European Unified Registries for Heart Care Evaluation and Randomised Trials Italy (EuroHeart ITA)
European Unified Registries for Heart Care Evaluation and Randomised Trials
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Aldo P Maggioni, MD
- Phone Number: 055/5101361
- Email: maggioni@heartcarefoundation.it
Study Contact Backup
- Name: Furio Colivicchi, MD
- Phone Number: 055/51013741
- Email: euroheart.italia@heartcarefoundation.itON.IT
Study Locations
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Novara, Italy, 28100
- Recruiting
- Aou Maggiore Della Carita' - Ssvd Utic
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Contact:
- Giuseppe Rocco Salvatore Patti, MD
- Phone Number: 00393394296745
- Email: giuseppe.patti@uniupo.it
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AREZZO
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Montevarchi, AREZZO, Italy, 52027
- Recruiting
- Ospedale Valdarno S. Maria Della Gruccia - U.O. Malattie Cardiovascolari
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Contact:
- Giovanni Falsini, MD
- Phone Number: 00393486000920
- Email: giofalsini@gmail.com,giovanni.falsini@uslsudest.toscana.it
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BA
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Acquaviva delle Fonti, BA, Italy, 70021
- Recruiting
- Ospedale Miulli - U.O.C. CARDIOLOGIA - UTIC
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Contact:
- Federica Troisi, MD
- Phone Number: 00393494539015
- Email: federica.troisi@libero.it,f.troisi@miulli.it
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Altamura, BA, Italy, 70022
- Recruiting
- Ospedale Della Murgia - Fabio Perinei - S.C. Cardiologia-Utic
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Contact:
- Angela Potenza, MD
- Phone Number: 00393479934450
- Email: pot.angela@gmail.com,pot.angela@libero.it
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Bari, BA, Italy, 70123
- Recruiting
- Ospedale San Paolo - Cardiologia-Utic
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Contact:
- Cosimo Campanella, MD
- Phone Number: 00393298217131
- Email: cosimocamp@gmail.com
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Bari, BA, Italy, 70131
- Recruiting
- Ospedale Di Venere - U.O.C. Di Cardiologia
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Contact:
- Francesco Cassano, MD
- Phone Number: 00393351545454
- Email: fcassano1980@gmail.com
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BS
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Brescia, BS, Italy, 25123
- Recruiting
- Asst Spedali Civili - Cardiologia
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Contact:
- Elio Gorga
- Phone Number: 00393929448005
- Email: eliogorga@yahoo.it
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CAGLIARI
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Monserrato, CAGLIARI, Italy, 09124
- Active, not recruiting
- A.O.U. Cagliari Policlinico Monserrato - Sc Cardiologia Utic Emodinamica
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CATANIA
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Catania, CATANIA, Italy, 95126
- Recruiting
- Azienda Ospedaliera Cannizzaro - Uoc Cardiologia
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Contact:
- Francesco Amico, MD
- Phone Number: 00393389050175
- Email: famico64@gmail.com
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CB
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Campobasso, CB, Italy, 86100
- Recruiting
- Ospedale A. Cardarelli - U.O. Cardiologia E Utic
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Contact:
- Angela Rita Colavita, MD
- Phone Number: 00393392524959
- Email: angelarita.colavita@email.it,angelarita.colavita@asrem.org
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CE
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Caserta, CE, Italy, 81100
- Recruiting
- Azienda Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia D'Emergenza Con Utic
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Contact:
- Paolo Calabrò, MD
- Phone Number: 00393284346963
- Email: paolo.calabro@unicampania.it
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Maddaloni, CE, Italy, 81024
- Recruiting
- Casa Di Cura San Michele - Uo Cardiologia
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Contact:
- Marco Pepe, MD
- Phone Number: 00393402275139
- Email: marcpep@hotmail.it
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CR
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Cremona, CR, Italy, 26100
- Active, not recruiting
- Ospedale Di Cremona - Uo Di Cardiologia
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CS
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Castrovillari, CS, Italy, 87012
- Not yet recruiting
