Ricerca Finalizzata RFPS-2007-2-634791. Detection, characterization prevention of Major Adverse Cardiac Events after Drug Eluting Stent implantation in patients with Acute Corona- ry Syndrome Dati identificativi del progetto Proposta PS
08 - Sviluppo di nuove strategie conoscitive, diagnostiche, terapeutiche e organiz-zative in pazienti con sindromi coronariche acute
Ente proposta
Regione Lombardia - Direzione Generale Sanità
Durata in mesi Obiettivo principale del progetto
The project is divided into one major study and two correlated studies.
1) Registry of adverse cardiovascular events and stent thrombosis following PCI
Main objective: identification and characterization of all major adverse cardiacevents (MACE) during follow-up after PCI with stent implantation, within a largedynamic multicenter registry including all the PCI procedures performed in the4-million inhabitants Italian region Emilia-Romagna. Incidence, classification ac-cording the Academic Research Consortium definitions, timing, predictors andclinical consequences of stent thrombosis (ST) following BMS or DES implanta-tion will be assessed in patients with ACS (ST-segment elevation myocardial in-farction, STEMI, non-ST-segment elevation myocardial infarction, NSTEMI andunstable angina, UA). In case of angiographic detection of ST an analysis of thethrombosis aspects will be performed taking into account the characteristics of theindex lesion and the technical details of the procedure in which the stent was im-planted. ST and MACE incidence in ACS patients will be compared with that ofpatients treated for stable coronary artery disease.
Secondary objectives: identification of subgroups of patients, based on a combina-tion of clinical, anatomical and procedural factors, which may particularly benefitfrom DES, and patients in whom DES may increase the risk of events
2) Registry of adverse #non coronary# events following Primary PCI for ST-segment elevation myocardial infarction
Main objective: To determine, in the cohort of patients admitted with ST-elevation myocardial infarction undergoing primary PCI, the incidence of adverseevents other than myocardial infarction and new revascularizations, such as heartfailure and heart failure-related events or interventions like major arrhythmias, im-plantation of automatic implantable cardioverter defibrillator (AICD), cardiac re-synchronization therapy (CRT), heart transplant. The study is aimed to evaluatethe clinical implications of heart failure and arrhythmias on mid-term outcome ofthese patients, as compared to the impact of coronary events.
Secondary objective: To identify the clinical and procedural predictors of non co-ronary events during follow-up.
3) Observational study on platelet inhibition with clopidogrel
Main objective: To determine the incidence of resistance to the antiplatelet effectof clopidogrel given at standard dose (75 mg/die) in patients treated for NSTEACS (NSTEMI and UA) for which 1-year double antiplatelet therapy is recom-mended. The presence and the degree of clopidogrel resistance will be correlatedto adverse clinical events and stent thrombosis, in order to evaluate whether or notthis phenomenon is the principal cause of ST. Cofinanziamenti Ente PRIER (Programma per la Ricerca e l'Innovazione dell'Emilia-Romagna in ambito sanitario) Inizio disponibilità 01/06/2008 Importo € 80.000,00 Cofinanziamento totale Costi di unità Operative UO 01 - Agenzia Sanitaria e Sociale Regionale dell'Emilia Romagna di cui a carico di fondi mini- steriali 1. Personale dipendente 2. Personale a contratto/consulenza/borsa di studio 3. Missioni 4. Attrezzature (anche a noleggio) 5. Consumi 6. Pubblicazioni/organizzazione convegni, ecc. 7. Elaborazioni dati, ecc. 8. Spese generali delle strutture coinvolte Note rimodulazione UO 02 - Azienda Ospedaliera Universitaria di Bologna di cui a carico di fondi mini- steriali 1. Personale dipendente 2. Personale a contratto/consulenza/borsa di studio 3. Missioni 4. Attrezzature (anche a noleggio) 5. Consumi 6. Pubblicazioni/organizzazione convegni, ecc. 7. Elaborazioni dati, ecc. 8. Spese generali delle strutture coinvolte Note rimodulazione UO 03 - Azienda OspedalieroUniversitaria di Ferrara di cui a carico di fondi mini- steriali 1. Personale dipendente 2. Personale a contratto/consulenza/borsa di studio 3. Missioni 4. Attrezzature (anche a noleggio) 5. Consumi 6. Pubblicazioni/organizzazione convegni, ecc. 7. Elaborazioni dati, ecc. 8. Spese generali delle strutture coinvolte Note rimodulazione UO 04 - Azienda Ospedaliera di Reggio Emilia di cui a carico di fondi mini- steriali 1. Personale dipendente 2. Personale a contratto/consulenza/borsa di studio 3. Missioni 4. Attrezzature (anche a noleggio) 5. Consumi 6. Pubblicazioni/organizzazione convegni, ecc. 7. Elaborazioni dati, ecc. 8. Spese generali delle strutture coinvolte Note rimodulazione Costi di progetto Costi di coordinamento rimodulati di cui a carico di fondi mini- steriali 1. Personale dipendente 2. Personale a contratto/consulenza/borsa di studio 3. Missioni 4. Attrezzature (anche a noleggio) 5. Consumi 6. Pubblicazioni/organizzazione convegni, ecc. 7. Elaborazioni dati, ecc. 8. Costi di coordinamento 9. Spese generali delle strutture coinvolte Note rimodulazione Costi totali rimodulati di cui a carico di fondi mini- steriali 1. Personale dipendente 2. Personale a contratto/consulenza/borsa di studio 3. Missioni 4. Attrezzature (anche a noleggio) 5. Consumi 6. Pubblicazioni/organizzazione convegni, ecc. 7. Elaborazioni dati, ecc. 8. Costi di coordinamento 9. Spese generali delle strutture coinvolte Note rimodulazione
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