CATHEXIS: The Catholic University BIMA Grafting Study

Sponsor

Catholic University, Italy (Other)

Overall Status

Unknown status

CT.gov ID

NCT01593865

Collaborator

(none)

1,000

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multivessel Coronary Artery Disease	Procedure: BIMA Grafting Procedure: Left-only mammary artery grafting

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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 :

Apr 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.
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.	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.

Arm

Intervention/Treatment

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.

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.

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.

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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%

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Policlinico Universitario "A. Gemelli"	Rome		Italy	00168

Sponsors and Collaborators

Catholic University, Italy

Investigators

Study Director: Massimo Massetti, MD, Division of Cardiac Surgery, Catholic University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mario Gaudino, Researcher at Cardiac Surgery University Department, Catholic University, Italy

ClinicalTrials.gov Identifier:

NCT01593865

Other Study ID Numbers:

CathUni001

First Posted:

May 8, 2012

Last Update Posted:

Aug 21, 2012

Last Verified:

Aug 1, 2012

Keywords provided by Mario Gaudino, Researcher at Cardiac Surgery University Department, Catholic University, Italy

Coronary Artery Bypass Grafting

Mammary Artery Grafts

Bilateral Mammary Artery Grafting

Clinical Outcomes

Additional relevant MeSH terms:

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Study Results

No Results Posted as of Aug 21, 2012