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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06316128
Other study ID # K26
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2024
Est. completion date March 15, 2024

Study information

Verified date June 2024
Source Heart Care Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This registry has the aim to assess the use of different antithrombotic therapies, including untested drug combinations, routinely used during the hospitalization phase, with their timing, route and dose of administration, in consecutive patients discharged with a diagnosis NSTEMI or STEMI in Italian Cardiac care Units (CCUs) during a four-week study period.


Description:

EYESHOT-2 is a prospective, multicenter, observational, nationwide survey of patients discharged with a diagnosis NSTEMI or STEMI admitted to Italian CCUs. The survey will be designed to include all consecutive patients, who met the eligibility criteria, admitted in hospitals with or without cardiac catheterization laboratories and cardiac surgery facilities during a period of 4 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 2806
Est. completion date March 15, 2024
Est. primary completion date February 29, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All consecutive patients aged 18 years or more, discharged with diagnosis of myocardial infarction (NSTEMI or STEMI) admitted to CCUs undergoing myocardial revascularization (PCI or CABG) or conservative treatment. At presentation, the diagnosis of NSTEMI will be based on the measurement of troponins and assessment of ECG changes, as suggested by European Society of Cardiology (ESC) guidelines; the diagnosis of STEMI will be characterized by an acute chest pain and persistent (>20 min) ST-segment elevation = 1mm in two or more limb leads, or contiguous pre-cordial leads or left bundle branch block. - Written informed consent signed. Patients who cannot provide the informed consent due to very severe clinical conditions can give their consent some hours/days after admission, when more favourable clinical conditions allow them to receive the appropriate information. Patients having died before giving informed consent may also be included unless the local Institutional Review Board (IRB) does not allow this procedure. In that case, it is strongly suggested to obtain relative(s) agreement through the collect of a signed informed consent. Exclusion Criteria: - Patients with a diagnosis of Unstable Angina, - Patients developing MI after PCI or CABG, - MI following non-cardiac surgery or traumatic causes, - Patients with chest pain without elevation of troponin, - Patients enrolled in Randomized Controlled Trial (RCTs), - Patients already enrolled into the study from another CCU

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Ospedale Miulli - U.O.C. Cardiologia - Utic Acquaviva Delle Fonti BA
Italy Ospedale Della Murgia - Fabio Perinei - S.C. Cardiologia-Utic Altamura BA
Italy Irccs Inrca - Uo Cardiologia/Utic/Telecardiologia Ancona AN
Italy Ospedali Riuniti - Sod Cardiologia Ospedaliera E Utic Ancona AN
Italy Ospedale San Donato - U.O.C Cardiologia Arezzo AR
Italy Ospedale Dei Castelli - U.O.C. Di Cardiologia E Utic Ariccia RM
Italy Ospedale Civile - U.O.C. Di Cardiologia Arzignano VI
Italy Ospedale E. Muscatello - U.O. Di Cardiologia - Utic Augusta SR
Italy Aorn San Giuseppe Moscati - U.O. Cardiologia/Utic 'D. Rotiroti' Avellino AV
