Coronary Artery DiseaseMOZARTNCT03231527
Outcomes of Total Arterial Coronary Artery Bypass Grafting
An observational study of Coronary Artery Disease and Surgical Wound Infection, run by University of Glasgow at 4 sites in 4 countries.
Trial summary
"real-life" retrospective multicentric database for the analysis of the long term outcomes of total arterial CABG in comparison to saphenous vein based CABG Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Surgical Wound Infection
- What is being tested?
- coronary artery bypass grafting (CABG)
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 Feb 2017to Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary elective isolated CABG from multivessel coronary artery disease (CAD
Who may be able to join
- elective CABG patients (on pump or off pump surgery; pedicles of skletonized internal mammary artery harvesting technique; open or endoscopic vein harvesting technique)
Who cannot join
- urgent or emergent CABG
- concomitant procedures
- redo cases
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Multicentric Registry Database of Total Arterial CABG
"real-life" retrospective multicentric database for the analysis of the long term outcomes of total arterial CABG in comparison to saphenous vein based CABG
Read the detailed description
This aim of this registry is to create a multi centric database for the analysis of basic long term outcomes and immediate postoperative outcomes of total arterial CABG in comparison to saphenous vein based CABG. The registry will include both on pump and off pump surgery. The registry is intended to capture the "real-life" picture of the CABG scenario among centers worldwide
- Conditions
- Coronary Artery Disease, Surgical Wound Infection
- Being tested
- coronary artery bypass grafting (CABG)
- Medical subject headings
- Coronary Artery Disease, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary artery bypass grafting (CABG)Procedure or surgery
myocardial revascularization
| Study group | Role | What they receive |
|---|---|---|
| Total Arterial coronary CABG | Total Arterial revascularization Receives: Procedure: coronary artery bypass grafting (CABG) | |
| Saphenous vein based CABG | Saphenous vein based revascularization Receives: Procedure: coronary artery bypass grafting (CABG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Long term survival
Measured: data collection every year up to 5 years after operation/entry in the registry
MACCEs
Major cardiac events (myocardial infarction, stroke, readmission for CHF)
Measured: data collection every year up to 5 years after operation/entry in the registry
target vessel revascularization
readmission for revascularization due to graft failure
Measured: data collection every year up to 5 years after operation/entry in the registry
Wound infection
Readmission for wound infection (superficial sternal wound infection, deep sternal wound infection, saphenous vein related wound infection, need for VAC therapy, need for surgical debridment, need for prolonged antibiotic therapy)
Measured: data collection every year up to 5 years after operation/entry in the registry
Secondary outcomes (9)
Blood product usage
unit of concentrated red cells, fresh frozen plasma, platelets
Measured: perioperative (in hospital)
Bleeding
surgical bleeding requiring re-exploration
Measured: perioperative (in hospital)
Length of ICU stay
number of days in ICU
Measured: perioperative (in hospital)
Length of hospital stay
number of days in hospital
Measured: perioperative (in hospital)
Duration of ventilation
number of hours ventilated
Measured: perioperative (in hospital)
Cardiac complication
prolonged inotropic support (more than 48 hrs), IABP, ECMO
Measured: perioperative (in hospital)
Respiratory complications
pneumonia, reintubation, pneumothorax requiring drainage, effusion requiring drainage
Measured: perioperative (in hospital)
Renal complications
acute kidney injury not requiring dyalisis, dialysis
Measured: perioperative (in hospital)
GI complications
mesenteric ischemia requiring surgery, ileus
Measured: perioperative (in hospital)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start1 Feb 2017
- Primary completionNov 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: research group's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- Campus Bio-Medico University, Universitaire Ziekenhuizen KU Leuven, Thorax Centrum Twente, Golden Jubilee National Hospital
- Responsible party
- Principal investigator, Cristiano Spadaccio, University of Glasgow
- Investigators
- Cristiano Spadaccio, MD, PhD, Principal investigator, Golden Jubilee National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231527
- Sponsor's protocol ID
- UG-002
- Acronym
- MOZART
- Status last verified
- Jul 2020
- First submitted
- 24 Jul 2017
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Registry Database of Total Arterial CABG
- ClinicalTrials.gov ID
- NCT03231527
- Acronym / sponsor ID
- MOZART / UG-002
- Conditions
- Coronary Artery Disease, Surgical Wound Infection
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: research group's decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- Campus Bio-Medico University, Universitaire Ziekenhuizen KU Leuven, Thorax Centrum Twente, Golden Jubilee National Hospital
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 27 Jul 2017 (actual)
- 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.
"real-life" retrospective multicentric database for the analysis of the long term outcomes of total arterial CABG in comparison to saphenous vein based CABG
Detailed description
This aim of this registry is to create a multi centric database for the analysis of basic long term outcomes and immediate postoperative outcomes of total arterial CABG in comparison to saphenous vein based CABG. The registry will include both on pump and off pump surgery. The registry is intended to capture the "real-life" picture of the CABG scenario among centers worldwide
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Arterial coronary CABG | – | Procedure: coronary artery bypass grafting (CABG)Total Arterial revascularization |
| Saphenous vein based CABG | – | Procedure: coronary artery bypass grafting (CABG)Saphenous vein based revascularization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary elective isolated CABG from multivessel coronary artery disease (CAD
Key inclusion criteria (1 listed)
- elective CABG patients (on pump or off pump surgery; pedicles of skletonized internal mammary artery harvesting technique; open or endoscopic vein harvesting technique)
Key exclusion criteria (3 listed)
- urgent or emergent CABG
- concomitant procedures
- redo cases
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 |
|---|---|---|
| coronary artery bypass grafting (CABG)myocardial revascularization | Procedure or surgery | Saphenous vein based CABG, Total Arterial coronary CABG |
Primary outcome
Survival
Time frame: data collection every year up to 5 years after operation/entry in the registry
Long term survival
MACCEs
Time frame: data collection every year up to 5 years after operation/entry in the registry
Major cardiac events (myocardial infarction, stroke, readmission for CHF)
target vessel revascularization
Time frame: data collection every year up to 5 years after operation/entry in the registry
readmission for revascularization due to graft failure
Wound infection
Time frame: data collection every year up to 5 years after operation/entry in the registry
Readmission for wound infection (superficial sternal wound infection, deep sternal wound infection, saphenous vein related wound infection, need for VAC therapy, need for surgical debridment, need for prolonged antibiotic therapy)
9 secondary outcomes
Blood product usage
Time frame: perioperative (in hospital)
Bleeding
Time frame: perioperative (in hospital)
Length of ICU stay
Time frame: perioperative (in hospital)
Length of hospital stay
Time frame: perioperative (in hospital)
Duration of ventilation
Time frame: perioperative (in hospital)
Cardiac complication
Time frame: perioperative (in hospital)
Respiratory complications
Time frame: perioperative (in hospital)
Renal complications
Time frame: perioperative (in hospital)
GI complications
Time frame: perioperative (in hospital)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Cristiano Spadaccio, MD, PhD principal investigator
Golden Jubilee National Hospital
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Surgical Wound Infection, run by University of Glasgow at 4 sites in 4 countries.
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 3 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: withdrawn, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Italy, Netherlands, United Kingdom. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: data collection every year up to 5 years after operation/entry in the registry). The study lists 4 primary outcomes in all. 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 13 Jul 2020.