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Clinical Trials/NCT01593865
NCT01593865UnknownNot Applicable

Observational, Case-Control, Propensity-Matched Study of Bilateral Versus Monolateral Internal Mammary Artery Grafting for Severe Coronary Artery Disease. Assessment of Feasibility of Systematic Bilateral Mammary Artery Grafting and Early/Late Clinical Outcomes

Catholic University, Italy1 site in 1 country1,000 target enrollmentStarted: April 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
1,000
Locations
1
Primary Endpoint
Feasibility of systematic BIMA grafting

Study Overview

Brief Summary

The present study hypothesizes that the systematic use of bilateral internal mammary artery (BIMA) grafting is feasible in the practice of a University Cardiac Surgery Institution for the treatment of multivessel coronary artery disease (primary hypothesis). The secondary study hypothesis is that the BIMA grafting meets the safety endpoint compared with the conventional surgical strategy entailing left mammary artery grafting plus great saphenous vein grafts to revascularize the remaining coronary targets. The tertiary study hypothesis is that the BIMA grafting yields better follow-up results in terms of recurrence of symptoms related to coronary disease, of repeat revascularization and of cardiac mortality compared with patients treated with the conventional surgical strategy entailing left mammary artery grafting plus great saphenous vein grafts to revascularize the remaining coronary targets.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patiens undergoing primary or elective-urgent isolated multivessel Coronary Artery Bypass Grafting (CABG) Surgery

Exclusion Criteria

  • Emergency status
  • Previous cardiac operation
  • Any associated cardiac procedure other than CABG Surgery
  • Left Ventricular Ejection Fraction <20%

Outcomes

Primary Outcomes

Feasibility of systematic BIMA grafting

Time Frame: 2012-2014 (2 years)

Starting in June 2012, all clinical data concerning patients undergoing BIMA grafting are recorded, including the baseline demographics and risk factors, the operative time, all in-hospital complications, duration of Intensive care Unit and Hospital stays, the amount of transfusion of blood products.

Secondary Outcomes

  • Clinical results at follow-up(2012-2016 (4 years))

Investigators

Sponsor
Catholic University, Italy
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mario Gaudino

Researcher at Cardiac Surgery University Department

Catholic University, Italy

Study Sites (1)

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