Italy Presidio Ospedaliero Moscati - U.O.C. Cardiologia-Utic Aversa CE
Italy Ospedale G. Di Maria - Cardiologia Utic Avola SR
Italy Ospedale Santa Maria Annunziata - Sos Cardiologia Clinica Bagno A Ripoli FI
Italy Aou Policlinico - Uoc Cardiologia Ospedaliera Bari BA
Italy Ospedale San Paolo - Cardiologia-Utic Bari BA
Italy Ospedale Di Bentivoglio - U.O. Cardiologia Pianura Bentivoglio BO
Italy Humanitas Gavazzeni - U.O. Cardiologia Bergamo MI
Italy Ospedale Maggiore - U.O.C. Di Cardiologia Bologna BO
Italy Ospedale Policlinico S. Orsola-Malpighi - U.O. Cardiologia-Galie' Bologna BO
Italy Ospedale Centrale Bolzano - Cardiologia E Prove Funzionali Bolzano BZ
Italy Ospedale Ss. Trinita' - S.C. Di Cardiologia Borgomanero
Italy Ospedale Civile Di Boscotrecase - Utic Cardiologia Boscotrecase
Italy Asst Spedali Civili - Cardiologia Brescia BS
Italy Ospedale Perrino - U.O.C. Di Cardiologia Brindisi BR
Italy Arnas G. Brotzu - Cardiologia Con Utic Cagliari CA
Italy Nuovo Ospedale Versilia - Sc Cardiologia Camaiore LU
Italy Ospedale A. Cardarelli - U.O. Cardiologia E Utic Campobasso CB
Italy Ospedale Di Venere - U.O.C. Di Cardiologia Carbonara Di Bari BA
Italy Ospedale Santo Spirito - Sc Cardiologia Casale AL
Italy Azienda Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia D'Emergenza Con Utic Caserta CE
Italy Ospedale San Leonardo - U.O. Di Cardiologia-Utic Castellammare Di Stabia
Italy Ospedale Di Castellaneta - S.C. Cardiologia Castellaneta TA
Italy Ospedale Santa Croce - Uosd Cardiologia E Di Continuita Assist. Castelnuovo Di Garfagnana LU
Italy P.O. "Pugliese" - A.O.U. "Renato Dulbecco" - Utic-Emodinamica E Cardiologia Interventistica Catanzaro CZ
Italy Ospedale S. Maria Incoronata Dell'Olmo - U.O.C. Cardiologia-Utic Cava De' Tirreni SA
Italy Ospedale Civile Bassa Val Di Cecina - Unita Operativa Di Cardiologia E Utic Cecina LI
Italy Fondazione G. Giglio - U.O. Di Cardiologia Cefalu' PA
Italy Ospedale Di Cernusco Sul Naviglio - U. O. Di Cardiologia E Ucc Cernusco Sul Naviglio MI
Italy Ospedale M. Bufalini - U.O. Di Cardiologia-Utic Cesena FC
Italy Asst Franciacorta - Presidio Chiari - Cardiologia/Utic Chiari BS
Italy Ospedale Policlinico Ss. Annunziata - Uoc Cardiologia-Utic Chieti CH
Italy Ospedale Civico - Sc Cardiologia Chivasso TO
Italy Ospedale Edoardo Bassini - Sc Cardiologia-Ucc Asst Nord Milano (Bassini-Ssg) Cinisello Balsamo MI
Italy Por Cirie'- Lanzo Presidio Cirie' - S.C. Cardiologia Cirié TO
Italy Presidio Ospedaliero Citta' Di Castello - U.O. Cardiologia/Utic Citta' Di Castello PG
Italy Presidio Osp. Di Civitanova Marche - Sc Cardiologia Civitanova Marche MC
Italy Ospedale Maggiore - U.O. Cardiologia E Utic Crema CR
Italy Azienda Ospedaliera Santa Croce E Carle - Sc Cardiologia Cuneo CN
Italy Ospedale Di Desenzano Del Garda - Divisione Di Cardiologia - U.C.C. Desenzano Del Garda BS
Italy Ospedale Pio Xi - U.O.C. Di Cardiologia Desio MB
Italy Ospedale San Biagio - Soc Cardiologia Vco Domodossola VB
Italy Ospedale Maria Ss. Addolorata - U.O. Di Cardiologia Utic Eboli SA
Italy Ospedale San Giuseppe - Cardiologia Empoli FI
Italy Po S. Antonio Abate Di Trapani - U.O.C. Di Cardiologia, Utic Ed Emodinamica Erice TP
Italy Presidio Ospedaliero "Santa Maria Del Prato" - U.O.C. Di Cardiologia-Utic Feltre BL
Italy Arcispedale Sant'Anna - U.O. Cardiologia Ferrara FE
Italy Ospedale Civile - U.O.C. Cardiologia - Utic Fidenza PR
Italy Aou Careggi - Interventistica Cardiologica Strutturale Firenze FI
Italy Ospedale Santa Maria Nuova - Cardiologia Firenze FI