- Ospedale Civile Ferrari - U.O.C. Cardiologia-Utic
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Contact:
- Andrea Madeo, MD
- Phone Number: 00393468603653
- Email: andreamadeo83@gmail.com
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Cosenza, CS, Italy, 87100
- Recruiting
- Ospedale Annunziata - Uoc Cardiologia
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Contact:
- Antonio Curcio, MD
- Phone Number: 00393473304858
- Email: curcio@unicz.it,antonio.curcio.cardio@unical.it,antonio.curcio@aocs.it
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CZ
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Catanzaro, CZ, Italy, 88100
- Not yet recruiting
- P.O. "Pugliese" - A.O.U. "Renato Dulbecco" - Utic-Emodinamica E Cardiologia Interventistica
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Contact:
- Vincenzo Antonio Ciconte, MD
- Phone Number: 00393939988521
- Email: enzocico2003@yahoo.it
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FG
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Foggia, FG, Italy, 71100
- Recruiting
- Policlinico Riuniti - S.C. Di Cardiologia Universitaria-Utic
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Contact:
- Natale Daniele Brunetti, MD
- Phone Number: 00393287660350, 00393389112358
- Email: natale.brunetti@unifg.it,natalebrunetti@gmail.com
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FI
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Empoli, FI, Italy, 50053
- Recruiting
- Ospedale San Giuseppe - Cardiologia
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Contact:
- Francesco Calabrò, MD
- Phone Number: 00393496462213
- Email: francecala@virgilio.it,francesco.calabro@uslcentro.toscana.it
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Florence, FI, Italy, 50134
- Active, not recruiting
- Aou Careggi - Interventistica Cardiologica Strutturale
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GE
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Genova, GE, Italy, 16132
- Recruiting
- Irccs Ospedale Policlinico San Martino - Unita' Operativa Cardiologia
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Contact:
- Roberta Della Bona, MD
- Phone Number: 00393479303133
- Email: roberta.dellabona@gmail.com
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MESSINA
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Messina, MESSINA, Italy, 98124
- Recruiting
- Irccs Centro Neurolesi Bonino Pulejo - P.O. Piemonte - Cardiologia E Utic
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Contact:
- Stefania Trifilo', MD
- Phone Number: 00393404749270
- Email: stefaniatrifilo@gmail.com
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Messina, MESSINA, Italy, 98124
- Recruiting
- Policlinico G. Martino U.O.C - Cardiologia Con Utic
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Contact:
- Patrizia Grimaldi, MD
- Phone Number: 00393337168901
- Email: patgrima@alice.it,patrizia.grimaldi@polime.it
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MILANO
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Magenta, MILANO, Italy, 20013
- Recruiting
- Ospedale Civile Fornaroli - U.O. Cardiologia
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Contact:
- Alessandra Russo, MD
- Phone Number: 00393468021501
- Email: alina2007russo@libero.it,alessandra.russo@asst-ovestmi.it
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Milan, MILANO, Italy, 20132
- Not yet recruiting
- Irccs Ospedale San Raffaele - Area Unica Di Terapia Intensiva Cardiologica E Cch
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Contact:
- Vittorio Pazzanese, MD
- Phone Number: 00393332272023
- Email: vittorio.pazzanese@hotmail.it,pazzanese.vittorio@hsr.it
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Milan, MILANO, Italy, 20157
- Active, not recruiting
- Ospedale L. Sacco - Sc Cardiologia
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Mlano
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Milan, Mlano, Italy, 20162
- Active, not recruiting
- Asst Ospedale Metropolitano Niguarda - Cardiologia 1 - Emodinamica
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NAPOLI
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Napoli, NAPOLI, Italy, 80131
- Recruiting
- Aou Federico Ii - Uoc Cardiologia Emodinamica Ed Utic
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Contact:
- Giovanni Esposito, MD
- Phone Number: 00393386000855
- Email: espogiov@unina.it
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PALERMO
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Palermo, PALERMO, Italy, 90127
- Active, not recruiting
- Aou Policlinico P. Giaccone - U.O.C. Cardiologia
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Palermo, PALERMO, Italy, 90146
- Recruiting
- Aor Villa Sofia-Cervello Po Villa Sofia - Uoc Cardiologia E Utic E Emodinamica -Villa Sofia
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Contact:
- Carlo Cicerone, MD
- Phone Number: 00393398482237
- Email: carlo.cicerone@gmail.com,c.cicerone@villasofia.it
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PD
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Padua, PD, Italy, 35128
- Active, not recruiting
- Azienda Ospedale-Universita Padova - Uosd Terapia Intensiva Cardiologica
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PE
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Pescara, PE, Italy, 65124
- Recruiting
- Ospedale Civile Dello Spirito Santo - Cardiologia Con Utic
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Contact:
- Massimo Di Marco, MD
- Phone Number: 00393472505580
- Email: dimarcom@hotmail.com,massimo.dimarco@asl.pe.it
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PG
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Perugia, PG, Italy, 06129
- Not yet recruiting
- Azienda Ospedaliera Di Perugia - S.C. Cardiologia
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Contact:
- Maurizio Del Pinto, MD
- Phone Number: 00393356654474
- Email: maudp134@gmail.com
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PR
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Fidenza, PR, Italy, 43036
- Recruiting
- Ospedale Civile - U.O.C. Cardiologia - Utic
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Contact:
- Giovanni Tortorella, MD
- Phone Number: 00393396604888
- Email: gtortorella@ausl.pr.it
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PU
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Pesaro, PU, Italy, 61121
- Recruiting
- Presidio Ospedaliero San Salvatore - Cardiologia E Utic
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Contact:
- Francesca Terzi, MD
- Phone Number: 00393336181531
- Email: francesca.terzi@sanita.marche.it,francesca.terzi3@gmail.com
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RE
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Reggio Emilia, RE, Italy, 42100
- Recruiting
- Po Santa Maria Nuova - Ausl Re Irccs - Soc Cardiologia Ospedaliera
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Contact:
- Alessandro Navazio, MD
- Phone Number: 00393474535061
- Email: alessandro.navazio@ausl.re.it,a.navazio@iol.it
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RG
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Ragusa, RG, Italy, 97100
- Recruiting
- Ospedale Giovanni Paolo Ii - U.O.C. Cardiologia-Utic
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Contact:
- Antonino Nicosia, MD
- Phone Number: 00393398198339
- Email: antonino.nicosia@asp.rg.it
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RIETI
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Rieti, RIETI, Italy, 02100
- Recruiting
- P.O. San Camillo de Lellis - U.O.C. Cardiologia
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Contact:
- Amir Kol, MD
- Phone Number: 00393398057567, 00393398761877
- Email: a.kol@asl.rieti.it
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RM
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Roma, RM, Italy, 00128
- Not yet recruiting
- Campus Biomedico - Cardiologia
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Contact:
- Rosetta Melfi, MD
- Phone Number: 00393347235885
- Email: r.melfi@policlinicocampus.it
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Roma, RM, Italy, 00135
- Not yet recruiting
- P.O. San Filippo Neri - Asl Roma 1 - Cardiologia Intensiva Ed Interventistica
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Contact:
- Veronica Melita, MD
- Phone Number: 00393334559422
- Email: veronica.melita@gmail.com,veronica.melita@aslroma1.it
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Roma, RM, Italy, 00157
- Not yet recruiting
- Ospedale Sandro Pertini - Uoc Cardiologia - Utic
-
Contact:
- Paolo Trambaiolo, MD
- Phone Number: 00393474473845
- Email: paolo.trambaiolo@gmail.com
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Roma, RM, Italy, 00169
- Not yet recruiting
- Policlinico Casilino - U.O.C. Cardiologia
-
Contact:
- Leonardo Calò, MD
- Phone Number: 00393388589677
- Email: leonardo.calo@icloud.com,leonardocalo.doc@gmail.com
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Roma, RM, Italy, 00177
- Recruiting
- Ospedale Madre Giuseppina Vannini - U.O.C. Cardiologia
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Contact:
- Emanuela Belmonte, MD
- Phone Number: 00393398959555
- Email: ebelmonte.1@gmail.com
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RO
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Rovigo, RO, Italy, 45100
- Recruiting
- Ospedale Santa Maria Della Misericordia - U.O.C. Cardiologia
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Contact:
- Claudio Picariello, MD
- Phone Number: 00393288622957
- Email: claudio.picariello@aulss5.veneto.it
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SA
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Vallo della Lucania, SA, Italy, 84078
- Recruiting
- Ospedale San Luca - U.O. Utic - Cardiologia
-
Contact:
- Antonio Aloia, MD
- Phone Number: 00393333889863
- Email: tonialoia62@gmail.com
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SI
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Siena, SI, Italy, 53100
- Not yet recruiting
- Aou Senese Ospedale S. Maria Alle Scotte - Cardiologia
-
Contact:
- Serafina Valente, MD
- Phone Number: 00393356508192
- Email: seravalente@gmail.com,serafina.valente@ao-siena.toscana.it
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SV
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Savona, SV, Italy, 17100
- Recruiting
- P.O. Levante - Ospedale San Paolo - S.C. Cardiologia Levante
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Contact:
- Alberto Somaschini, MD
- Phone Number: 00393402387386
- Email: alberto.somaschini08@gmail.com
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TO
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Ivrea, TO, Italy, 10015
- Not yet recruiting
- Ospedale Civile - S.C. Cardiologia
-
Contact:
- Enrica Lonni, MD
- Phone Number: 00393403669264
- Email: enrica.lonni@libero.it,lonni.enrica@gmail.com,elonni@aslto4.piemonte.it
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Torino, TO, Italy, 10126
- Recruiting
- Aou Citta' Della Salute E Della Scienza - S.C. Cardiologia U
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Contact:
- Pier Paolo Bocchino, MD
- Phone Number: 00393488670565
- Email: pierpaolo1991@gmail.com
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TRENTO
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Rovereto, TRENTO, Italy, 38068
- Recruiting
- Ospedale Santa Maria Del Carmine - U.O. Cardiologia Ad Indirizzo Elettrofisiologia
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Contact:
- Maurizio Del Greco, MD
- Phone Number: 00393356385963
- Email: maurizio.delgreco@apss.tn.it
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Trento, TRENTO, Italy, 38122
- Recruiting
- OSPEDALE SANTA CHIARA - Divisione di Cardiologia
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Contact:
- Roberto Bonmassari, MD
- Phone Number: 00393457950992, 00393666132146
- Email: roberto.bonmassari@apss.tn.it
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TS
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Trieste, TS, Italy, 34149
- Recruiting
- Asugi - Ospedale Di Cattinara - S.C. Cardiologia
-
Contact:
- Gianfranco Sinagra, MD
- Phone Number: 00393333556032,00393207987915
- Email: gianfranco.sinagra@asugi.sanita.fvg.it
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TV
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Treviso, TV, Italy, 31100
- Recruiting
- Ospedale Ca' Foncello - U.O.C. Cardiologia
-
Contact:
- Carlo Cernetti, MD
- Phone Number: 00393472623082
- Email: carlocernetti@gmail.com,carlocernetti@live.com,carlocernetti@yahoo.it,carlo.cernetti@aulss2.veneto.it
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UD
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Udine, UD, Italy, 33100
- Recruiting
- Pou "Santa Maria Della Misericordia" - S.O.C. Cardiologia
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Contact:
- Massimo Imazio, MD
- Phone Number: 00393296524271
- Email: massimo.imazio@uniud.it
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VARESE
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Saronno, VARESE, Italy, 21047
- Not yet recruiting
- Presidio Ospedaliero Di Saronno - U.O.C. Di Cardiologia
-
Contact:
- Daniele Nassiacos, MD
- Phone Number: 00393384510961
- Email: nassidan@tin.it,daniele.nassiacos@asst-valleolona.it
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VI
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Arzignano, VI, Italy, 36071
- Recruiting
- Ospedale Civile - U.O.C. Di Cardiologia
-
Contact:
- Claudio Bilato, MD
- Phone Number: 00393387105135
- Email: claudio.bilato@aulss8.veneto.it
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VR
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Negrar, VR, Italy, 37024
- Recruiting
- Irccs Ospedale Sacro Cuore Don Calabria - U.O. Di Cardiologia
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Contact:
- GIULIO MOLON, MD
- Phone Number: 00393358373237
- Email: giulio.molon@sacrocuore.it,elettrofisiologo@gmail.com
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Verona, VR, Italy, 37126
- Active, not recruiting
- Aoui Di Verona - U.O. Cardiologia
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients ≥18 years of age.
