Outcomes of Total Arterial Coronary Artery Bypass Grafting

Coronary Artery Disease Clinical Trial

— MOZART  

Official title:

Multicentric Registry Database of Total Arterial CABG

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03231527
• Other study ID #: UG-002
• Status: Withdrawn
• Start date: February 1, 2017
• Est. completion date: December 2018

Study information

• Verified date: July 2020
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Surgical Wound
• Surgical Wound Infection
• Wound Infection

Intervention

Procedure:
• coronary artery bypass grafting (CABG)
myocardial revascularization

Locations

Country	Name	City	State
Belgium	Campus St Ian	Genk
Italy	University Campus Bio-Medico	Rome
Netherlands	Thoracic Centrum Twente	Enschede
United Kingdom	Golden Jubilee National Hospital	Glasgow

Sponsors (5)

Lead Sponsor	Collaborator
University of Glasgow	Campus Bio-Medico University, Golden Jubilee National Hospital, Thorax Centrum Twente, Universitaire Ziekenhuizen Leuven

Countries where clinical trial is conducted

Belgium,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Long term survival	data collection every year up to 5 years after operation/entry in the registry
Primary	MACCEs	Major cardiac events (myocardial infarction, stroke, readmission for CHF)	data collection every year up to 5 years after operation/entry in the registry
Primary	target vessel revascularization	readmission for revascularization due to graft failure	data collection every year up to 5 years after operation/entry in the registry
Primary	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	Blood product usage	unit of concentrated red cells, fresh frozen plasma, platelets	perioperative (in hospital)
Secondary	Bleeding	surgical bleeding requiring re-exploration	perioperative (in hospital)
Secondary	Length of ICU stay	number of days in ICU	perioperative (in hospital)
Secondary	Length of hospital stay	number of days in hospital	perioperative (in hospital)
Secondary	Duration of ventilation	number of hours ventilated	perioperative (in hospital)
Secondary	Cardiac complication	prolonged inotropic support (more than 48 hrs), IABP, ECMO	perioperative (in hospital)
Secondary	Respiratory complications	pneumonia, reintubation, pneumothorax requiring drainage, effusion requiring drainage	perioperative (in hospital)
Secondary	Renal complications	acute kidney injury not requiring dyalisis, dialysis	perioperative (in hospital)
Secondary	GI complications	mesenteric ischemia requiring surgery, ileus	perioperative (in hospital)