Italy Policlinico Riuniti - S.C. Di Cardiologia Universitaria-Utic Foggia FG
Italy Nuovo Ospedale San Giovanni Battista - S.C. Cardiologia Foligno PG
Italy Ospedale G.B. Morgagni - L. Pierantoni - U.O. Cardiologia Forli' FC
Italy Ospedale San Giovanni Di Dio - Uo Cardiologia - Utic Frattamaggiore
Italy Ospedale Civile 'La Memoria' - U.O. Di Cardiologia Gavardo BS
Italy Ospedale Padre Antero Micone - Sc Cardiologia - Utic Genova GE
Italy Ospedale Villa Scassi - Asl 3 Ligure - Sc Cardiologia Utic Genova GE
Italy Presidio Ospedaliero San Giugliano - U.O. Cardiologia - Utic Giugliano in Campania
Italy Ospedale Moriggia Pelascini - Unita' Operativa Di Cardiologia Gravedona CO
Italy Ospedale Civile Di Guastalla - Sos Cardiologia E Riabilitazione Card Area Nord Guastalla RE
Italy Ospedale Gubbio-Gualdo Tadino - U.O. Di Utic E Cardiologia Gubbio PG
Italy Ospedale Civile - S.C. Cardiologia Ivrea
Italy Ospedale S. Andrea - S.C. Cardiologia La Spezia SP
Italy Ospedale Anna Rizzoli - Cardiologia-Utic Lacco Ameno
Italy Ospedale Del Tigullio Polo Lavagna - Sc Cardiologia E Utic Lavagna GE
Italy Ospedale Vito Fazzi - Uoc Cardiologia-Utic Ed Emodinamica Lecce LE
Italy Asst Ovest Milanese - Po Di Legnano - Cardiologia E Unita' Coronarica Legnano MI
Italy P.O. Lentini - Uosd Di Cardiologia Con Utic Lentini SR
Italy Ospedali Riuniti - U.O.C. Cardiologia E Utic Livorno LI
Italy Ospedale Maggiore Di Lodi - U.O.C. Cardiologia Lodi LO
Italy Ospedale Civile - Uo Servizio Cardiologia Lugo RA
Italy Casa Di Cura San Michele - Uo Cardiologia Maddaloni CE
Italy Ospedale Civile Fornaroli - U.O. Cardiologia Magenta MI
Italy Ospedale Apuane - U.O. Cardiologia-Utic Massa MS
Italy Ospedale Madonna Delle Grazie - Ssd Utic Matera Mount
Italy Osp Abele Ajello - U.O.C. Cardiologia Con Utic Mazara Del Vallo TP
Italy Ospedale San Leopoldo Mandic - Cardiologia - Ucc Merate LC
Italy Irccs Centro Neurolesi Bonino Pulejo - P.O. Piemonte - Cardiologia E Utic Messina ME
Italy Ospedale Dell'Angelo - U.O.C. Cardiologia Mestre VE
Italy Asst Ospedale Metropolitano Niguarda - Cardiologia 1 - Emodinamica Milano MI
Italy ASST SANTI PAOLO E CARLO - PO San Carlo - CARDIOLOGIA-UCC Milano MI
Italy Centro Cardiologico Monzino Irccs - Terapia Intensiva Cardiologica (Utic) Milano MI
Italy Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico - Uoc Malattie Cardiovascolari Milano MI
Italy Ospedale L. Sacco - Sc Cardiologia Milano MI
Italy Ospedale San Luca Irccs - Istituto Auxologico - Area Critica Cardiologica Milano MI
Italy Presidio Ospedaliero Di Mirano - U.O.C. Di Cardiologia Mirano VE
Italy Ospedale Civile Di Baggiovara - U.O. Di Cardiologia Modena MO
Italy Ospedale Santa Croce - Cardiologia Moncalieri TO
Italy A.O.U. Cagliari Policlinico Monserrato - Sc Cardiologia Utic Emodinamica Monserrato CA
Italy Ospedale San Valentino - U.O.C. Cardiologia Montebelluna TV
Italy Ospedale Valdarno S. Maria Della Gruccia - U.O. Malattie Cardiovascolari Montevarchi AR
Italy Fondazione Irccs San Gerardo Dei Tintori - Ospedale San Gerardo - U.O.C. Cardiologia Monza MB
Italy Aorn Cardarelli - U.O. Cardiologia Con Utic Napoli
Italy Aorn Ospedale Dei Colli - P.O. Monaldi - Uoc Cardiologia-Utic Napoli
Italy Ospedale Dei Pellegrini - Uoc Cardiologia-Utic Napoli
Italy Ospedale Del Mare - U.O. Cardiologia Con Utic-Emodinamica Napoli
Italy Presidio Ospedaliero Umberto I - Uoc Cardiologia - Utic Nocera Inferiore SA
Italy Pres. Ospedaliero S. Maria Della Pieta' - U.O. Cardiologia E Utic Nola
