A Phase 3 interventional study of stenting angioplasty plus medical therapy and Medical therapy in Renal Artery Stenosis and Left Ventricular Hypertrophy, sponsored by Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2010-08-02.
Sponsored by Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele · Phase 3, Interventional, and Treatment
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.
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.
57 studies on the registry are indexed under Renal Artery Obstruction; 8 are open to participants now.
This study's planned enrollment of 168 is above the median of 100 across 41 interventional studies indexed under Renal Artery Obstruction.
Browse Renal Artery Obstruction studies →Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be treated by standard medical therapy.
Drug: Medical therapy
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 will be treated by standard medical therapy. Medical therapy is based on antihypertensive, statin or antiplatelet drugs according with clinical indications.
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).
Time frame: 1 year
Cardiovascular mortality and morbidity
Time frame: 5 years
Progression of renal function
Time frame: 5 years
This study is status unknown, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele