Stenting of Renal Artery Stenosis in Coronary Artery Disease Study (RASCAD)
Recruitment status was: Recruiting
|Renal Artery Stenosis Left Ventricular Hypertrophy||Procedure: stenting angioplasty plus medical therapy Drug: Medical therapy||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
- Left Ventricular Mass (LVMI, g/m2) changes [ Time Frame: 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).
- Cardiovascular mortality and morbidity [ Time Frame: 5 years ]
- Progression of renal function [ Time Frame: 5 years ]
|Study Start Date:||April 2006|
|Estimated Study Completion Date:||April 2011|
|Estimated Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Placebo Comparator: Drug therapy
Patients will be treated by standard medical therapy.
Drug: Medical therapy
Patients will be treated by standard medical therapy. Medical therapy is based on antihypertensive, statin or antiplatelet drugs according with clinical indications.
Experimental: Drug therapy + stenting angioplasty
Patients will be treated by standard medical therapy + stenting angioplasty of renal artery.
Procedure: stenting angioplasty plus medical therapy
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173666
|Contact: Carmelita Marcantoni, M.D.||0039 095 firstname.lastname@example.org|
|Contact: Giovanni Tripepi, PhD||0039 0965 email@example.com|
|Cardiology Division, University of Catania, Azienda Policlinico-Vittorio Emanuele||Recruiting|
|Catania, Italy, 95100|
|Contact: Carmelita Marcantoni, M.D. 0039 095 726 3378 firstname.lastname@example.org|
|Contact: Corrado Tamburino, M.D. 0039 095 743 6201 email@example.com|
|Principal Investigator: Corrado Tamburino, M.D.|
|Principal Investigator:||Carmelita Marcantoni, M.D.||Nephrology Division, Cannizzaro Hospital, Catania, Italy|