Italy Aou Maggiore Della Carita' - Scdo Cardiologia Ii Novara
Italy Ospedale San Francesco - Cardiologia - Utic Nuoro NU
Italy Ospedale Giovanni Paolo Ii - Utic - Cardiologia Olbia OT
Italy Istituto Clinico San Rocco - Unita' Operativa Di Cardiologia OME BS
Italy Aou San Luigi Gonzaga - S.C.D.O. Cardiologia Orbassano TO
Italy Aor Villa Sofia-Cervello P.O. Cervello - U.O. Cardiologia - Cervello Palermo PA
Italy Aor Villa Sofia-Cervello Po Villa Sofia - Uoc Cardiologia E Utic E Emodinamica -Villa Sofia Palermo PA
Italy Aou Policlinico P. Giaccone - U.O.C. Cardiologia Palermo PA
Italy Arnas P.O. Civico E Benfratelli - Uoc Utic Palermo PA
Italy Maria Eleonora Hospital - Cardiologia Palermo PA
Italy Ospedale G.F. Ingrassia - Cardiologia - Utic Palermo PA
Italy Azienda Ospedaliera Universitaria Parma - U.O.C. Di Cardiologia Parma PR
Italy Fondazione Irccs Policlinico San Matteo - Uoc Cardiologia 1 Pavia PV
Italy Azienda Ospedaliera Di Perugia - S.C. Cardiologia Perugia PG
Italy Presidio Ospedaliero San Salvatore - Cardiologia E Utic Pesaro PU
Italy Ospedale Civile Dello Spirito Santo - Cardiologia Con Utic Pescara PE
Italy Ospedale Ss. Cosma E Damiano - Sos Cardiologia Pescia Point
Italy Ospedale Civile 'Guglielmo Da Saliceto' - Uoc Cardiologia E Utic Piacenza PC
Italy Po Ponente - Ospedale Santa Corona - Sc Cardiologia Ponente Pietra Ligure SV
Italy Ospedale Villamarina - Cardiologia E Utic Piombino Elba Piombino LI
Italy Ftgm - Stabilimento Di Pisa - Cardiologia E Medicina Cardiovascolare Pisa PI
Italy Ospedale San Jacopo - Soc Cardiologia Pistoia Point
Italy Ospedale Dell'Alta Val D'Elsa - Uosd Cardiologia-Utic Poggibonsi SI
Italy Presidio Ospedaliero Luigi Curto - Uo Cardiologia-Utic Polla SA
Italy Ospedale Degli Infermi - Sc Di Cardiologia Ponderano BI
Italy Aor San Carlo - Ospedale San Carlo - Ssd Terapia Intensiva Cardiologica Potenza PZ
Italy Ospedale Santa Maria Delle Grazie - U.O. Cardiologia - Utic Con Emodinamica Pozzuoli
Italy Ospedale Santo Stefano - U.O. Cardiologia Prato PO
Italy Ospedale Giovanni Paolo Ii - U.O.C. Cardiologia-Utic Ragusa RG
Italy Ospedale Civile Santa Maria Delle Croci - Uoc Cardiologia Ravenna RA
Italy Grande Ospedale Metropolitano - Osp Riuniti Bianchi Melacrino - Uoc Cardiologia E Utic Reggio Calabria RC
Italy Po Santa Maria Nuova - Ausl Re Irccs - Soc Cardiologia Ospedaliera Reggio Emilia RE
Italy Ospedale Civile - Unita' Operativa Di Cardiologia RHO MI
Italy P.O. San Camillo de Lellis - U.O.C. Cardiologia Rieti RI
Italy Ospedale Infermi - U.O. Cardiologia Rimini RN
Italy Ospedale Degli Infermi - Sc Cardiologia Rivoli TO
Italy Aurelia Hospital - U.O.C Cardiologia Roma RM
Italy European Hospital - U.O.C. Cardiologia Interventistica Roma RM
Italy Ospedale Isola Tiberina - Uoc Cardiologia Diagnostica Interventistica-Utic Roma RM
Italy Ospedale Madre Giuseppina Vannini - U.O.C. Cardiologia Roma RM
Italy Ospedale San Camillo - Uoc Cardiologia Roma RM
Italy Ospedale Sandro Pertini - Uoc Cardiologia Roma RM
Italy Ospedale Santo Spirito - Uoc Cardiologia Roma RM
Italy Policlinico Casilino - U.O.C. Cardiologia Roma RM
Italy Istituto Clinico Humanitas - Irccs - Cardiologia Clinica, Interventistica E Ucc Rozzano MI
Italy Aou S. Giovanni Di Dio-Ruggi D'Aragona - Ssd Utic Salerno SA
Italy Ospedale G. Fracastoro - U.O.C. Di Cardiologia San Bonifacio VR
Italy Ospedale Civile - U.O.C. Di Cardiologia San Dona' Di Piave VE
Italy Irccs Policlinico San Donato - U.O. Cardiologia Con Utic San Donato Milanese MI
