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Clinical Trials/NCT00755248
NCT00755248
Unknown
Not Applicable

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

Centro Cardiologico Monzino1 site in 1 country300 target enrollmentJanuary 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocardial Revascularization
Sponsor
Centro Cardiologico Monzino
Enrollment
300
Locations
1
Last Updated
17 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 2007
End Date
January 2011
Last Updated
17 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centro Cardiologico Monzino

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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