Stenting of Renal Artery Stenosis in Coronary Artery Disease Study
RASCAD
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
1 other identifier
interventional
168
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2006
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 30, 2010
CompletedFirst Posted
Study publicly available on registry
August 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedAugust 2, 2010
July 1, 2010
5 years
July 30, 2010
July 30, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
1 year
Secondary Outcomes (2)
Cardiovascular mortality and morbidity
5 years
Progression of renal function
5 years
Study Arms (2)
Drug therapy
PLACEBO COMPARATORPatients will be treated by standard medical therapy.
Drug therapy + stenting angioplasty
EXPERIMENTALPatients will be treated by standard medical therapy + stenting angioplasty of renal artery.
Interventions
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.
Eligibility Criteria
You may qualify if:
- ischemic heart disease
- angiographic diagnosis of atherosclerotic RAS \>50% and ≤80%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiology Division, University of Catania, Azienda Policlinico-Vittorio Emanuele
Catania, 95100, Italy
Related Publications (4)
Wright JR, Shurrab AE, Cooper A, Kalra PR, Foley RN, Kalra PA. Left ventricular morphology and function in patients with atherosclerotic renovascular disease. J Am Soc Nephrol. 2005 Sep;16(9):2746-53. doi: 10.1681/ASN.2005010043. Epub 2005 Jul 27.
PMID: 16049071BACKGROUNDZeller T, Rastan A, Schwarzwalder U, Muller C, Frank U, Burgelin K, Sixt S, Schwarz T, Noory E, Neumann FJ. Regression of left ventricular hypertrophy following stenting of renal artery stenosis. J Endovasc Ther. 2007 Apr;14(2):189-97. doi: 10.1177/152660280701400211.
PMID: 17488176BACKGROUNDNatale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
PMID: 35224730DERIVEDMarcantoni C, Zanoli L, Rastelli S, Tripepi G, Matalone M, Mangiafico S, Capodanno D, Scandura S, Di Landro D, Tamburino C, Zoccali C, Castellino P. Effect of renal artery stenting on left ventricular mass: a randomized clinical trial. Am J Kidney Dis. 2012 Jul;60(1):39-46. doi: 10.1053/j.ajkd.2012.01.022. Epub 2012 Apr 10.
PMID: 22495466DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carmelita Marcantoni, M.D.
Nephrology Division, Cannizzaro Hospital, Catania, Italy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 30, 2010
First Posted
August 2, 2010
Study Start
April 1, 2006
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
August 2, 2010
Record last verified: 2010-07