg daily
• Lisinopril
Lisinopril 10 mg every night
• Simvastatin
Simvastatin 20 mg every night
• Lovaza
Lovaza 1 gram daily

Behavioral:
• Therapeutic Lifestyle Changes
Therapeutic lifestyle changes will be initiated with the assistance of a dietician, including diet counseling, exercise recommendation, and weight maintenance/weight loss.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Astellas Pharma US, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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.	1 year