The Catholic University BIMA Grafting Study (CATHEXIS)

This study is currently recruiting participants.
Verified August 2012 by Catholic University, Italy
Sponsor:
Information provided by (Responsible Party):
Mario Gaudino, Catholic University, Italy
ClinicalTrials.gov Identifier:
NCT01593865
First received: May 5, 2012
Last updated: August 17, 2012
Last verified: August 2012
  Purpose

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 Intervention
Multivessel Coronary Artery Disease
Procedure: BIMA Grafting
Procedure: Left-only mammary artery grafting

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Catholic University, Italy:

Primary Outcome Measures:
  • Feasibility of systematic BIMA grafting [ Time Frame: 2012-2014 (2 years) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 2012-2016 (4 years) ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 1000
Study Start Date: April 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The target study population consists of 1,000 patients undergoing isolated coronary surgery for multivessel disease within a Cardiac Surgery University Department.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593865

Contacts
Contact: Massimo Massetti, MD, PhD 0039-0630154639 m.massetti@rm.unicatt.it

Locations
Italy
Policlinico Universitario "A. Gemelli" Recruiting
Rome, Italy, 00168
Contact: Mario Gaudino, MD    0039-0630155648    mgaudino@tiscali.it   
Sponsors and Collaborators
Catholic University, Italy
Investigators
Study Director: Massimo Massetti, MD Division of Cardiac Surgery, Catholic University
  More Information

No publications provided

Responsible Party: Mario Gaudino, Researcher at Cardiac Surgery University Department, Catholic University, Italy
ClinicalTrials.gov Identifier: NCT01593865     History of Changes
Other Study ID Numbers: CathUni001
Study First Received: May 5, 2012
Last Updated: August 17, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by 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
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014