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The Catholic University BIMA Grafting Study

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01593865
Acronym
CATHEXIS
Enrollment
1000
Registered
2012-05-08
Start date
2012-04-30
Completion date
Unknown
Last updated
2012-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multivessel Coronary Artery Disease

Keywords

Coronary Artery Bypass Grafting, Mammary Artery Grafts, Bilateral Mammary Artery Grafting, Clinical Outcomes

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.

Interventions

PROCEDUREBIMA 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.

PROCEDURELeft-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.

Sponsors

Catholic University, Italy
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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%

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of systematic BIMA grafting2012-2014 (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

MeasureTime frameDescription
Clinical results at follow-up2012-2016 (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).

Countries

Italy

Contacts

Primary ContactMassimo Massetti, MD, PhD
m.massetti@rm.unicatt.it0039-0630154639

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026