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Coronary Artery Bypass Grafting: Factors Related to Late Events and Saphenous Graft Patency
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Milan, Italië, 20138
- Werving
- Centro Cardiologico Monzino
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Contact:
- Alessandro Parolari, MD, PhD
- Telefoonnummer: 00390258002558
- E-mail: alessandro.parolari@ccfm.it
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Hoofdonderzoeker:
- Alessandro Parolari, MD, PhD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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1
Pts undergoing CABG or OPCAB
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Coronary Artery Bypass Grafting on- or off-pump
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Alessandro Parolari, MD, PhD, Centro Cardiologico Monzino - Milano
Publicaties en nuttige links
Algemene publicaties
- 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
Studie record data
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Studie start
Studie voltooiing (Verwacht)
Studieregistratiedata
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- BAPPY
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Klinische onderzoeken op Coronary Artery Bypass Grafting
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EgymedicalpediaVoltooidCoronaire bypassoperatie | Coronaire Bypass StenoseEgypte
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University of WuerzburgDeutsche Stiftung für HerzforschungOnbekendHartinfarct | Coronaire hartziekte | HerseninfarctDuitsland
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CoRepair, Inc.Beëindigd
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Aesculap AGB.Braun Surgical SAVoltooidCoronaire hartziekte | Meervats coronaire hartziektePortugal, Spanje, Duitsland, Italië
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Population Health Research InstituteCharles University, Czech Republic; Centre hospitalier de l'Université de Montréal... en andere medewerkersVoltooidde werkzaamheid en veiligheid van off-pump CABGCanada, China, Colombia, Indië, Chili, Argentinië, Brazilië, Tsjechische Republiek, Frankrijk, Italië, Polen, Kalkoen, Verenigd Koninkrijk
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University Hospital, Basel, SwitzerlandVoltooidComplicatie van coronaire bypass-transplantaat | Complicatie van extracorporale circulatieZwitserland
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Yonsei UniversityOnbekendCoronaire hartziekte, diabetesKorea, republiek van
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Brigham and Women's HospitalNano-X Imaging LimitedNog niet aan het wervenCoronaire hartziekteVerenigde Staten