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

NCT ID: NCT00755248

Last Updated: 2008-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2011-01-31

Brief Summary

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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

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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.

Conditions

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Myocardial Revascularization Atherosclerosis

Keywords

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Coronary Artery Bypass Grafting (CABG) outcome saphenous graft patency biochemical factors genomics

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Pts undergoing CABG or OPCAB

Coronary Artery Bypass Grafting

Intervention Type PROCEDURE

Coronary Artery Bypass Grafting on- or off-pump

Interventions

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Coronary Artery Bypass Grafting

Coronary Artery Bypass Grafting on- or off-pump

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Cardiologico Monzino

OTHER

Sponsor Role lead

Responsible Party

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Centro Cardiologico Monzino

Principal Investigators

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Alessandro Parolari, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centro Cardiologico Monzino - Milano

Locations

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Centro Cardiologico Monzino

Milan, Milan, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alessandro Parolari, MD, PhD

Role: CONTACT

Phone: 00390258002558

Email: [email protected]

Facility Contacts

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Alessandro Parolari, MD, PhD

Role: primary

References

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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

Reference Type BACKGROUND

Other Identifiers

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BAPPY

Identifier Type: -

Identifier Source: org_study_id