- Males and females at birth.
- At least one of the following clinical conditions:
- Hospitalization for Acute Coronary Syndrome (ACS)
- Heart failure (HF, outpatients, and/or inpatients)
- Atrial fibrillation (A Fib, outpatients and/or inpatients)
- Signed informed consent for the study and for privacy.
Exclusion Criteria:
- patients who do not sign the consent to participate in the project and/or Privacy
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence to ESC Quality indicators (STEMI patients reperfused)
Time Frame: From enrollment to 12 months follow-up
|
Proportion of patients with STEMI reperfused among those eligible (onset of symptoms to diagnosis <12 hours)
|
From enrollment to 12 months follow-up
|
|
Adherence to ESC Quality indicators (STEMI patients reperfused <90 min)
Time Frame: From enrollment to 12 months follow-up
|
Proportion of patients with STEMI who receive timely reperfusion with PCI (wire crossing) within 90 minutes from initial diagnostic ECG
|
From enrollment to 12 months follow-up
|
|
Adherence to ESC Quality indicators (coronary angiography in NSTEMI patients within 24 hours)
Time Frame: From enrollment to 12 months follow-up
|
Rate of NSTEMI patients who receive invasive within 24 hours from their diagnosis
|
From enrollment to 12 months follow-up
|
|
Adherence to ESC Quality indicators (radial access)
Time Frame: From enrollment to 12 months follow-up
|
Use of radial access in case of invasive strategy for patients with STEMI and NSTEMI
|
From enrollment to 12 months follow-up
|
|
Adherence to ESC Quality indicators (time to reperfusion in STEMI patients)
Time Frame: From enrollment to 12 months follow-up
|
The time between the initial STEMI diagnosis and arterial access (absolute value) for primary PCI
|
From enrollment to 12 months follow-up
|
|
Adherence to ESC Quality indicators (pre-discharge LVEF evaluation in STEMI and NSTEMI patients)
Time Frame: From enrollment to 12 months follow-up
|
The proportion of patients with STEMI and NSTEMI who have an assessment of their left ventricular ejection fraction (LVEF) before hospital discharge
|
From enrollment to 12 months follow-up
|
|
Adherence to ESC Quality indicators (in hospital LDL-c evaluation in STEMI and NSTEMI patients)
Time Frame: From enrollment to 12 months follow-up
|
The proportion of patients with STEMI and NSTEMI who have their LDL cholesterol measured during hospitalization
|
From enrollment to 12 months follow-up
|
|
Adherence to ESC Quality indicators (DAPT prescription at discharge in STEMI and NSTEMI patients)
Time Frame: From enrollment to 12 months follow-up
|
Proportion of patients with STEMI and NSTEMI discharged on dual antiplatelet therapy
|
From enrollment to 12 months follow-up
|
|
Adherence to ESC Quality indicators (LLA prescription at discharge in STEMI and NSTEMI patients)
Time Frame: From enrollment to 12 months follow-up
|
Proportion of patients discharged from hospital on Lipid Lowering Agents (LLA)
|
From enrollment to 12 months follow-up
|
|
Adherence to ESC Quality indicators (ACEi/ARB/ARNI prescription at discharge in patients with LVEF ≤40%)
Time Frame: From enrollment to 12 months follow-up
|
Proportion of patients with LVEF ≤40% who are discharged from hospital on angiotensin converting enzymes inhibitors (ACEi) or angiotensin receptor blockers (ARBs) or angiotensin receptor-neprilysin inhibitor (ARNI)
|
From enrollment to 12 months follow-up
|
|
Adherence to ESC Quality indicators (Beta blockers prescription at discharge in patients with LVEF ≤40%)
Time Frame: From enrollment to 12 months follow-up
|
Proportion of patients with LVEF ≤40% who are discharged from hospital on beta blockers.
