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Coronary Artery Bypass Grafting: Factors Related to Late Events and Saphenous Graft Patency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00755248
Recruitment Status : Unknown
Verified September 2008 by Centro Cardiologico Monzino.
Recruitment status was:  Recruiting
First Posted : September 18, 2008
Last Update Posted : September 18, 2008
Information provided by:
Centro Cardiologico Monzino

Brief Summary:
The purpose of this study is to determine the relations between conventional and unconventional risk factors and adverse clinical events at follow-up (including coronary bypass patency) in patients undergoing surgical myocardial revascularization.

Condition or disease Intervention/treatment
Myocardial Revascularization Atherosclerosis Procedure: Coronary Artery Bypass Grafting

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Coronary Artery Bypass Grafting: Factors Related to Late Events and Saphenous Graft Patency
Study Start Date : January 2007
Estimated Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Pts undergoing CABG or OPCAB
Procedure: Coronary Artery Bypass Grafting
Coronary Artery Bypass Grafting on- or off-pump

Biospecimen Retention:   Samples With DNA
Plasma,serum, whole blood

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00755248

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Contact: Alessandro Parolari, MD, PhD 00390258002558

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Centro Cardiologico Monzino Recruiting
Milan, Italy, 20138
Contact: Alessandro Parolari, MD, PhD    00390258002558   
Principal Investigator: Alessandro Parolari, MD, PhD         
Sponsors and Collaborators
Centro Cardiologico Monzino
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Principal Investigator: Alessandro Parolari, MD, PhD Centro Cardiologico Monzino - Milano
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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Responsible Party: Centro Cardiologico Monzino Identifier: NCT00755248    
Other Study ID Numbers: BAPPY
First Posted: September 18, 2008    Key Record Dates
Last Update Posted: September 18, 2008
Last Verified: September 2008
Keywords provided by Centro Cardiologico Monzino:
Coronary Artery Bypass Grafting (CABG)
saphenous graft patency
biochemical factors
Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases