Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-28 @ 5:04 PM
Study NCT ID:
NCT01173666
Status:
UNKNOWN
Last Update Posted:
2010-08-02
First Post:
2010-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stenting of Renal Artery Stenosis in Coronary Artery Disease Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012078', 'term': 'Renal Artery Obstruction'}, {'id': 'D017379', 'term': 'Hypertrophy, Left Ventricular'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044623', 'term': 'Nutrition Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 168}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2011-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-07-30', 'studyFirstSubmitDate': '2010-07-30', 'studyFirstSubmitQcDate': '2010-07-30', 'lastUpdatePostDateStruct': {'date': '2010-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left Ventricular Mass (LVMI, g/m2) changes', 'timeFrame': '1 year', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular mortality and morbidity', 'timeFrame': '5 years'}, {'measure': 'Progression of renal function', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['RAS', 'LVMI', 'Renal revascularization'], 'conditions': ['Renal Artery Stenosis', 'Left Ventricular Hypertrophy']}, 'referencesModule': {'references': [{'pmid': '16049071', 'type': 'BACKGROUND', 'citation': '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': '17488176', 'type': 'BACKGROUND', 'citation': 'Zeller 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': '35224730', 'type': 'DERIVED', 'citation': 'Natale 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': '22495466', 'type': 'DERIVED', 'citation': 'Marcantoni 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nIncidental 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.\n\nThe 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.\n\nStandard 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ischemic heart disease\n* angiographic diagnosis of atherosclerotic RAS \\>50% and ≤80%\n\nExclusion Criteria:\n\n* Atherosclerotic RAS\\>80%\n* RAS secondary to fibromuscular dysplasia\n* AMI\n* single functioning kidney and/or sCr \\>4 mg/dl\n* severe aortic valve stenosis\n* aortic aneurism necessitating surgery'}, 'identificationModule': {'nctId': 'NCT01173666', 'acronym': 'RASCAD', 'briefTitle': 'Stenting of Renal Artery Stenosis in Coronary Artery Disease Study', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'RC-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Drug therapy', 'description': 'Patients will be treated by standard medical therapy.', 'interventionNames': ['Drug: Medical therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Drug therapy + stenting angioplasty', 'description': 'Patients will be treated by standard medical therapy + stenting angioplasty of renal artery.', 'interventionNames': ['Procedure: stenting angioplasty plus medical therapy']}], 'interventions': [{'name': 'stenting angioplasty plus medical therapy', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Drug therapy + stenting angioplasty']}, {'name': 'Medical therapy', 'type': 'DRUG', 'description': 'Patients will be treated by standard medical therapy. Medical therapy is based on antihypertensive, statin or antiplatelet drugs according with clinical indications.', 'armGroupLabels': ['Drug therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95100', 'city': 'Catania', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carmelita Marcantoni, M.D.', 'role': 'CONTACT', 'email': 'carmelita.marcantoni@gmail.com', 'phone': '0039 095 726 3378'}, {'name': 'Corrado Tamburino, M.D.', 'role': 'CONTACT', 'email': 'tambucor@unict.it', 'phone': '0039 095 743 6201'}, {'name': 'Corrado Tamburino, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cardiology Division, University of Catania, Azienda Policlinico-Vittorio Emanuele', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}], 'centralContacts': [{'name': 'Carmelita Marcantoni, M.D.', 'role': 'CONTACT', 'email': 'carmelita.marcantoni@gmail.com', 'phone': '0039 095 7263378'}, {'name': 'Giovanni Tripepi, PhD', 'role': 'CONTACT', 'email': 'gtripepi@ibim.cnr.it', 'phone': '0039 0965 393262'}], 'overallOfficials': [{'name': 'Carmelita Marcantoni, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nephrology Division, Cannizzaro Hospital, Catania, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Carmelita Marcantoni, M.D.', 'oldOrganization': 'Division of Nephrology, Cannizzaro Hospital, Catania'}}}}