Women With Chest Pain and Normal Coronary Arteries Study
NCT ID: NCT00743197
Last Updated: 2023-12-12
Study Results
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View full resultsBasic Information
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TERMINATED
NA
3 participants
INTERVENTIONAL
2008-05-31
2010-05-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Usual Care Group
USUAL CARE GROUP-therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.
No interventions assigned to this group
Medical Treatment Group
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.
Aspirin
Aspirin 81 mg daily
Lisinopril
Lisinopril 10 mg every night
Simvastatin
Simvastatin 20 mg every night
Lovaza
Lovaza 1 gram daily
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.
Interventions
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Aspirin
Aspirin 81 mg daily
Lisinopril
Lisinopril 10 mg every night
Simvastatin
Simvastatin 20 mg every night
Lovaza
Lovaza 1 gram daily
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
30 Years
90 Years
FEMALE
No
Sponsors
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Astellas Pharma US, Inc.
INDUSTRY
Northwestern University
OTHER
Responsible Party
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Principal Investigators
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Martha Gulati, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University
Chicago, Illinois, United States
Countries
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Other Identifiers
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AB-08-002
Identifier Type: -
Identifier Source: org_study_id