Renal Artery Stenosis in Coronary Artery Disease: Medical Therapy Versus Medical Therapy Plus Renal Artery Stenting in Preventing Cardiac and Renal Outcomes. The Rationale and Study Design of a Prospective,Randomized Trial: the RASCAD Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Left Ventricular Mass (LVMI, g/m2) changes
研究概览
简要总结
The Stenting of Renal Artery Stenosis in Coronary Artery Disease (RASCAD) study is a randomized controlled trial designed to evaluate the effect of renal artery stenting+medical therapy versus medical therapy alone on left ventricular mass progression and cardiovascular morbidity and mortality in patients affected by coronary artery disease and renal artery stenosis.
详细描述
Patients with renal artery stenosis (RAS) have high frequency of alterations of left ventricular mass and function. Whether renal revascularization can improve cardiac function and structure in patients with RAS is not known.
The Stenting of Renal Artery Stenosis in Coronary Artery Disease (RASCAD) study was planned to test whether renal artery revascularization, compared with medical therapy, affects left ventricular hypertrophy progression and clinical outcomes in a high-risk population such as patients with evidence of coronary artery disease and RAS.
Incidental patients affected by ischemic heart disease,undergoing cardiac catheterization at a single institution, are also evaluated for the presence of RAS by renal angiography at the end of coronarography. Patients with RAS >50% and ≤80% are randomly assigned to stenting angioplasty plus medical therapy (angioplasty group) or to medical therapy alone (drug therapy group)and followed up. Patients, randomly assigned to the angioplasty group, are revascularized by stenting. All randomized patients receive antihypertensive, statin or antiplatelet drugs according to clinical indications. The planned duration of follow-up is 5 years.
The health profile of patients is described in full at study entry. Cardiovascular events (AMI, re-PTCA, cardiac heart failure, stroke,peripheral vascular disease),death, hospitalizations and medications are carefully registered throughout the study.
Standard echocardiography and renal ultrasound studies are performed at baseline and repeated every year. Echocardiography is performed following American Society of Echocardiography guidelines. LV mass is estimated using the Devereux formula and indexed to body surface area.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ischemic heart disease
- •angiographic diagnosis of atherosclerotic RAS >50% and ≤80%
排除标准
- •Atherosclerotic RAS>80%
- •RAS secondary to fibromuscular dysplasia
- •single functioning kidney and/or sCr >4 mg/dl
- •severe aortic valve stenosis
- •aortic aneurism necessitating surgery
研究组 & 干预措施
Drug therapy
Patients will be treated by standard medical therapy.
干预措施: Medical therapy (Drug)
Drug therapy + stenting angioplasty
Patients will be treated by standard medical therapy + stenting angioplasty of renal artery.
干预措施: stenting angioplasty plus medical therapy (Procedure)
结局指标
主要结局
Left Ventricular Mass (LVMI, g/m2) changes
时间窗: 1 year
Intervention in patients with RAS was hypothesized to produce a reduction in LVMI in a range between 5 to 10 g/m2. By using a 2-sided 2-sample t-test, it was calculated that a sample size of 168 patients (84 in the revascularization arm and 84 in the medical management arm) provides a 80% power to detect as significant (p\<0.01) a difference of -4.0 g/m2 between patients in the revascularization arm (expected change in LVMI: -9.2 ± 7.9 g/m2) and those in the medical management arm (expected change in LVMI: -5.2 ± 5.9 g/m2).
次要结局
- Cardiovascular mortality and morbidity(5 years)
- Progression of renal function(5 years)