- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00755248
Coronary Artery Bypass Grafting: Factors Related to Late Events and Saphenous Graft Patency
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Coronary artery bypass grafting represents one of the most frequent surgical procedure performed in the United States and Europe. The clinical benefit of myocardial revascularization is related to freedom of adverse cardiovascular events and to graft patency, above all of great saphenous vein, which is nowadays the main autologous vessel used for grafting coronaries different from anterior interventricular artery. Unfortunately, phenomena leading to early and, above all, late complications and to graft occlusion are not fully clarified and it so not possible to explain interindividual and temporary variability of progressive stenosis rate only on the basis of classical atherosclerosis risk factors. The aim of our study is to prospectively study the role of conventional risk factors (preoperative risk factors and clinical features) and of unconventional risk factors (genetic polymorphisms, inflammation and coagulation markers) with saphenous late patency and postoperative patients outcome, in particular with regard to adverse clinical events (myocardial infarction, successive stenting procedures, arrhythmias etc.)and to bypass patency.
Plasma venous samples will be collected the day before surgery, at discharge from the hospital, and at follow-up from patients undergoing on-pump and off-pump coronary artery bypass grafting and stored at -80°C; Patients will be followed-up periodically with visits and telephone interviews, and will be also invited to undergo multislice (64 rows) CT scan in order to assess graft patency between 12 and 24 months after surgery.
Finally the relation between conventional and unconventional risk factors with adverse events at follow-up will be assessed with multivariable statistical models.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Contatto studio
- Nome: Alessandro Parolari, MD, PhD
- Numero di telefono: 00390258002558
- Email: alessandro.parolari@ccfm.it
Luoghi di studio
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Milan, Italia, 20138
- Reclutamento
- Centro Cardiologico Monzino
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Contatto:
- Alessandro Parolari, MD, PhD
- Numero di telefono: 00390258002558
- Email: alessandro.parolari@ccfm.it
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Investigatore principale:
- Alessandro Parolari, MD, PhD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Men and women age 18 to 89
- Elective primary CABG
- Female patients must be non-lactating and not pregnant
- Able and willing to comply with study requirements by signing a consent form
Exclusion criteria
- Concomitant surgery
- Major end organ dysfunction
- Serious intercurrent illness or infection
- Known coagulation disorders
- Emergencies
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
---|---|
1
Pts undergoing CABG or OPCAB
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Coronary Artery Bypass Grafting on- or off-pump
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Alessandro Parolari, MD, PhD, Centro Cardiologico Monzino - Milano
Pubblicazioni e link utili
Pubblicazioni generali
- 1. American Heart Association. Heart disease and stroke statistics - 2005 update. Dallas, TX: AHA 2004 2. Lytle BW. Prolonging patency - choosing coronary bypass grafts. N Engl J Med 2004; 351: 2262-4 3. Motwani JG et al. Aortocoronary saphenous vein graft disease : pathogenesis, predisposition and prevention. Circulation 1998; 97:916-31 4. Yilmaz M et al. Metabolic syndrome negatively impacts early patency of saphenous vein grafts. Coronary artery disease 2006; 17:41-4 5. Moor E et al. Haemostatic function in patients undergoing coronary artery bypass grafting: perioperative perturbations and relations to saphenous vein graft closure. Thrombosis research 2000; 98:39-49 6. Podgoreanu M et al. New paradigms in cardiovascular medicine. JACC 2005; 46:1965-77 7. Stafford-Smith M et al. Association of genetic polymorphisms with risk of renal injury after coronary bypass graft surgery. Am J Kidney Dusease 2005; 45:519-30 8. Moor E et al. Coagulation factor V (Arg506à Gln) mutation and early saphenous graft occlusion after coronary artery bypass grafting. Thromb Haemost 1998; 80:220-4 9. Yende S et al. Clinical relevance of ACE gene polymorphisms topredict risk of mechanical ventilation after coronary artery bypass surgery. Crit Care Med 2004; 32: 922-27
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Primo Inserito (Stima)
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BAPPY
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