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The Catholic University BIMA Grafting Study

NCT ID: NCT01593865

Last Updated: 2012-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multivessel Coronary Artery Disease

Keywords

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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BIMA Grafting Group

Group consists of patients who received bilateral internal mammary artery grafting for treatment of severe coronary disease since June 2012.

BIMA Grafting

Intervention Type PROCEDURE

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.

Left-only mammary artery grafting

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catholic University, Italy

OTHER

Sponsor Role lead

Responsible Party

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Mario Gaudino

Researcher at Cardiac Surgery University Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Massimo Massetti, MD

Role: STUDY_DIRECTOR

Division of Cardiac Surgery, Catholic University

Locations

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Policlinico Universitario "A. Gemelli"

Rome, Italy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Massimo Massetti, MD, PhD

Role: CONTACT

Phone: 0039-0630154639

Email: [email protected]

Facility Contacts

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Mario Gaudino, MD

Role: primary

Other Identifiers

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CathUni001

Identifier Type: -

Identifier Source: org_study_id