Outcomes of Total Arterial Coronary Artery Bypass Grafting (MOZART)

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

Study Overview

• Status: Withdrawn
• Conditions: Coronary Artery Disease; Surgical Wound Infection
• Intervention / Treatment: Procedure: coronary artery bypass grafting (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 Type: Observational

Contacts and Locations

Study Locations

• Belgium
  • Genk, Belgium
    • Campus St Ian
• Italy
  • Rome, Italy
    • University Campus Bio-Medico
• Netherlands
  • Enschede, Netherlands
    • Thoracic Centrum Twente
• United Kingdom
  • Glasgow, United Kingdom
    • Golden Jubilee National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

primary elective isolated CABG from multivessel coronary artery disease (CAD

Description

Inclusion Criteria:

• elective CABG patients (on pump or off pump surgery; pedicles of skletonized internal mammary artery harvesting technique; open or endoscopic vein harvesting technique)

Exclusion Criteria:

• urgent or emergent CABG
• concomitant procedures
• redo cases

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Total Arterial coronary CABG; Total Arterial revascularization	Procedure: coronary artery bypass grafting (CABG); myocardial revascularization
Saphenous vein based CABG; Saphenous vein based revascularization	Procedure: coronary artery bypass grafting (CABG); myocardial revascularization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Long term survival	data collection every year up to 5 years after operation/entry in the registry
MACCEs	Major cardiac events (myocardial infarction, stroke, readmission for CHF)	data collection every year up to 5 years after operation/entry in the registry
target vessel revascularization	readmission for revascularization due to graft failure	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)	data collection every year up to 5 years after operation/entry in the registry

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood product usage	unit of concentrated red cells, fresh frozen plasma, platelets	perioperative (in hospital)
Bleeding	surgical bleeding requiring re-exploration	perioperative (in hospital)
Length of ICU stay	number of days in ICU	perioperative (in hospital)
Length of hospital stay	number of days in hospital	perioperative (in hospital)
Duration of ventilation	number of hours ventilated	perioperative (in hospital)
Cardiac complication	prolonged inotropic support (more than 48 hrs), IABP, ECMO	perioperative (in hospital)
Respiratory complications	pneumonia, reintubation, pneumothorax requiring drainage, effusion requiring drainage	perioperative (in hospital)
Renal complications	acute kidney injury not requiring dyalisis, dialysis	perioperative (in hospital)
GI complications	mesenteric ischemia requiring surgery, ileus	perioperative (in hospital)

Collaborators and Investigators

• Sponsor: University of Glasgow
• Collaborators: Universitaire Ziekenhuizen KU Leuven; Campus Bio-Medico University; Thorax Centrum Twente; Golden Jubilee National Hospital
• Investigators: Principal Investigator: Cristiano Spadaccio, MD, PhD, Golden Jubilee National Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): July 13, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infections; Arteriosclerosis; Arterial Occlusive Diseases; Postoperative Complications; Wounds and Injuries; Coronary Disease; Coronary Artery Disease; Surgical Wound; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: UG-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No