|
From enrollment to 12 months follow-up
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiovascular and non-cardiovascular events during follow-up
Time Frame: 12 months follow-up
|
Proportion of patients with clinical events at 12 months
|
12 months follow-up
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
General Publications
- Schiele F, Aktaa S, Rossello X, Ahrens I, Claeys MJ, Collet JP, Fox KAA, Gale CP, Huber K, Iakobishvili Z, Keys A, Lambrinou E, Leonardi S, Lettino M, Masoudi FA, Price S, Quinn T, Swahn E, Thiele H, Timmis A, Tubaro M, Vrints CJM, Walker D, Bueno H; ESC Scientific Document Group; Halvorsen S, Jernberg T, Jortveit J, Blondal M, Ibanez B, Hassager C. 2020 Update of the quality indicators for acute myocardial infarction: a position paper of the Association for Acute Cardiovascular Care: the study group for quality indicators from the ACVC and the NSTE-ACS guideline group. Eur Heart J Acute Cardiovasc Care. 2021 Apr 8;10(2):224-233. doi: 10.1093/ehjacc/zuaa037.
- Batra G, Aktaa S, Camm AJ, Costa F, Di Biase L, Duncker D, Fauchier L, Fragakis N, Frost L, Hijazi Z, Juhlin T, Merino JL, Mont L, Nielsen JC, Oldgren J, Polewczyk A, Potpara T, Sacher F, Sommer P, Tilz R, Maggioni AP, Wallentin L, Casadei B, Gale CP. Data standards for atrial fibrillation/flutter and catheter ablation: the European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart). Eur Heart J Qual Care Clin Outcomes. 2023 Sep 12;9(6):609-620. doi: 10.1093/ehjqcco/qcac068.
- Aktaa S, Batra G, Cleland JGF, Coats A, Lund LH, McDonagh T, Rosano G, Seferovic P, Vasko P, Wallentin L, Maggioni AP, Casadei B, Gale CP; Heart Failure Association of the European Society of Cardiology. Data standards for heart failure: the European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart). Eur Heart J. 2022 Jun 14;43(23):2185-2195. doi: 10.1093/eurheartj/ehac151.
- Association of Cardiovascular Nursing and Allied Professions (ACNAP); Association for Acute CardioVascular Care (ACVC); European Association of Percutaneous Cardiovascular Interventions (EAPCI); EURObservational Research Programme (EORP); ESC Patient Forum; ESC Working Group on Thrombosis and ESC Committee for Young Cardiovascular Professionals; Batra G, Aktaa S, Wallentin L, Maggioni AP, Ludman P, Erlinge D, Casadei B, Gale CP. Data standards for acute coronary syndrome and percutaneous coronary intervention: the European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart). Eur Heart J. 2022 Jun 21;43(24):2269-2285. doi: 10.1093/eurheartj/ehac133.
- Aktaa S, Batra G, Wallentin L, Baigent C, Erlinge D, James S, Ludman P, Maggioni AP, Price S, Weston C, Casadei B, Gale CP. European Society of Cardiology methodology for the development of quality indicators for the quantification of cardiovascular care and outcomes. Eur Heart J Qual Care Clin Outcomes. 2022 Jan 5;8(1):4-13. doi: 10.1093/ehjqcco/qcaa069.
- Wallentin L, Gale CP, Maggioni A, Bardinet I, Casadei B. EuroHeart: European Unified Registries On Heart Care Evaluation and Randomized Trials. Eur Heart J. 2019 Sep 1;40(33):2745-2749. doi: 10.1093/eurheartj/ehz599. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- K27
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.