Stenting of Renal Artery Stenosis in Coronary Artery Disease Study

Phase 3

• Conditions: Renal Artery Stenosis; Left Ventricular Hypertrophy
• Interventions: Drug: Medical therapy; Procedure: stenting angioplasty plus medical therapy

• Registration Number: NCT01173666
• Lead Sponsor: Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-04
• Status Verified: 2010-07
• Study First Submitted: 2010-07-30
• Study First Submitted QC: 2010-07-30
• Last Update Submitted: 2010-07-30
• Study First Posted: 2010-08-02
• Last Update Posted: 2010-08-02
• Primary Completion: 2011-04
• Study Completion: 2011-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug therapy	Medical therapy	Patients will be treated by standard medical therapy.
Drug therapy + stenting angioplasty	stenting angioplasty plus medical therapy	Patients will be treated by standard medical therapy + stenting angioplasty of renal artery.

Primary Outcome Measures

Name	Time	Method
Left Ventricular Mass (LVMI, g/m2) changes	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).

Secondary Outcome Measures

Name	Time	Method
Cardiovascular mortality and morbidity	5 years
Progression of renal function	5 years

Trial Locations

Locations (1)

Cardiology Division, University of Catania, Azienda Policlinico-Vittorio Emanuele; 🇮🇹 Catania, Italy