The Catholic University BIMA Grafting Study

• Conditions: Multivessel Coronary Artery Disease
• Interventions: Procedure: BIMA Grafting; Procedure: Left-only mammary artery grafting

• Registration Number: NCT01593865
• Lead Sponsor: Catholic University, Italy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-05-05
• Study First Submitted QC: 2012-05-07
• Study First Posted: 2012-05-08
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-17
• Last Update Posted: 2012-08-21
• Primary Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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%

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BIMA Grafting Group	BIMA Grafting	Group consists of patients who received bilateral internal mammary artery grafting for treatment of severe coronary disease since June 2012.
Control Group	Left-only mammary artery grafting	This Group consists of historical control patients who received conventional coronary artery bypass grafting (left mammary artery graft only plus great saphenous vein grafts) in the 2010-2012 period, and who are propensity-matched to the BIMA Group patients.

Primary Outcome Measures

Name	Time	Method
Feasibility of systematic BIMA grafting	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 Outcome Measures

Name	Time	Method
Clinical results at follow-up	2012-2016 (4 years)	The patients enrolled in the study are subjected to longitudinal follow-up to determine the rate of residual myocardial ischemia (periodical stress ECG), of recurrent symptoms of coronary disease, and of any adverse cardiac event (periodical follow-up visits).

Trial Locations

Locations (1)

Policlinico Universitario "A. Gemelli"; 🇮🇹 Rome, Italy