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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Information provided by:
Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
ClinicalTrials.gov Identifier:
NCT01173666
First received: July 30, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Renal Artery Stenosis
Left Ventricular Hypertrophy
Procedure: stenting angioplasty plus medical therapy
Drug: Medical therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele:

Primary Outcome Measures:
  • Left Ventricular Mass (LVMI, g/m2) changes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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:
  • Cardiovascular mortality and morbidity [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Progression of renal function [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 168
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)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173666

Contacts
Contact: Carmelita Marcantoni, M.D. 0039 095 7263378 carmelita.marcantoni@gmail.com
Contact: Giovanni Tripepi, PhD 0039 0965 393262 gtripepi@ibim.cnr.it

Locations
Italy
Cardiology Division, University of Catania, Azienda Policlinico-Vittorio Emanuele Recruiting
Catania, Italy, 95100
Contact: Carmelita Marcantoni, M.D.    0039 095 726 3378    carmelita.marcantoni@gmail.com   
Contact: Corrado Tamburino, M.D.    0039 095 743 6201    tambucor@unict.it   
Principal Investigator: Corrado Tamburino, M.D.         
Sponsors and Collaborators
Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Investigators
Principal Investigator: Carmelita Marcantoni, M.D. Nephrology Division, Cannizzaro Hospital, Catania, Italy
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carmelita Marcantoni, M.D., Division of Nephrology, Cannizzaro Hospital, Catania
ClinicalTrials.gov Identifier: NCT01173666     History of Changes
Other Study ID Numbers: RC-1
Study First Received: July 30, 2010
Last Updated: July 30, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele:
RAS
LVMI
Renal revascularization

Additional relevant MeSH terms:
Constriction, Pathologic
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hypertrophy
Renal Artery Obstruction
Hypertrophy, Left Ventricular
Pathological Conditions, Anatomical
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Kidney Diseases
Urologic Diseases
Cardiomegaly

ClinicalTrials.gov processed this record on August 21, 2014