The Catholic University BIMA Grafting Study

Multivessel Coronary Artery Disease Clinical Trial

— CATHEXIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01593865
• Other study ID #: CathUni001
• Status: Recruiting
• Phase: N/A
• First received: May 5, 2012
• Last updated: August 17, 2012
• Start date: April 2012

Study information

• Verified date: August 2012
• Source: Catholic University, Italy
• Contact: Massimo Massetti, MD, PhD
• Phone: 0039-0630154639
• Email: m.massetti[@]rm.unicatt.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Multivessel Coronary Artery Disease
• Myocardial Ischemia

Intervention

Procedure:
• BIMA Grafting
Both the left and the right internal mammary arteries are harvested and used to revascularize the two major coronary targets. Further coronary targets may be revascularized using either great saphenous vein or radial artery grafts, if present.
• Left-only mammary artery grafting
These patients had only the left mammary artery harvested and used to revascularize the major coronary target. Great saphenous vein grafts and/or radial artery grafts were employed to revascularize the remaining targets.

Locations

Country	Name	City	State
Italy	Policlinico Universitario "A. Gemelli"	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of systematic BIMA grafting	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.	2012-2014 (2 years)	Yes
Secondary	Clinical results at follow-up	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).	2012-2016 (4 years)	No