Stenting of Renal Artery Stenosis in Coronary Artery Disease Study (RASCAD)

Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

Status and phase: Unknown; Phase 3

Conditions: Renal Artery Stenosis; Left Ventricular Hypertrophy

Treatments: Drug: Medical therapy; Procedure: stenting angioplasty plus medical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01173666

RC-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 168 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 2 patient groups, including a placebo group

Drug therapy

Placebo Comparator group

Description:

Patients will be treated by standard medical therapy.

Treatment:

Drug: Medical therapy

Drug therapy + stenting angioplasty

Experimental group

Description:

Patients will be treated by standard medical therapy + stenting angioplasty of renal artery.

Treatment:

Procedure: stenting angioplasty plus medical therapy