The Catholic University BIMA Grafting Study (CATHEXIS)
This study is currently recruiting participants.
Verified August 2012 by Catholic University, Italy
Sponsor:
Catholic University, Italy
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 May 21, 2013