The Catholic University BIMA Grafting Study
CATHEXIS
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
1 other identifier
observational
1,000
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 5, 2012
CompletedFirst Posted
Study publicly available on registry
May 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedAugust 21, 2012
August 1, 2012
2.2 years
May 5, 2012
August 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (1)
Clinical results at follow-up
2012-2016 (4 years)
Study Arms (2)
BIMA Grafting Group
Group consists of patients who received bilateral internal mammary artery grafting for treatment of severe coronary disease since June 2012.
Control Group
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.
Interventions
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.
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.
Eligibility Criteria
The target study population consists of 1,000 patients undergoing isolated coronary surgery for multivessel disease within a Cardiac Surgery University Department.
You may qualify if:
- Patiens undergoing primary or elective-urgent isolated multivessel Coronary Artery Bypass Grafting (CABG) Surgery
You may not qualify if:
- Emergency status
- Previous cardiac operation
- Any associated cardiac procedure other than CABG Surgery
- Left Ventricular Ejection Fraction \<20%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Policlinico Universitario "A. Gemelli"
Rome, Italy, 00168, Italy
Study Officials
- STUDY DIRECTOR
Massimo Massetti, MD
Division of Cardiac Surgery, Catholic University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher at Cardiac Surgery University Department
Study Record Dates
First Submitted
May 5, 2012
First Posted
May 8, 2012
Study Start
April 1, 2012
Primary Completion
June 1, 2014
Last Updated
August 21, 2012
Record last verified: 2012-08