Italy Ospedale Nostra Signora Di Bonaria - U.O.C. Cardiologia E Utic San Gavino Monreale SU
Italy Ospedale Casa Sollievo Della Sofferenza - Cardiologia - Utic - Riabil Cardiologica San Giovanni Rotondo FG
Italy Presidio Ospedaliero - U.O. Cardiologia Sanremo IM
Italy Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia Utic Santa Maria Capua Vetere CE
Italy Presidio Ospedaliero Di Saronno - U.O.C. Di Cardiologia Saronno VA
Italy Ospedale Ss. Annunziata - Cardiologia Clinica Ed Interventistica Sassari SS
Italy Ospedale Di Sassuolo - Cardiologia Sassuolo MO
Italy P.O. Levante - Ospedale San Paolo - S.C. Cardiologia Levante Savona SV
Italy Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic "E. Vilei" Scorrano LE
Italy Ospedale Bolognini - Cardiologia E Unita' Coronarica Seriate BG
Italy Presidio Ospedaliero San Rocco - U.O.C. Cardiologia - Utic Sessa Aurunca CE
Italy Irccs Policlinico Multimedica - Uo Di Cardiologia Sesto San Giovanni MI
Italy Aou Senese Ospedale S. Maria Alle Scotte - Cardiologia Siena SI
Italy Casa Di Cura Villa Verde - Cardiologia Taranto TA
Italy Ospedale Ss. Annunziata - S.C. Cardiologia-Utic Taranto TA
Italy Ospedale San Giovanni Evangelista - U.O.C. Di Cardiologia - Utic Tivoli RM
Italy Aou Citta' Della Salute E Della Scienza - S.C. Cardiologia U Torino To
Italy Ospedale Maria Vittoria - Cardiologia (Mrt-Mv) Torino TO
Italy Ospedale Martini - Cardiologia (Mrt-Mv) Torino TO
Italy Ospedale Mauriziano Umberto I - Sc Cardiologia Torino TO
Italy Ospedale San Giovanni Bosco - Sc Cardiologia Torino TO
Italy Ospedale Santa Chiara - Divisione Di Cardiologia Trento TN
Italy Ospedali Treviglio-Caravaggio - Cardiologia Treviglio BG
Italy Ospedale Ca' Foncello - U.O.C. Cardiologia Treviso TV
Italy Azienda Osp. Cardinale G. Panico - U.O. Cardiologia - Utic Tricase LE
Italy Pou "Santa Maria Della Misericordia" - S.O.C. Cardiologia Udine UD
Italy Ospedale San Luca - U.O. Utic - Cardiologia Vallo Della Lucania SA
Italy Ospedale Castelli - Soc Cardiologia Vco Verbania VB
Italy Ospedale Pietro E Michele Ferrero - Cardiologia E Utic Verduno CN
Italy Aoui Di Verona - U.O. Cardiologia Verona VR
Italy Ospedale Civile San Bortolo - U.O.C. Cardiologia Vicenza VI
Italy Nuovo Ospedale Di Vimercate - S.C. Cardiologia E Utic Vimercate MB
Italy Ospedale Belcolle - Uosd Utic Polo Viterbo VT
Italy Ospedale Civile - U.O. Di Cardiologia Voghera PV

Sponsors (1)

Lead Sponsor Collaborator
Heart Care Foundation

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Other Assessment of in-hospital clinical events An exploratory objective is the assessment of the rate of in-hospital clinical events (ischemic and hemorrhagic) in a large setting of NSTEMI or STEMI patients admitted to CCUs treated with different revascularization strategies and combinations of antithrombotic agents. 1 week
Primary Antithrombotic therapies The primary objective of the study is to describe at a national level the different antithrombotic therapies (alone or in combination) commonly employed from admission to discharge in NSTEMI or STEMI patients undergoing different therapeutic strategies (PCI, CABG, conservative). A particular focus will be given to antithrombotic therapies (combinations, timing of administration, indications) used (a) before PCI (pre-treatment) (b) in the cath lab during PCI [use of Glycoprotein IIb/IIIa inhibitors (GPIs), cangrelor, anticoagulants] and (c) during hospital stay. 1 week
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