The Catholic University BIMA Grafting Study (CATHEXIS)
|ClinicalTrials.gov Identifier: NCT01593865|
Recruitment Status : Unknown
Verified August 2012 by Mario Gaudino, Catholic University, Italy.
Recruitment status was: Recruiting
First Posted : May 8, 2012
Last Update Posted : August 21, 2012
|Condition or disease||Intervention/treatment|
|Multivessel Coronary Artery Disease||Procedure: BIMA Grafting Procedure: Left-only mammary artery grafting|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Observational Model:||Case Control|
|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|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||June 2014|
BIMA Grafting Group
Group consists of patients who received bilateral internal mammary artery grafting for treatment of severe coronary disease since June 2012.
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.
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.
Procedure: 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.
- 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.
- Clinical results at follow-up [ Time Frame: 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01593865
|Contact: Massimo Massetti, MD, PhDfirstname.lastname@example.org|
|Policlinico Universitario "A. Gemelli"||Recruiting|
|Rome, Italy, 00168|
|Contact: Mario Gaudino, MD 0039-0630155648 email@example.com|
|Study Director:||Massimo Massetti, MD||Division of Cardiac Surgery, Catholic University|