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Titolo:
RATIONALE AND METHODOLOGY OF THE ICAI STUDY, A RANDOMIZED CLINICAL-TRIAL OF ALPROSTADIL IN THE TREATMENT OF CHRONIC CRITICAL LEG ISCHEMIA
Autore:
BELGRANO EA; NARDELLA L; GUALA A; MAZZUCCHETTI S; MARINONI V; CALZONI D; BEDONI P; CONFALONIERI MA; AGUS GB; MONDANI P; DEANGELIS R; BIASI GM; PIGLIONICA MR; ABBRITTI F; AGRIFOGLIO G; COSTANTINI A; DELLAVEDOVA MR; MIGLIERINA L; MARROCU R; BRAGHERIO G; ZANONI CE; BORIN F; ALDERI G; EMANUELLI G; FLANDOLI C; COLZANI M; PONTI GB; BERRA S; BEVILACQUA A; BOCCA M; INVERNIZZI C; DEANGELIS E; TACCONI A; DANGELO F; VAGHI M; ARZINI A; BOCCALON L; LOSAPIO GM; AMBROSI R; BRIOLINI F; INZOLI MR; LOMBARDI G; TARANTOLA P; ZOCCA N; TENCHINI P; BRUNI T; FONTANILI M; GUIDETTI D; PEDEFERRI G; BORDONI MC; CATALANO A; VISCONTI W; VEDOVATO F; ZUCCHELLA M; BITTOLO BG; BUSETTO MT; ZAMBON C; CARLASSARA GB; BARBATO O; ZAMBELLI V; MAZZILLI G; LINO M; PAVAN S; PAGNAN A; VISONA A; PERISSINOTTO C; TONIETTO G; MICHELET I; AGRESTA F; FAVRETTI F; BURIGO E; DELAZZER L; GIANSANTE C; FIOTTI N; GREGO S; MOZZON L; GONANO N; PFEIFFER P; PETRILLI GL; PUZZO A; BALDINO G; PODESTA A; GUASTINI A; TRAVERSARO A; ZINICOLA N; BAGLIETTO F; ARNUZZO L; DEFABRITIIS A; FILIPPINI M; FERRARI F; MARTINI L; TESTONI P; ACCORSI F; MAURIZI P; EVANGELISTI G; ROFFI A; MARZARA G; FINI C; COPPI G; CAMPARINI S; TUSINI N; TUSCANO G; LONARDI R; ROZZA A; BOTTA GC; VILLANI LG; PAVARINI E; CAMPANELLA P; MORATTI A; IERAN M; BERTINI D; PRATESI C; NARCETTI S; CORSI C; POLLASTRI M; MARRAPODI E; MELILLO E; IABICHELLA ML; SETACCI C; SOZIO G; CAO P; VERZINI F; MANNARINO E; PASQUALINI L; VAUDO G; ALO F; IOANNIDIS G; SPARTERA C; MARINO G; BAFILE G; ANSELMI E; MANISCALCO G; LONGO P; DIGIOVANNI V; COLLI R; FABBRI MC; BRACALE G; BERNARDO B; PERRETTI B; VALITUTTI P; VIGLIOTTI G; CIMINO G; ROLLI F; PASCALI M; SABELLA G; GRILLI M; CORRERA M; PALESE E; FLORENA M; CASSINA I; CUMBO P; COMANDE C; NOTARBARTOLO A; NOVO S; BELVEDERE M; CARUSO R; VERGHI F; CAVALLARO S; MARTELLO G; ROMEO S; CORMACI OF; BINAGHI F; FRONTEDDU P; CANNAS F; DEGAETANO G; TOGNONI G; AVANZINI F; BERTELE V; DIGIULIO P; PANGRAZZI J; RONCAGLIONI MC; COLOMBO F; FELLIN G; TERZIAN E; COCCHERI S; DELFAVERO A; GERACI E; JANZON L; VERMYLEN J; BEGHI E; COEN D; TURAZZA F;
Indirizzi:
MARIO NEGRI INST PHARMACOL RES,VIA ERITREA 62 I-20157 MILAN ITALY SANTA CORCE HOSP CUNEO ITALY
Titolo Testata:
JN. Journal of nephrology
fascicolo: 2, volume: 9, anno: 1996,
pagine: 93 - 98
SICI:
1121-8428(1996)9:2<93:RAMOTI>2.0.ZU;2-S
Fonte:
ISI
Lingua:
ENG
Soggetto:
MULTICENTER TRIAL; ILOPROST; PROSTACYCLIN;
Keywords:
RANDOMIZED CLINICAL TRIAL; CRITICAL LEG ISCHEMIA; PROSTNOIDS; TRIAL METHODOLOGY;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
15
Recensione:
Indirizzi per estratti:
Citazione:
E.A. Belgrano et al., "RATIONALE AND METHODOLOGY OF THE ICAI STUDY, A RANDOMIZED CLINICAL-TRIAL OF ALPROSTADIL IN THE TREATMENT OF CHRONIC CRITICAL LEG ISCHEMIA", JN. Journal of nephrology, 9(2), 1996, pp. 93-98

Abstract

Objective: to evaluate the safety and efficacy of a stable prostaglandin E(1) added to the usual therapeutic practice (either invasive or not) in patients with chronic critical leg ischemia. Design: multicenter, controlled, randomised, open label trial. Setting: a representativesample (56 centers) of vascular and general surgery, angiology and general medicine departments of the Italian National Health Service. Patients: all patients suffering from leg ischemia considered as chronic and critical depending on the presence of persistently recurring rest pain for more than two weeks and/or foot ulceration or gangrene. Intervention: a daily i.v. infusion of 60 mu g of alprostadil alpha-cyclodextrine for the overall hospital stay, up to a maximum of 28 days (as an adjunct to the standard procedures adopted In each center) to patients randomly assigned to the experimental treatment. Measures: the primary evaluation of efficacy is based on the expected reduction of majoramputations or persistence of critical leg ischemia at six months, The sum of these ''peripheral'' events, of death and of non-fatal myocardial infarction and stroke is used as a more comprehensive evaluation of the risk/benefit profile of the experimental treatment. Results: a reduction from 40% to 32% of the incidence of the primary end-points is the trial hypothesis, The recruitment of 1500 patients is required to verify this. Conclusions: this large-scale trial aims at providing areliable estimate of the possibility of modifying hard end-points such as death and amputation in patients with critical leg ischemia.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 29/11/20 alle ore 06:24:21