Stenting of Renal Artery Stenosis in Coronary Artery Disease Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Renal Artery Stenosis, Left Ventricular Hypertrophy

Intervention / Treatment
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* Procedure: stenting angioplasty plus medical therapy
* Drug: Medical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ischemic heart disease angiographic diagnosis of atherosclerotic RAS >50% and ≤80% Exclusion Criteria: Atherosclerotic RAS>80% RAS secondary to fibromuscular dysplasia AMI single functioning kidney and/or sCr >4 mg/dl severe aortic valve stenosis aortic aneurism necessitating surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Drug therapy<br>Patients will be treated by standard medical therapy. | Drug: Medical therapy<br>* Patients will be treated by standard medical therapy. Medical therapy is based on antihypertensive, statin or antiplatelet drugs according with clinical indications.<br>|
| Experimental: Drug therapy + stenting angioplasty<br>Patients will be treated by standard medical therapy + stenting angioplasty of renal artery. | Procedure: stenting angioplasty plus medical therapy<br>* Patients will be treated by stenting angioplasty of renal artery plus medical therapy. Medical therapy is based on antihypertensive, statin or antiplatelet drugs according to clinical indications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular Mass (LVMI, g/m2) changes | 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). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality and morbidity |  | 5 years | 
| Progression of renal function |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RAS, LVMI, Renal revascularization