Diagnosis and Treatment of Coronary Artery Disease in Severe Peripheral Artery Disease After Lower Extremity Revascularization
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 450
- 试验地点
- 14
- 主要终点
- Major adverse cardiovascular events (MACE)
研究概览
简要总结
Peripheral artery disease, lack or blood flow to the legs, has a high prevalence in the Veteran population. In patients with severe peripheral artery disease that requires an endovascular or surgical intervention for lower leg revascularization, the long-term mortality of approximately 50% is worse that most cancers. The goal of this study is to develop a management strategy to improve cardiovascular outcomes in this high-risk peripheral artery disease population after lower extremity revascularization.
详细描述
This study will be to conduct a randomized, controlled, multi-center clinical trial to evaluate a non-invasive management strategy of a computed topography (CT) scan of the coronary arteries and computational analysis of coronary perfusion with selective coronary revascularization plus optimal medical therapy compared to optimal medical therapy. Therefore, this study will provide the opportunity for Veterans to participate in a clinical trial to reduce the very high cardiac-related mortality rate in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 50 to 85
- •Severe intermittent claudication with ABI < 0.6 or monophasic waveform if non-compressible and TBI < 0.6
- •Chronic limb threatening ischemia (CLTI) with pain at rest (Rutherford Category 4) with ABI < 0.5 or TBI < 0.6
- •CLTI with minor tissue loss (Rutherford Category 5) with ABI < 0.5 or TBI < 0.6
- •Completed Lower Extremity Revascularization and enrolled within 45 days
- •The patient or legal representative will provide informed written consent
- •The patient has a life expectancy of at least 1 year
排除标准
- •Major tissue loss of the ischemic limb (Rutherford Category 6)
- •Uncompensated congestive heart failure (NYHA class IV)
- •Myocardial infarction or stroke within the past 90 days
- •Prior coronary artery bypass graft (CABG) revascularization surgery
- •Prior percutaneous coronary intervention (PCI) with angioplasty or stenting
- •Presence of a pacemaker
- •Congestive heart failure with Ejection Fraction < 30%
- •Elevated liver function tests more than twice the upper limit of normal
- •Severe Chronic renal disease (Glomerular Filtration Rate, GFR < 30) or on hemodialysis
- •Pregnancy, Human Immunodeficiency Virus, or organ transplant recipients
- •Current malignancy or malignancy within the last two years unless the treating oncologic physician provides prognosis of an anticipated 2- year survival (i.e., adequately treated non-melanoma skin cancer or adequately treated prostate cancer without metastatic disease)
- •Any condition the review panel determines would make the patient unsuitable for participation in the study
结局指标
主要结局
Major adverse cardiovascular events (MACE)
时间窗: 2 years
cardiovascular-related death or myocardial infarction
次要结局
- Amputation-free survival(2 years)
- Myocardioal infarction(2 years)
- All-cause mortality(2 years)
- Cardiovascular-related death(2 years)