Multivessel Coronary Artery DiseaseCATHEXISNCT01593865
The Catholic University BIMA Grafting Study
An observational study of Multivessel Coronary Artery Disease, run by Catholic University, Italy at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Multivessel Coronary Artery Disease
- What is being tested?
- BIMA Grafting and Left-only mammary artery grafting
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2012to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target study population consists of 1,000 patients undergoing isolated coronary surgery for multivessel disease within a Cardiac Surgery University Department.
Who may be able to join
- Patiens undergoing primary or elective-urgent isolated multivessel Coronary Artery Bypass Grafting (CABG) Surgery
Who cannot join
- Emergency status
- Previous cardiac operation
- Any associated cardiac procedure other than CABG Surgery
- Left Ventricular Ejection Fraction <20%
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Policlinico Universitario "A. Gemelli"
Rome, Italy, 00168
Mario Gaudino, MD, 0039-0630155648, mgaudino@tiscali.it
About this study
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
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.
- Conditions
- Multivessel Coronary Artery Disease
- Being tested
- BIMA Grafting, Left-only mammary artery grafting
- Keywords
- Coronary Artery Bypass Grafting, Mammary Artery Grafts, Bilateral Mammary Artery Grafting, Clinical Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIMA GraftingProcedure or surgery
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.
Left-only mammary artery graftingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| BIMA Grafting Group | Group consists of patients who received bilateral internal mammary artery grafting for treatment of severe coronary disease since June 2012. Receives: Procedure: BIMA Grafting | |
| 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. Receives: Procedure: Left-only mammary artery grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of systematic BIMA grafting
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.
Measured: 2012-2014 (2 years)
Secondary outcomes (1)
Clinical results at follow-up
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).
Measured: 2012-2016 (4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multivessel Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Gaudino, Catholic University, Italy
- Investigators
- Massimo Massetti, MD, Study director, Division of Cardiac Surgery, Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593865
- Sponsor's protocol ID
- CathUni001
- Acronym
- CATHEXIS
- Status last verified
- Aug 2012
- First submitted
- 5 May 2012
- Last updated
- 21 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01593865
- Acronym / sponsor ID
- CATHEXIS / CathUni001
- Conditions
- Multivessel Coronary Artery Disease
- Keywords
- Coronary Artery Bypass Grafting, Mammary Artery Grafts, Bilateral Mammary Artery Grafting, Clinical Outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Catholic University, ItalyUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2014 (estimated)
- First posted
- 8 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIMA Grafting Group | – | Procedure: BIMA GraftingGroup consists of patients who received bilateral internal mammary artery grafting for treatment of severe coronary disease since June 2012. |
| Control Group | – | Procedure: Left-only mammary artery graftingThis 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target study population consists of 1,000 patients undergoing isolated coronary surgery for multivessel disease within a Cardiac Surgery University Department.
Key inclusion criteria (1 listed)
- Patiens undergoing primary or elective-urgent isolated multivessel Coronary Artery Bypass Grafting (CABG) Surgery
Key exclusion criteria (4 listed)
- Emergency status
- Previous cardiac operation
- Any associated cardiac procedure other than CABG Surgery
- Left Ventricular Ejection Fraction <20%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIMA GraftingBoth 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. | Procedure or surgery | BIMA Grafting Group |
| Left-only mammary artery graftingThese 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. | Procedure or surgery | Control Group |
Primary outcome
Feasibility of systematic BIMA grafting
Time frame: 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.
1 secondary outcome
Clinical results at follow-up
Time frame: 2012-2016 (4 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Massetti, MD study director
Division of Cardiac Surgery, Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multivessel Coronary Artery Disease, run by Catholic University, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Massimo Massetti, MD, PhD (0039-0630154639, m.massetti@rm.unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of systematic BIMA grafting (time frame: 2012-2014 (2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2012.