Women With Chest Pain and Normal Coronary Arteries Study: A Randomized Study of Medical Treatment and Therapeutic Lifestyle Changes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female gender
- •Age 30 or greater
- •Present with symptoms suggestive of Angina (Typical or "Atypical")
- •Abnormal myocardial perfusion scan
- •Referred for angiography
- •Normal (0% stenosis) versus Nonobstructive coronary artery disease (CAD) (<50% stenosis)
- •Evidence of endothelial dysfunction.
排除标准
- •Coronary vasospasm known or documented in cardiac catheterization
- •Obstructive CAD (greater than 50% stenosis) known or documented in cardiac catheterization
- •Established CAD, history of revascularization with percutaneous transluminal coronary angioplasty (PTCA)/stent or coronary artery bypass graft (CABG)
- •Contraindications to magnetic resonance imaging (MRI)
- •Cardiac catheterization for valvular disease
- •Cardiac catheterization for heart failure assessment/biopsy
- •Known congestive heart failure (CHF)/hypertrophic obstructive cardiomyopathy (HOCM)/dilated cardiomyopathy (DCM)
- •Acute Renal Failure
- •Chronic renal failure (estimated glomerular filtration rare (eGFR) <30 ml/min/1.73m^2) or on hemodialysis
- •Known single kidney
- •History of peptic ulcer disease, known gastrointestinal bleed, known contraindication to aspirin
- •Known contraindication to statin
- •Known contraindication to adenosine (asthma, high degree atrial ventricular (AV) block)
研究组 & 干预措施
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.
干预措施: Aspirin (Drug)
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.
干预措施: Lisinopril (Drug)
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.
干预措施: Simvastatin (Drug)
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.
干预措施: Lovaza (Drug)
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.
干预措施: Therapeutic Lifestyle Changes (Behavioral)
结局指标
主要结局
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).
时间窗: 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.
次要结局
未报告次要终点